INTRODUCTION
Background
A diabetic foot ulcer (DFU) can be defined as a full-thickness wound (i.e, involving the subcutaneous tissue) below the ankle, or as a lesion of the foot penetrating through the dermis, in people with type 1 or type 2 diabetes [1][2]. (See Figure 1)
Guidelines, Quality Measures and resources for DFU prevention, assessment and management are listed below. For and introduction and assessment of DFUs including epidemiology, risk factors, etiology, pathophysiology, history, physical examination, diagnosis, differential diagnoses, documentation and ICD-10 coding, see "Diabetic Foot Ulcers - Introduction and Assessment". For DFU management, see "Diabetic Foot Ulcer - Treatment". For DFU prevention, see "Diabetic Foot Ulcer - Prevention".
Figure 1. Diabetic foot ulcer with dry gangrene
Relevance
- DFU is the leading cause of lower-extremity amputation and hospitalization.[3] Once lower extremity amputation due to diabetes has occurred, access to care and treatment seem ineffective in preventing death.[4] Mortality rate (5 year, unadjusted) post diabetes-related amputation is 39%, comparable to that of colorectal cancer.[4]
EVIDENCE-BASED CLINICAL GUIDELINES
Below is a list of the some of the most recent evidence-based guidelines on DFU:
| Evidence-based guideline, Year |
Publishing Organization, Country or Region |
Links |
WHS (Wound Healing Society) guidelines update: Diabetic foot ulcer treatment guidelines, 2024
| Wound Healing Society, USA | Guideline (paid) |
Diagnosis and treatment of diabetic foot ulcer complicated with lower extremity vasculopathy: Consensus recommendation from the Chinese Medical Association (CMA), Chinese Medical Doctor Association (CMDA), 2024
| Chinese Medical Association (CMA) and Chinese Medical Doctor Association (CMDA)
| Guideline (free) |
IWGDF/IDSA Guidelines on the Diagnosis and Treatment of Diabetes-related Foot Infections (IWGDF/IDSA 2023)
| International Working Group on the Diabetic Foot (IWGDF) and Infectious Diseases Society of America , USA
| Guideline (free) |
The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes and a foot ulcer, 2023
| IWGDF, ESVS, SVS
| Guideline (free)
|
Guidelines on the prevention of foot ulcers in persons with diabetes (IWGDF 2023 update), 2023
| International Working Group on the Diabetic Foot (IWGDF)
| Guideline (free) |
Guidelines on interventions to enhance healing of foot ulcers in people with diabetes (IWGDF 2023 update), 2023
| International Working Group on the Diabetic Foot (IWGDF)
| Guideline (free) |
Guidelines on offloading foot ulcers in persons with diabetes (IWGDF 2023 update), 2023
| International Working Group on the Diabetic Foot (IWGDF)
| Guideline (free) |
Australian evidence-based guidelines for the prevention and management of diabetes-related foot disease: a guideline summary, 2022
| Diabetes Feet Australia (DFA; a division of the Australian Diabetes Society)
| Guideline (free) |
Guideline for Management of Patients With Lower-Extremity Wounds Due to Diabetes Mellitus and/or Neuropathic Disease: An Executive Summary, 2021
| Wound, Ostomy and Continence Nurses Society, USA
| Guideline (free) |
IWGDF Guidelines on the Prevention and Management of Diabetic Foot Disease, 2019
| International Working Group on the Diabetic Foot (IWGDF)
| Guideline (free) |
Diabetic Foot Australia guideline on footwear for people with diabetes, 2018
| Australian foot specialists, Australia | Guideline (free) |
Microvascular Complications and Foot Care, 2017
| American Diabetes Association, USA
| Guideline (free)
|
WHS guidelines update: Diabetic foot ulcer treatment
| Wound Healing Society, USA
| Guideline (free)
|
IWGDF guidance on the diagnosis, prognosis and management of peripheral artery disease inpatients with foot ulcers in diabetes, 2016
| International Working Group on the Diabetic Foot (IWGDF)
| Guideline (free)
|
IWGDF guidance on the prevention of foot ulcers in at-risk patients with diabetes, 2016
| International Working Group on the Diabetic Foot (IWGDF)
| Guideline (free)
|
IWGDF guidance on use of interventions to enhance the healing of chronic ulcers of the foot in diabetes, 2016
| International Working Group on the Diabetic Foot (IWGDF)
| Guideline (free)
|
IWGDF guidance on the diagnosis and management of foot infections in persons with diabetes, 2016
| International Working Group on the Diabetic Foot (IWGDF)
| Guideline (free)
|
The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine, 2016
| Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine , USA
| Guideline (free)
|
Diabetic foot problems: prevention and management, 2015
| National Institute for Health and Care Excellence (NICE), UK
| Guideline (free)
|
A clinical practice guideline for the use of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers, 2015
| Undersea and Hyperbaric Medical Society, USA
| Guideline (free)
|
Guideline for the management of wounds in patients with lower-extremity neuropathic disease: an executive summary, 2013
| Wound, Ostomy and Continence Nurses Society, USA
| Guideline (paid)
|
2012 Infectious Diseases Society of America Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections, 2012
| Infectious Diseases Society of America , USA
| Guideline (free)
|
QUALITY MEASURES
Relevant Quality Measures are listed below. For CMS MIPS measures, benchmarks are available on the CMS Quality Payment Program Measures Benchmarks.
| Setting |
CMS Program |
Developed by |
Measure ID |
Title |
Year/ Description/ Benchmark (when available) |
| Outpatient | QPP - MIPS (*)
| US Wound Registry | CDR2 | Outcome measure: Diabetic Foot Ulcer (DFU) Healing or Closure
| Percentage of diabetic foot ulcers among patients age 18 or older that have achieved healing or closure within 6 months, stratified by the Wound Healing Index. Healing or closure is defined as complete epithelialization without drainage or the need for a dressing over the closed ulceration, although venous compression would still be required. Data from prospective studies and real‐world data suggest that DFU healing rates are less than 50% overall, with healing rates of 20% for the most severe. Often, "healing rates" are vetted post hoc by retrospectively classifying patients who do not heal as “palliative care” so that the apparent success of wound care programs is not impacted by patients who do not do well.[5] In 2020, performance rate ranged from 4.1% to 43% with an average performance rate of 21%. This low healing rate is actually consistent with real world healing rates overall and demonstrate why risk stratification is necessary.[6]
|
| Outpatient | QPP - MIPS (*)
| US Wound Registry and the Undersea and Hyperbaric Medical Society (UHMS)
| CDR8 | Appropriate use of hyperbaric oxygen therapy for patients with diabetic foot ulcer | Percent of diabetic foot ulcers graded stage 3 or higher on the Wagner Grading System for Diabetic Foot Infections that received HBOT appropriately, among diabetic foot ulcers receiving HBOT during the reporting period. Prior to receiving HBOT patients must have met the following criteria: Have a diabetic foot ulcer that has not achieved 30% closure after four weeks of treatment, adequate offloading of the diabetic foot ulcer at each visit for four weeks of treatment, vascular screening performed, measurement of BMI with follow-up MIPS #128. As a benchmark, In 2000, the OIG published a report called, “Hyperbaric Oxygen Therapy, Its Use and Appropriateness,” in which it estimated that 32% of payments for HBOT were paid in error ($14.2 million that year). A 2013 retrospective study found that 60% of the diabetic foot ulcers treated with HBOT in the study sample were Wagner Grade 2, confirming that Medicare coverage guidelines of reserving HBOT for Wagner 3 and above were not being followed.[7] Since 2018, the average performance rate has been 10% or less.[8]
|
Outpatient
| QPP - MIPS (*)
| US Wound Registry
| USWR22
| Patient Reported Nutritional Assessment and Intervention Plan in Patients with Wounds and Ulcers
| The percentage of patients aged 18 years and older with a diagnosis of a wound or ulcer of any type who self-report nutritional screening with a validated tool (such as the Self-MNA® by Nestlé) as well as food insecurity assessment, AND for whom the clinician provides an intervention plan within the 12-month reporting period.
|
Outpatient
| QPP - MIPS (*)
| US Wound Registry
| USWR29 (2023), USWR 35 (2024)
| Outcome measure: Adequate Off-loading of Diabetic Foot Ulcers at each visit, appropriate to location of ulcer
| Percentage of visits in which diabetic foot ulcers among patients aged 18 years and received adequate off-loading during a 12-month reporting period, stratified by location of the ulcer. As a benchmark, in 2020, the average performance rate of DFU offloading at each visit for the entire group was 56% with performance ranging from 33% to 100% over the 12-month calendar year.[9]
|
Outpatient
| QPP - MIPS (*)
| US Wound Registry
| USWR30
| Non Invasive Arterial Assessment of patients with lower extremity wounds or ulcers for determination of healing potential
| Percentage of patients aged 18 years or older with a non healing lower extremity wounds or ulcers that underwent a non-invasive arterial assessment once in a 12 month period, stratified by ABI, perfusion pressure, or oximetry. According to the USWR in 2020, clinician performance ranged from 0% to 100% with an average of 57.6% for practitioners that submitted data to CMS 44.6% among clinicians who did not submit quality data.[10]
|
| Outpatient | QPP - MIPS (*)
| Medicare | MIPS1 | Diabetes: Hemoglobin A1c Poor Control
| Percentage of patients 18-75 years of age with diabetes who had hemoglobin A1c > 9.0% during the measurement
period
|
Outpatient
| QPP - MIPS (*)
| Medicare | MIPS 126 | Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy - Neurological Evaluation
| Percentage of patients aged 18 years and older with a diagnosis of diabetes mellitus who had a neurological
examination of their lower extremities within 12 months
|
| Outpatient | QPP - MIPS (*)
| Medicare | MIPS 127 | Diabetes Mellitus: Diabetic Foot and Ankle Care, Ulcer Prevention - Evaluation of Footwear
| Percentage of patients aged 18 years and older with a diagnosis of diabetes mellitus who were evaluated for proper
footwear and sizing
|
Outpatient
| QPP - MIPS (*)
| Medicare
| MIPS 128
| Preventative Care and Screening: Body Mass Index (BMI) Screening and Follow-Up
| Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous twelve months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous twelve months of the current encounter
|
| Outpatient | QPP - MIPS (*)
| National Committee for Quality Assurance
| MIPS 155 | Falls: Plan of Care
| Percentage of patients aged 65 years and older with a history of falls that had a plan of care for falls documented within 12 months.
|
| Outpatient | QPP - MIPS (*)
| Registry Clearinghouse in Collaboration with Ohio Foot and Ankle Medical Association
| REGCLR5
| Offloading with Remote Monitoring
| Percentage of patients with a plantar foot ulcer who were compliant with offloading and healed their ulcer in 10 (ten) weeks. There is consensus that mechanical offloading of a diabetic foot ulcer is the cornerstone of healing. Over 75% of patients who are provided with Off Weight Bearing therapy at the time of treatment are NON-ADHERENT to the treatment plan. On average subjects with diabetic foot ulcerations wear their offloading devices just for 28% of their daily steps.
|
Outpatient
| QPP - MIPS (*)
| Registry Clearinghouse in Collaboration with Ohio Foot and Ankle Medical Association
| REGCLR8
| Monitor and Improve Treatment Outcomes in Chronic Wound Healing
| This measure is specifically for CHRONIC wounds. Those are wounds that have been present for an extended period of time and have not demonstrated healing. Percentage of patients presenting with a non-healing (chronic) wound (present for 6 weeks with no or limited response to treatment) who are currently visiting a provider responsible for their wound care, who performs a re-assessment of the wound (The use of digital imaging to monitor the wound is encouraged) , and has used the information learned from that re-assessment to implement a change in treatment plan, and whose wound healing rate has accelerated since implementation of the updated treatment plan. Reducing error in wound measurement by 35-40% e.g. from 45% to less than 5% will improve wound healing rates and reduce spend on advanced treatments. A digital measurement manufacturer published data illustrating that prolonged use of the system i.e. for greater than or equal to 100 days will have a significant positive impact on wound healing rate.[11]
|
| Retired |
|
|
|
|
|
| Setting | CMS Program | Developed by | Measure ID | Title | Year/ Description/ Benchmark (when available) |
| Outpatient | QPP - MIPS (*)
| US Wound Registry | CDR3 | Process measure: Plan of Care Creation for Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU) not Achieving 30% Closure at 4 Weeks after undergoing treatment with CTP
| 2019 measure; A plan of care needs to be created for patients that fail to achieve 30% of wound closure within 4 weeks of the application of the first CTP, and will include review of whether appropriate usual care has been implemented as well as whether further CTP applications are indicated
|
| Outpatient | QPP - MIPS (*)
| US Wound Registry
| CDR9 | Appropriate use of Cellular and/or Tissue Based Product (CTP) in diabetic foot ulcers (DFUs) or venous leg ulcer (VLUs) among patients 18 years or older
| 2019 measure; Percent of patients 18 or older with venous or diabetic foot ulcer who receive cellular and/or tissue based products (CTPs) appropriately. Appropriate Use of CTPs for a DFU or VLU is defined as use that adheres to Medicare coverage policy regarding the total number of applications over a specific timeframe. Regional Medicare Administrative Carrier (MAC) policies differ but using the most restrictive Local Coverage Determination (LCD), appropriate use is defined as: No more than 10 applications per wound, CTP applications do not continue if the wound is unchanged in size or larger in size after 4 weeks have elapsed from the first application, CTP applications do not continue once the wound is 0.5 cm2 or smaller. Prior to application of a CTP, patient should undergo vascular assessment to exclude ischemia, control bioburden, and debride necrotic material, as well as provide other appropriate basic interventions such as compression of a venous ulcer or offloading of a diabetic foot ulcer. Currently the benchmark rate is only 23%.
|
| Outpatient | QPP - MIPS (*)
| US Wound Registry and the Undersea and Hyperbaric Medical Society (UHMS) | USWR16 | Outcome measure: Major Amputation in Wagner Grade 3, 4, or 5 DFUs Treated with HBOT
| 2019 measure; Percentage of ulcers of patients aged 18 years or older with a diagnosis of a Wagner Grade 3, 4, or 5 diabetic foot ulcer (DFU) whose ulcer has an outcome of major amputation 6 months after completion of a course of HBOT, stratified by the Wound Healing Index.
|
Outpatient
| QPP - MIPS (*)
| US Wound Registry
| USWR24
| Patient Reported Experience of Care: Wound Outcome
| Retired. All eligible patients with wounds or ulcers who completed of Wound Outcome Questionnaire who showed 10% improvement at discharge or transfer to another site of care during the 12 month reporting period.
|
| Outpatient | QPP - MIPS (*)
| US Wound Registry
| USWR27
| Assessment of Nutritionally At-Risk Patients for Malnutrition and Development of Nutrition Recommendations/Interventions by a Registered Dietitian Nutritionist
| Retired. Percentage of patients age 18 years and older who are nutritionally at-risk that have documented nutrition intervention recommendations by a registered dietitian nutritionist or clinical qualified nutrition professional if identified with moderate or severe malnutrition as part of a nutrition assessment. A study by Sherry et. al (2017) demonstrated that only 65% of patients who screened positive for malnutrition risk received any referral to a nutrition professional or an order for nutritional support.[12]
|
| Outpatient | QPP - MIPS (*)
| US Wound Registry
| USWR28
| Obtaining Preoperative Nutritional Recommendations from a Registered Dietitian Nutritionist (RDN) in Nutritionally At-Risk Surgical Patients
| Retired. Percentage of patients age 18 years and older who have undergone a surgical procedure and were identified to be at-risk for malnutrition based on a malnutrition screening OR who were referred to a registered dietitian nutritionist or clinically qualified nutrition professional and have a preoperative nutrition assessment which was documented in the medical record along with documentation of any recommended nutrition interventions.
|
| Outpatient | QPP - MIPS (*)
| US Wound Registry, SCG Health
| SCG2 | Outcome Assessment for Patients Prescribed Ankle Orthosis for Ambulation and Functional Improvement
| 2019 measure; Percentage of of patients 18 years and older who had at least two medical visits during the performance period, and for whom an ankle orthosis was prescribed to assist with ambulation AND report a significant improvement in ambulation and function with the orthosis using a standardized tool within the performance period |
| Outpatient | QPP - MIPS (*)
| US Wound Registry, SCG Health
| SCG3 | Outcome Assessment for Patients Prescribed Foot Orthosis for Ambulation and Functional Improvement
| 2019 measure; Percentage of patients 18 years and older with a deformity of the foot or forefoot, who had at least two medical visits during the performance period, and for whom a foot orthosis was prescribed to assist with ambulation AND report a significant improvement in ambulation and function with the orthosis using a standardized tool within the reporting period
|
| Outpatient | QPP - MIPS (*)
| US Wound Registry, SCG Health
| SCG5 | Improvement in Quality of Life from Partial Foot, Prosthetics
| 2019 measure; Percentage of patients 18 years and older with a prescription f or a partial foot prosthetic to assist with ambulation whose health related quality of life (HRQoL) was assessed during at least two visits during the performance period AND whose health related quality of life score stayed the same or improved |
Outpatient
| QPP - MIPS (*)
| Medicare | MIPS 131
| Pain Assessment and Follow-Up
| 2019 measure. Percentage of visits for patients aged 18 years and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of a follow-up plan when pain is present |
* The Quality Payment Program (QPP) was implemented in the U.S. by Medicare in 2017. Merit-based incentive payment system (MIPS) is designed for eligible clinicians who bill under Medicare Part B. Grayed out measures were deleted/retired.
RESOURCES
CURATED ARTICLES
Multi-centre prospective randomised controlled clinical trial to evaluate a bioactive split thickness skin allograft vs standard of care in the treatment of diabetic foot ulcers., 2022 MayJournal: International wound journal
Diabetic foot ulcers (DFUs) pose a significant risk for infection and limb loss. Advanced wound therapies including human skin allografts have shown promise in resolving these challenging wounds. The primary objective of this randomised, prospective study was to compare the response of 100 subjects with non-healing DFUs of which 50 were treated with a cryopreserved bioactive split thickness skin allograft (BSA) (TheraSkin; Misonix,Inc., Farmingdale, NY) compared with 50 subjects treated with standard of care (SOC, collagen alginate dressing) at 12 weeks. Both groups received standardised care that included glucose monitoring, weekly debridement's as appropriate, and an offloading device. The primary endpoint was proportion of full-thickness wounds healed at 12 weeks, with secondary endpoints including differences in percent area reduction (PAR) at 12 weeks, changes in Semmes-Weinstein monofilament score, VAS pain, and w-QoL. The result illustrated in the intent-to-treat analysis at 12 weeks showed that 76% (38/50) of the BSA-treated DFUs healed compared with 36% (18/50) treated with SOC alone (adjusted P = .00056). Mean PAR at 12 weeks was 77.8% in the BSA group compared with 49.6% in the SOC group (adjusted P = .0019). In conclusion, adding BSA to SOC appeared to significantly improve wound healing with a lower incidence of adverse events related to treatment compared with SOC alone.
© 2022 The Authors. International Wound Journal published by Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd.
View on PubMed View on SourceJournal: Journal of comparative effectiveness research
Aim: Determine the effectiveness of hypothermically stored amniotic membrane (HSAM) versus standard of care (SOC) in diabetic foot ulcers (DFUs). Methods: A randomized controlled trial was conducted on 76 DFUs analyzed digitally. Results: Cox wound closure for HSAM (38 wounds) was significantly greater (p = 0.04) at weeks 12 (60 vs 38%), and 16 (63 vs 38%). The probability of wound closure increased by 75% (Hazard Ratio = 1.75; 95% CI: 1.16-2.70). HSAM showed >60% reductions in area (82 vs 58%; p = 0.02) and depth (65 vs 39%; p = 0.04) versus SOC. Conclusion: HSAM increased frequency and probability of wound closure in DFUs versus SOC.
View on PubMed View on SourceJournal: Diabetes/Metabolism Research and Reviews
Diabetic foot ulcer complicated with lower extremity vasculopathy is highly prevalent, slow healing and have a poor prognosis. The final progression leads to amputation, or may even be life-threatening, seriously affecting patients' quality of life. The treatment of lower extremity vasculopathy is the focus of clinical practice and is vital to improving the healing process of diabetic foot ulcers. Recently, a number of clinical trials on diabetic foot ulcers with lower extremity vasculopathy have been reported. A joint group of Chinese Medical Association (CMA) and Chinese Medical Doctor Association (CMDA) expert representatives reviewed and reached a consensus on the guidelines for the clinical diagnosis and treatment of this kind of disease. These guidelines are based on evidence from the literature and cover the pathogenesis of diabetic foot ulcers complicated with lower extremity vasculopathy and the application of new treatment approaches. These guidelines have been put forward to guide practitioners on the best approaches for screening, diagnosing and treating diabetic foot ulcers with lower extremity vasculopathy, with the aim of providing optimal, evidence-based management for medical personnel working with diabetic foot wound repair and treatment.
© 2024 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.
View on PubMed View on SourceJournal: Clinical Infectious Diseases
The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the management and prevention of diabetes-related foot diseases since 1999. The present guideline is an update of the 2019 IWGDF guideline on the diagnosis and management of foot infections in persons with diabetes mellitus. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was used for the development of this guideline. This was structured around identifying clinically relevant questions in the P(A)ICO format, determining patient-important outcomes, systematically reviewing the evidence, assessing the certainty of the evidence, and finally moving from evidence to the recommendation. This guideline was developed for healthcare professionals involved in diabetes-related foot care to inform clinical care around patient-important outcomes. Two systematic reviews from 2019 were updated to inform this guideline, and a total of 149 studies (62 new) meeting inclusion criteria were identified from the updated search and incorporated in this guideline. Updated recommendations are derived from these systematic reviews, and best practice statements made where evidence was not available. Evidence was weighed in light of benefits and harms to arrive at a recommendation. The certainty of the evidence for some recommendations was modified in this update with a more refined application of the GRADE framework centred around patient important outcomes. This is highlighted in the rationale section of this update. A note is also made where the newly identified evidence did not alter the strength or certainty of evidence for previous recommendations. The recommendations presented here continue to cover various aspects of diagnosing soft tissue and bone infections, including the classification scheme for diagnosing infection and its severity. Guidance on how to collect microbiological samples, and how to process them to identify causative pathogens, is also outlined. Finally, we present the approach to treating foot infections in persons with diabetes, including selecting appropriate empiric and definitive antimicrobial therapy for soft tissue and bone infections; when and how to approach surgical treatment; and which adjunctive treatments may or may not affect the infectious outcomes of diabetes-related foot problems. We believe that following these recommendations will help healthcare professionals provide better care for persons with diabetes and foot infections, prevent the number of foot and limb amputations, and reduce the patient and healthcare burden of diabetes-related foot disease.
© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
View on PubMed View on SourceJournal: Diabetes/Metabolism Research and Reviews
AIMS: Principles of wound management, including debridement, wound bed preparation, and newer technologies involving alternation of wound physiology to facilitate healing, are of utmost importance when attempting to heal a chronic diabetes-related foot ulcer. However, the rising incidence and costs of diabetes-related foot ulcer management necessitate that interventions to enhance wound healing of chronic diabetes-related foot ulcers are supported by high-quality evidence of efficacy and cost effectiveness when used in conjunction with established aspects of gold-standard multidisciplinary care. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence-based guideline on wound healing interventions to promote healing of foot ulcers in persons with diabetes. It serves as an update of the 2019 IWGDF guideline.
MATERIALS AND METHODS: We followed the GRADE approach by devising clinical questions and important outcomes in the Patient-Intervention-Control-Outcome (PICO) format, undertaking a systematic review, developing summary of judgements tables, and writing recommendations and rationale for each question. Each recommendation is based on the evidence found in the systematic review and, using the GRADE summary of judgement items, including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability, we formulated recommendations that were agreed by the authors and reviewed by independent experts and stakeholders.
RESULTS: From the results of the systematic review and evidence-to-decision making process, we were able to make 29 separate recommendations. We made a number of conditional supportive recommendations for the use of interventions to improve healing of foot ulcers in people with diabetes. These include the use of sucrose octasulfate dressings, the use of negative pressure wound therapies for post-operative wounds, the use of placental-derived products, the use of the autologous leucocyte/platelet/fibrin patch, the use of topical oxygen therapy, and the use of hyperbaric oxygen. Although in all cases it was stressed that these should be used where best standard of care was not able to heal the wound alone and where resources were available for the interventions.
CONCLUSIONS: These wound healing recommendations should support improved outcomes for people with diabetes and ulcers of the foot, and we hope that widescale implementation will follow. However, although the certainty of much of the evidence on which to base the recommendations is improving, it remains poor overall. We encourage not more, but better quality trials including those with a health economic analysis, into this area.
© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.
View on PubMed View on SourceJournal: The International Journal of Lower Extremity Wounds
Type 2 diabetes is a significant global health concern. It often causes diabetic foot ulcers (DFUs), which affect millions of people and increase amputation and mortality rates. Despite existing guidelines, the complexity of DFU treatment makes clinical decisions challenging. Large language models such as chat generative pretrained transformer (ChatGPT), which are adept at natural language processing, have emerged as valuable resources in the medical field. However, concerns about the accuracy and reliability of the information they provide remain. We aimed to assess the accuracy of various artificial intelligence (AI) chatbots, including ChatGPT, in providing information on DFUs based on established guidelines. Seven AI chatbots were asked clinical questions (CQs) based on the DFU guidelines. Their responses were analyzed for accuracy in terms of answers to CQs, grade of recommendation, level of evidence, and agreement with the reference, including verification of the authenticity of the references provided by the chatbots. The AI chatbots showed a mean accuracy of 91.2% in answers to CQs, with discrepancies noted in grade of recommendation and level of evidence. Claude-2 outperformed other chatbots in the number of verified references (99.6%), whereas ChatGPT had the lowest rate of reference authenticity (66.3%). This study highlights the potential of AI chatbots as tools for disseminating medical information and demonstrates their high degree of accuracy in answering CQs related to DFUs. However, the variability in the accuracy of these chatbots and problems like AI hallucinations necessitate cautious use and further optimization for medical applications. This study underscores the evolving role of AI in healthcare and the importance of refining these technologies for effective use in clinical decision-making and patient education.
View on PubMed View on SourceJournal: Circulation
Despite the known higher risk of cardiovascular disease in individuals with type 2 diabetes, the pathophysiology and optimal management of diabetic foot ulcers (DFUs), a leading complication associated with diabetes, is complex and continues to evolve. Complications of type 2 diabetes, such as DFUs, are a major cause of morbidity and mortality and the leading cause of major lower extremity amputation in the United States. There has recently been a strong focus on the prevention and early treatment of DFUs, leading to the development of multidisciplinary diabetic wound and amputation prevention clinics across the country. Mounting evidence has shown that, despite these efforts, amputations associated with DFUs continue to increase. Furthermore, due to increasing patient complexity of management secondary to comorbid conditions, such as cardiovascular disease, the management of peripheral artery disease associated with DFUs has become increasingly difficult, and care delivery is often episodic and fragmented. Although structured, process-specific approaches exist at individual institutions for the management of DFUs in the cardiovascular patient population, there is insufficient awareness of these principles in the general medicine communities. Furthermore, there is growing interest in better understanding the mechanistic underpinnings of DFUs to better define personalized medicine to improve outcomes. The goals of this scientific statement are to provide salient background information on the complex pathogenesis and current management of DFUs in cardiovascular patients, to guide therapeutic and preventive strategies and future research directions, and to inform public policy makers on health disparities and other barriers to improving and advancing care in this expanding patient population.
View on PubMed View on SourceJournal: Diabetes/Metabolism Research and Reviews
AIMS: Offloading mechanical tissue stress is arguably the most important of multiple interventions needed to heal diabetes-related foot ulcers. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence-based guideline on offloading interventions to promote healing of foot ulcers in persons with diabetes. It serves as an update of the 2019 IWGDF guideline.
MATERIALS AND METHODS: We followed the GRADE approach by devising clinical questions and important outcomes in the PICO (Patient-Intervention-Control-Outcome) format, undertaking a systematic review and meta-analyses, developing summary of judgement tables and writing recommendations and rationales for each question. Each recommendation is based on the evidence found in the systematic review, expert opinion where evidence was not available, and a careful weighing of GRADE summary of judgement items including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability.
RESULTS: For healing a neuropathic plantar forefoot or midfoot ulcer in a person with diabetes, use a non-removable knee-high offloading device as the first-choice offloading intervention. If contraindications or patient intolerance to non-removable offloading exist, consider using a removable knee-high or ankle-high offloading device as the second-choice offloading intervention. If no offloading devices are available, consider using appropriately fitting footwear combined with felted foam as the third-choice offloading intervention. If such a non-surgical offloading treatment fails to heal a plantar forefoot ulcer, consider an Achilles tendon lengthening, metatarsal head resection, joint arthroplasty, or metatarsal osteotomy. For healing a neuropathic plantar or apex lesser digit ulcer secondary to flexibile toe deformity, use digital flexor tendon tenotomy. For healing rearfoot, non-plantar or ulcers complicated with infection or ischaemia, further recommendations have been outlined. All recommendations have been summarised in an offloading clinical pathway to help facilitate the implementation of this guideline into clinical practice.
CONCLUSION: These offloading guideline recommendations should help healthcare professionals provide the best care and outcomes for persons with diabetes-related foot ulcers and reduce the person's risk of infection, hospitalisation and amputation.
© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.
View on PubMed View on SourceJournal: Current diabetes reviews
BACKGROUND: Diabetic Foot is a severe chronic complication of diabetes and an important factor in the morbidity of diabetic people, resulting in high health costs and increased risk of death.
OBJECTIVE: to analyze the incidence, prevalence, and risk factors associated with diabetic foot in people with type 2 Diabetes Mellitus.
METHOD: Systematic literature review. Searches in MedLine via PubMed, LILACS, Web of Science, Scopus CINAHL, and Cochrane Library databases were performed. Inclusion of 52 studies. The R program, Metan packages, was used to calculate the meta-analysis. Given the heterogeneity of studies, the random effect was used to calculate the meta-analysis of risk factors.
RESULTS: The meta-analysis showed that the prevalence of diabetic foot was 14% in a hospital setting and 5% in a community setting. The overall prevalence and incidence were 9% and 4%, respectively. Significant risk factors included time of DM (odds ratio [OR] =1.46, confidence interval [CI], 0.36-2.57, P = 0.009), smoking (OR = 1.46, CI, 1.16 -1.85, P< .001), glycated hemoglobin (OR = 0.96, CI, 0.50; 1.42, P< .001), peripheral arterial disease (OR = 3.38, CI, 2.07; 5.53, P < .001) and peripheral neuropathy (OR = 5.88, CI, 2.39-14.45, P< .001).
CONCLUSION: Multidisciplinary monitoring, educational strategies, periodic foot examination for alterations, and early identification of risk factors are essential to prevent ulceration and reduce the disease burden.
Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.
View on PubMed View on SourceJournal: Diabetes/Metabolism Research and Reviews
BACKGROUND: Classification and scoring systems can help both clinical management and audit the outcomes of routine care.
AIM: This study aimed to assess published systems used to characterise ulcers in people with diabetes to determine which should be recommended to (a) aid communication between health professionals, (b) predict clinical outcome of individual ulcers, (c) characterise people with infection and/or peripheral arterial disease, and (d) audit to compare outcomes in different populations. This systematic review is part of the process of developing the 2023 guidelines to classify foot ulcers from the International Working Group on Diabetic Foot.
METHODS: We searched PubMed, Scopus and Web of Science for articles published up to December 2021 which evaluated the association, accuracy or reliability of systems used to classify ulcers in people with diabetes. Published classifications had to have been validated in populations of >80% of people with diabetes and a foot ulcer.
RESULTS: We found 28 systems addressed in 149 studies. Overall, the certainty of the evidence for each classification was low or very low, with 19 (68%) of the classifications being assessed by ≤ 3 studies. The most frequently validated system was the one from Meggitt-Wagner, but the articles validating this system focused mainly on the association between the different grades and amputation. Clinical outcomes were not standardized but included ulcer-free survival, ulcer healing, hospitalisation, limb amputation, mortality, and cost.
CONCLUSION: Despite the limitations, this systematic review provided sufficient evidence to support recommendations on the use of six particular systems in specific clinical scenarios.
© 2023 John Wiley & Sons Ltd.
View on PubMed View on SourceJournal: Diabetes/Metabolism Research and Reviews
BACKGROUND: This publication represents a scheduled update of the 2019 guidelines of the International Working Group of the Diabetic Foot (IWGDF) addressing the use of systems to classify foot ulcers in people with diabetes in routine clinical practice. The guidelines are based on a systematic review of the available literature that identified 28 classifications addressed in 149 articles and, subsequently, expert opinion using the GRADE methodology.
METHODS: First, we have developed a list of classification systems considered as being potentially adequate for use in a clinical setting, through the summary of judgements for diagnostic tests, focussing on the usability, accuracy and reliability of each system to predict ulcer-related complications as well as use of resources. Second, we have determined, following group debate and consensus, which of them should be used in specific clinical scenarios. Following this process, in a person with diabetes and a foot ulcer we recommend: (a) for communication among healthcare professionals: to use the SINBAD (Site, Ischaemia, Bacterial infection, Area and Depth) system (first option) or consider using WIfI (Wound, Ischaemia, foot Infection) system (alternative option, when the required equipment and level of expertise is available and it is considered feasible) and in each case the individual variables that compose the systems should be described rather than a total score; (b) for predicting the outcome of an ulcer in a specific individual: no existing system could be recommended; (c) for characterising a person with an infected ulcer: the use of the IDSA/IWGDF classification (first option) or consider using the WIfI system (alternative option, when the required equipment and level of expertise is available and it is considered as feasible); (d) for characterising a person with peripheral artery disease: consider using the WIfI system as a means to stratify healing likelihood and amputation risk; (e) for the audit of outcome(s) of populations: the use of the SINBAD score.
CONCLUSIONS: For all recommendations made using GRADE, the certainty of evidence was judged, at best, as being low. Nevertheless, based on the rational application of current data this approach allowed the proposal of recommendations, which are likely to have clinical utility.
© 2023 John Wiley & Sons Ltd.
View on PubMed View on SourceJournal: Diabetes/Metabolism Research and Reviews
AIMS: This is the 2023 International Working Group on the Diabetic Foot guideline on the prevention of foot ulcers in persons with diabetes, which updates the 2019 guideline. This guideline is targeted at clinicians and other healthcare professionals.
MATERIALS AND METHODS: We followed the Grading of Recommendations, Assessment, Development and Evaluations methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature including, where appropriate, meta-analyses, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where (sufficient) evidence was not available, and a weighing of the desirable and undesirable effects of an intervention, as well as patient preferences, costs, equity, feasibility and applicability.
RESULTS: We recommend screening a person with diabetes at very low risk of foot ulceration annually for the loss of protective sensation and peripheral artery disease, and screening persons at higher risk at higher frequencies for additional risk factors. For preventing a foot ulcer, educate persons at-risk about appropriate foot self-care, educate not to walk without suitable foot protection, and treat any pre-ulcerative lesion on the foot. Educate moderate-to-high risk people with diabetes to wear properly fitting, accommodative, therapeutic footwear, and consider coaching them to monitor foot skin temperature. Prescribe therapeutic footwear that has a demonstrated plantar pressure relieving effect during walking, to help prevent plantar foot ulcer recurrence. Consider advising people at low-to-moderate risk to undertake a, preferably supervised, foot-ankle exercise programme to reduce ulcer risk factors, and consider communicating that a total increase in weight-bearing activity of 1000 steps/day is likely safe with regards to risk of ulceration. In people with non-rigid hammertoe with pre-ulcerative lesion, consider flexor tendon tenotomy. We suggest not to use a nerve decompression procedure to help prevent foot ulcers. Provide integrated foot care for moderate-to-high-risk people with diabetes to help prevent (recurrence of) ulceration.
CONCLUSIONS: These recommendations should help healthcare professionals to provide better care for persons with diabetes at risk of foot ulceration, to increase the number of ulcer-free days and reduce the patient and healthcare burden of diabetes-related foot disease.
© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.
View on PubMed View on SourceJournal: Diabetic Medicine
INTRODUCTION: Topical oxygen therapy (TOT) has been suggested as a treatment for diabetes- related foot ulcer (DFU) but no prior meta-analyses of randomised clinical trials (RCT) have been reported. This systematic review and meta-analysis examined the randomised evidence for the benefit of TOT in healing DFU.
METHODS: Publicly available databases were searched for RCTs investigating the effect of TOT on wound healing in participants with a DFU. The primary outcome was ulcer healing defined as full epithelialisation. Meta-analyses were performed using random effect models and reported as risk ratios (RR) and 95% confidence intervals (CI). Study quality and publication bias were assessed using a modified version of the Cochrane Collaboration's tool and funnel plots respectively.
RESULTS: Six RCTs involving 530 participants with a DFU testing TOT were included. Meta-analysis suggested that TOT significantly increased the likelihood of ulcer healing compared to controls (Risk ratio (RR) 1.94; 95% CI 1.19, 3.17; I2 =57%; NNT=5.33) and findings were robust in sensitivity analyses. Risk of bias was high, moderate and low in two, one and three studies respectively. Analysis of the three trials judged to be at low risk of bias suggested that TOT increased the likelihood of ulcer healing compared to controls (RR 2.37; 95% CI 1.52, 3.68; I2 =0%). Funnel plots suggested the possibility of publication bias. Data on amputation were too limited for meta-analysis.
CONCLUSION: This meta-analysis suggests that TOT improves the likelihood of DFU healing, however, its effect on amputation and cost-effectiveness are unclear.
This article is protected by copyright. All rights reserved.
View on PubMed View on SourceJournal: Pharmaceuticals (Basel, Switzerland)
Chronic wounds often occur in patients with diabetes mellitus due to the impairment of wound healing. This has negative consequences for both the patient and the medical system and considering the growing prevalence of diabetes, it will be a significant medical, social, and economic burden in the near future. Hence, the need for therapeutic alternatives to the current available treatments that, although various, do not guarantee a rapid and definite reparative process, appears necessary. We here analyzed current treatments for wound healing, but mainly focused the attention on few classes of drugs that are already in the market with different indications, but that have shown in preclinical and few clinical trials the potentiality to be used in the treatment of impaired wound healing. In particular, repurposing of the antiglycemic agents dipeptidylpeptidase 4 (DPP4) inhibitors and metformin, but also, statins and phenyotin have been analyzed. All show encouraging results in the treatment of chronic wounds, but additional, well designed studies are needed to allow these drugs access to the clinics in the therapy of impaired wound healing.
View on PubMed View on SourceJournal: Journal of Wound, Ostomy, and Continence Nursing
This article provides an executive summary of the Wound, Ostomy, and Continence Nurses Society's (WOCN) "2021 Guideline for Management of Patients With Lower-Extremity wounds Due to Diabetes Mellitus and/or Neuropathic Disease." This executive summary presents an overview of the systematic process used to update and develop the guideline and recommendations from the guideline for screening and diagnosis, assessment, and management and education of patients with lower-extremity wounds due to diabetes mellitus and/or neuropathic disease. In addition, the executive summary provides suggestions for implementing recommendations from the guideline. The guideline is a resource for WOC nurse specialists and other nurses and health care professionals who work with adults who have/or are at risk for lower-extremity wounds due to diabetes mellitus/neuropathic disease. The complete guideline includes the evidence and references supporting the recommendations, and it is available in print and electronically from the Wound, Ostomy, and Continence Nurses Society, 1120 Rt 73, Suite 200, Mount Laurel, New Jersey, 08054; Web site: www.wocn.org.
Copyright © 2022 by the Wound, Ostomy and Continence Nurses Society.
View on PubMed View on SourceJournal: Journal of clinical medicine
This study aimed to validate the association between the grades of severity of diabetic foot ulcers (DFUs) identified by the fast-tack model and specific outcomes. Three hundred and sixty-seven patients with new DFUs who were referred to a tertiary level diabetic foot service serving Rome, Italy, were included. The fast-track model identifies three levels of DFUs' severity: uncomplicated DFUs, including superficial wounds, not-infected wounds, and not-ischemic wounds; complicated DFUs, including ischemic wounds, infected wounds, and deep ulcers involving the muscles, tendons, or bones, and any kind of ulcers in patients on dialysis and/or with heart failure; and severely complicated DFUs, including abscesses, wet gangrene, necrotizing fasciitis, fever, or clinical signs of sepsis. Healing, minor and major amputation, hospitalization, and survival after 24 weeks of follow-up were considered. Among the included patients, 35 (9.6%) had uncomplicated DFUs, 210 (57.2%) had complicated DFUs, and 122 (33.2%) had severely complicated DFUs. The outcomes for patients with uncomplicated, complicated, and severely complicated DFUs were as follows, respectively: healing, 97.1%, 86.2%, and 69.8%; minor amputation, 2.9%, 20%, and 66.4%; major amputation, 0%, 2.9%, and 16.4%; hospitalization, 14.3%, 55.7%, and 89.3%; survival, 100%, 96.7%, and 89.3%. DFU severity was an independent predictor of healing, amputation, hospitalization, and survival. The current study shows an association between the grade of severity of DFUs identified by the fast-track model and the considered outcomes. The fast-track model may be a useful tool for assessing the severity and prognosis of DFUs.
View on PubMed View on SourceJournal: Journal of clinical medicine
Autologous and recombinant biologic substances have been generated as a result of the research into the cellular features of the healing process. Orthobiologics are increasingly being used in sports medicine and musculoskeletal surgery. Nevertheless, clinical data are limited; consequently, further studies are required, particularly in foot and ankle pathologies. This review aims to provide evidence of the most recent literature results and ignite the interest of orthopedic specialists eager for an update about the most current discussion on platelet-rich plasma (PRP) clinical applications in the foot and ankle fields. Previous studies have shown that platelet-rich plasma can be beneficial in treating various conditions, such as chronic foot ulcers, osteoarthritis, Achilles tendinopathy, etc. Despite the positive effects of PRP on various musculoskeletal conditions, more prospective studies are needed to confirm its effectiveness at treating ankle and foot pathologies. In addition to clinical trials, other factors, such as the quality of the research and the procedures involved, must be considered before they can be used in patients. More long-term evaluations are needed to support or oppose its application in treating foot and ankle disorders. We present the most extensive review of PRP's clinical applications in the foot and ankle field.
View on PubMed View on SourceJournal: Sensors (Basel, Switzerland)
Adherence to prescribed footwear is essential to prevent diabetes-related foot ulcers. The aim was to compare different measures of adherence and wearing time of prescribed footwear with a reference adherence measure, among people with diabetes at high risk of foot ulceration. We followed 53 participants for 7 consecutive days. A temperature sensor measured wearing time of prescribed footwear and a triaxial accelerometer assessed weight-bearing activities. Subjective wearing time was self-reported. Reference adherence measure was proportion of weight-bearing time prescribed footwear was worn. We calculated Spearman's correlation coefficients, kappa coefficients, and areas under the curve (AUC) for the association between the reference measure and other measures of adherence and wearing time. Proportion of daily steps with prescribed footwear worn had a very strong association (r = 0.96, Κ = 0.93; AUC: 0.96-1.00), objective wearing time had a strong association (r = 0.91, Κ = 0.85, AUC: 0.89-0.99), and subjective wearing time had a weak association (r = 0.42, Κ = 0.38, AUC: 0.67-0.81) with the reference measure. Objectively measured proportion of daily steps with prescribed footwear is a valid measure of footwear adherence. Objective wearing time is reasonably valid, and may be used in clinical practice and for long-term measurements. Subjective wearing time is not recommended to be used.
View on PubMed View on SourceJournal: Seminars in musculoskeletal radiology
Management of the diabetic foot is complex and challenging, requiring a multidisciplinary approach. Imaging plays an important role in the decision-making process regarding surgery. This article discusses the presurgical perspective and postsurgical evaluation of the diabetic foot.
Thieme. All rights reserved.
View on PubMed View on SourceJournal: Journal of Wound Care
OBJECTIVE: The aim of this systematic review was to determine the impact of topical oxygen therapy (TOT) on diabetic foot ulcer (DFU) healing.
METHOD: Using systematic review methodology, we considered randomised controlled trials (RCTs), controlled trials, pilot studies and observational studies. The search was conducted in January 2019, using PubMed, CINAHL, Ovid, Cochrane, Web of Science and EMBASE databases. Data analysis was undertaken using RevMan and a narrative synthesis. The article titles were assessed by two authors independently, and the abstracts (when available) of the studies identified by the search strategy were screened for their eligibility, according to the inclusion and exclusion criteria. The full-text version of potentially relevant studies was obtained and two authors independently screened this against the inclusion criteria. Data were extracted using a predesigned extraction tool and all included studies were quality appraised using the Evidence-Based Librarianship checklist.
RESULTS: The search returned 565 records of which eight met the inclusion criteria. Of the included studies, three were set in single centre outpatient wound clinics, two studies were set in an outpatient wound care research clinic and three studies were multisite. Meta-analysis of four studies was undertaken. DFUs are >2 times more likely to heal with TOT than with standard care alone. The odds ratio (OR)=2.49 (95% confidence interval (CI): 1.59-3.90, p=0.00001). The remaining four studies also showed that using TOT increased healing rates. An included study reported that time to 50% DFU closure was significantly shorter in participants who received the TOT, mean 18.4 days versus 28.9 days in the sham therapy group (p=0.001). However, the validity of 65.5% of the eight studies was assessed as low.
CONCLUSION: The findings suggest that TOT enhances healing for patients with hard-to-heal DFUs when used with standard care. The results from the trials reviewed also indicate a benefit for patients over standard care alone. However, the sample sizes in the studies were generally small, thus, more RCTs are warranted to further validate these findings.
DECLARATION OF INTEREST: The authors have no conflicts of interest to declare.
View on PubMed View on SourceJournal: Annals of palliative medicine
BACKGROUND: Negative pressure wound therapy (NPWT) is one of the new modality for the treatment of diabetic foot ulcers. In this article we will investigate the efficacy and safety of it by literature search and meta-analysis.
METHODS: The databases of PubMed, Embase, Ovid, and Cochrane library were selected as search platforms. Randomized controlled trials (RCTs) published after 2010 were searched with the keyword "vacuum-assisted closure therapy" OR "negative pressure wound therapy" OR "diabetic foot". The Cochrane Review Handbook was used to assess the bias of the literatures. The software RevMan 5.4 was used for analysis to obtain a forest plot and funnel plot.
RESULTS: In this study, 363 articles were initially screened, and 9 literatures were finally included, involving a total of 943 patients. Combined analysis using the fixed effects model showed that the healing rate of the NPWT group was significantly lower than the standard group [odds ratio (OR) =3.60, 95% confidence interval (CI): 2.38 to 5.45, P< 0.001]. The granulation tissue formation time of the NPWT group was significantly less than the standard group [mean difference (MD) =-8.95, 95% CI: -10.26 to -7.64, P< 0.001]. The rate of adverse events of both groups showed no significant difference (OR =0.49, 95% CI: 0.10 to 2.42, P=0.38). The amputation rate of both groups showed no statistically significant (OR =0.33, 95% CI: 0.09 to 1.26, P=0.10) too.
DISCUSSION: Negative pressure wound therapy can effectively accelerate wound healing, it is equally safe with general routine treatment. However, the negative pressure value should be appropriately maintained and adjusted to avoid bleeding tendency of the wound when applying this new modality.
View on PubMed View on SourceJournal: Frontiers in endocrinology
Background: Diabetic foot ulcers are a major complication of diabetes mellitus (DM), when heparin and heparin related substances may be potentially used as an adjuvant treatment. We aimed to evaluate the efficacy and safety of heparin and heparin related substances for the treatment of diabetic foot ulcers.
Methods: We searched up to March 2021 in the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; EBSCO CINAHL; VIP Chinese Science and Technique Journals Database; China National Knowledge Infrastructure (CNKI) Database and Wan Fang Database investigating heparin or heparin-related substances in patients with diabetic foot ulcers. The primary outcomes included proportion of ulcers completely healed and time to complete ulcer healing. We assessed each included study with the Cochrane 'Risk of bias' tool and used the GRADE approach to assess the overall quality of the evidence.
Results: We included nine randomized studies involving 620 participants in the meta-analysis, involving two different heparin and heparin-related substances, low molecular weight heparin (LMWH) and hyaluronic acid. Our study did not show the benefits from LMWH on increasing chance of the ulcer healing (RR: 1.26; 95% CI: 0.78 to 2.04; P=0.35; very low) or shortening the time to complete ulcer healing (SMD: 0.13 d; 95% CI: -0.29 to 0.56; P=0.54; very low). Hyaluronic acid may improve the complete ulcer healing (RR: 1.57; 95% CI: 1.29 to 1.91; P˂0.00001; very low) and shorten the time to complete ulcer healing (SMD -0.84, 95% CI -1.15 to -0.53; P< 0.00001; low). Hyaluronic acid and LMWH were generally well tolerated for treating diabetic foot ulcers in this review.
Conclusion: Hyaluronic acid may improve diabetic foot ulcer with very low quality evidence but not LMWH. However, the benefits and harms need further validation in larger trials with different population.
Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/], identifier [PROSPERO, CRD42021269212].
Copyright © 2022 Su, Xu, Li, Zheng, Wu, Zhang, Zhou, Du and Zhao.
View on PubMed View on SourceJournal: British journal of community nursing
This article explores how nurses can use evidence-based practice to appraise the rationale and evidence for specific nursing procedures or practices. A literature review of published evidence on honey dressings for diabetic foot ulcers was conducted by a novice researcher (lead author) under the supervision of a lecturer (second author). A methodology was followed to construct an answerable research question and to guide the search and retrieval of evidence. The strengths and limitations of a selected study were appraised, and its implications for practice considered. This article highlights an area of practice that warrants further attention and demonstrates the use of evidence-based practice to consider the quality and utility of clinical research.
View on PubMed View on SourceJournal: Advances in wound care
Background: This study sought to examine the real-world impact of multimodality cyclical-pressure topical wound oxygen therapy (TWO2) on hospitalizations and amputations in patients with diabetic foot ulcer (DFU) compared with patients without TWO2. Methods: We conducted a retrospective review of deidentified patient medical records at 2 U.S. Veterans Affairs hospitals between January 2012 and January 2020. DFU patients were assigned to TWO2 or NO TWO2 cohorts based on their treatment records. Patients received appropriate standard of care and may have received other advanced wound treatments, including skin substitutes, negative pressure wound therapy, and growth factors. Primary study outcomes were patients requiring hospitalization and/or amputation within 360 days of initial wound documentation. Findings: Among unmatched cohorts of 202 patients with DFU (91 TWO2, 111 NO TWO2), 6.6% and 12.1% of TWO2 patients had hospitalizations and amputations, respectively, compared with 54.1% and 41.4% of NO TWO2 patients within 360 days (p < 0.0001, p < 0.0001), representing 88% and 71% reductions. Among propensity score-matched cohorts of 140 DFU patients (70 TWO2, 70 NO TWO2), compared with NO TWO2, 82% fewer TWO2 patients were hospitalized (7.1% vs. 40.0%, p < 0.0001) and 73% fewer TWO2 patients had amputations (8.6% vs. 31.4%, p = 0.0007). Logistic regression among matched cohorts demonstrated nearly ninefold and fivefold higher risk of hospitalization and amputation, respectively, for NO TWO2 versus TWO2. Interpretation: This retrospective cohort study demonstrates that treating patients with DFU with TWO2 is associated with significant reductions in hospitalizations and amputations in the real-world setting.
View on PubMed View on SourceJournal: Advances in skin & wound care
OBJECTIVE: To discuss human amnion chorion (placental) membrane allograft (HACMA) use for the treatment of chronic diabetic foot ulcers (DFUs) and to evaluate the effectiveness, cost, and product waste of this therapy.
DATA SOURCES: PubMed, Cochrane, and OVID databases.
STUDY SELECTION: Twenty-four articles pertaining to HACMA and DFUs published from 2016 to 2020 were selected.
DATA EXTRACTION: The data collected included type of wound care product, study design, study size, baseline size of DFU, cost, product wastage, number of applications, and wound healing outcomes.
DATA SYNTHESIS: Human amnion chorion membrane allografts in the treatment of chronic DFUs have led to a reduction in healing time and increased the overall percentage of healing, making them more effective in treating DFUs compared with standard of care. These products are offered in multiple sizes with various shelf lives and methods of storage, making them accessible, easy to use, less wasteful, and lower in cost compared with other commercially available products. Promising evidence demonstrates that HACMAs are beneficial in treating complex, high-grade DFUs with exposed tendon or bone.
CONCLUSIONS: Human amnion chorion membrane allografts are effective in treating chronic DFUs with a greater percentage of complete wound closure and a reduction in healing time versus standard of care.
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
View on PubMed View on SourceJournal: Wound Repair and Regeneration
A prospective, single arm feasibility study was conducted to evaluate healing outcomes of DFUs treated with autologous skin cell suspension (ASCS) in combination with standard therapy. Wounds up to 100 cm2 in size that failed to heal with conventional therapy were included and wound healing, pain, exudate scores, Quality of Life, satisfaction scores, and safety outcomes were evaluated over a period of 26 weeks. Sixteen subjects were enrolled having a mean DFU duration of 60.4 weeks. All ulcers in this study had a positive healing trajectory, with a mean reepithelialization of 84.9% and 12.2 cm2 reduction in ulcer area. For ulcers that did not acquire a soft tissue infection post-treatment, all either healed or achieved ≥95% reepithelialization including some with exposed tendon. Improvements were observed in all aspects of the health-related Quality of Life questionnaire and subjects and clinicians were highly satisfied across all postoperative visits. This preliminary study suggests ASCS is a well-tolerated and promising therapy for the treatment of DFUs as all ulcers evaluated experienced positive healing results regardless of size, depth, and wound duration. Future studies are warranted to investigate ASCS compared to standard of care for all diabetic foot ulcers, inclusive of the evaluation of treatment algorithms and combination products.
© 2020 The Authors. Wound Repair and Regeneration published by Wiley Periodicals LLC on behalf of The Wound Healing Society.
View on PubMed View on SourceJournal: The International Journal of Lower Extremity Wounds
Diabetic foot ulcer is one of the most devastating complications of uncontrolled diabetes. Although there have been advances in the management of diabetic foot ulcers, still diabetic foot ulcers are a major cause of many amputations in diabetic patients. Teucrium polium (T. polium) is widely used by folk medicine practitioners in Iran for the treatment of diabetic ulcers.The present study was designed to evaluate the safety and efficacy of topical T. polium ointment besides the standard treatment in diabetic foot ulcers.A total of 70 diabetic patients with foot ulcers grade 1 or 2 according to Wagner's scale were enrolled in this study. Patients were randomly divided into two groups. Patients in both groups received standard treatment for diabetic foot ulcers. In addition, group 1 received topical T. polium ointment, and group 2 received topical placebo ointment for 4 weeks. The T. polium and placebo ointments were rubbed twice daily two hours before the conventional dressing. The ulcer size, healing time, and laboratory tests were measured in both groups at baseline and end of the study after 4 weeks.Twenty-nine patients remained in the T. polium group and 26 in the placebo group until the end of the study. The mean surface area of ulcers was 3.52 ± 1.47 and 3.21 ± 1.67 cm2 in T. polium group and placebo group respectively at baseline which decrease to .717 ± .19 and 1.63 ± .72 cm2 respectively at the endpoint. The mean ulcer surface area was significantly lower in T. polium compared with the placebo group (p < .0001) at end of the study. Also, the number of patients that completely recovered in the T. polium group was significantly higher than the placebo group (p < .001) at the end of the study.The addition of topical T. polium ointment to standard treatment significantly improves the healing time of diabetic non-infected foot ulcers.
View on PubMed View on SourceJournal: Journal of diabetes science and technology
BACKGROUND: Diabetic foot ulcers (DFUs) are a leading cause of disability and morbidity. There is an unmet need for a simple, practical, home method to detect DFUs early and remotely monitor their healing.
METHOD: We developed a simple, inexpensive, smartphone-based, "Foot Selfie" system that enables patients to photograph the plantar surface of their feet without assistance and transmit images to a remote server. In a pilot study, patients from a limb-salvage clinic were asked to image their feet daily for six months and to evaluate the system by questionnaire at five time points. Transmitted results were reviewed weekly.
RESULTS: Fifteen patients (10 male) used the system after approximately 5 minutes of instruction. Participants uploaded images on a median of 76% of eligible study days. The system captured and transmitted diagnostic quality images of the entire plantar surface of both feet, permitting clinical-management decisions on a remote basis. We monitored 12 active wounds and 39 pre-ulcerative lesions (five wounds and 13 pre-ulcerative lesions at study outset); we observed healing of seven wounds and reversal of 20 pre-ulcerative lesions. Participants rated the system as useful, empowering, and preferable to their previous methods of foot screening.
CONCLUSIONS: With minimal training, patients transmitted diagnostic-quality images from home on most days, allowing clinicians to review serial images. This system permits inexpensive home foot screening and monitoring of DFUs. Further studies are needed to determine whether it can reduce morbidity of DFUs and/or the associated cost of care. Artificial intelligence integration could improve scalability.
View on PubMed View on SourceJournal: Acta Biomaterialia
Diabetic foot ulcers (DFUs) are a devastating ailment for many diabetic patients with increasing prevalence and morbidity. The complex pathophysiology of DFU wound environments has made finding effective treatments difficult. Standard wound care treatments have limited efficacy in healing these types of chronic wounds. Topical biomaterial gels have been developed to implement novel treatment approaches to improve therapeutic effects and are advantageous due to their ease of application, tunability, and ability to improve therapeutic release characteristics. Here, we provide an updated, comprehensive review of novel topical biomaterial gels developed for treating chronic DFUs. This review will examine preclinical data for topical gel treatments in diabetic animal models and clinical applications, focusing on gels with protein/peptides, drug, cellular, herbal/antioxidant, and nano/microparticle approaches. STATEMENT OF SIGNIFICANCE: By 2050, 1 in 3 Americans will develop diabetes, and up to 34% of diabetic patients will develop a diabetic foot ulcer (DFU) in their lifetime. Current treatments for DFUs include debridement, infection control, maintaining a moist wound environment, and pressure offloading. Despite these interventions, a large number of DFUs fail to heal and are associated with a cost that exceeds $31 billion annually. Topical biomaterials have been developed to help target specific impairments associated with DFU with the goal to improve healing. A summary of these approaches is needed to help better understand the current state of the research. This review summarizes recent research and advances in topical biomaterials treatments for DFUs.
Copyright © 2021 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.
View on PubMed View on SourceJournal: International Immunopharmacology
AIM: The effectiveness of nanofibers containing human placenta-derived mesenchymal stem cells (hPDMSCs) plus platelet-rich plasma (PRP) for healing of diabetic foot ulcers (DFUs) was investigated.
METHODS: hPDMSCs were isolated from human donor placentas, and cultured in electrospun gelatin nanofibrous scaffolds (GNS). Twenty-eight patients with DFUs were randomized into three groups in a 12-week trial: (A) Treated with hPDMSCs; (B) Treated with hPDMSCs after coating the ulcer with PRP gel; (C) Control group received standard wound care. Wound area and pain freewalkingdistance were measured every 2 weeks.
RESULTS: Flow cytometry showed the expression of mesenchymal markers. SEM images and DAPI staining indicated significantly higher levels of hPDMSC proliferation on GNS after 3 and 7 days of culture. The MTS assay showed a significant increase in proliferation on GNS, compared to controls. Wound size reduction was 66% in group A, 71% in group B, and 36% in control group C. A significant difference in wound closure and pain-free walking distance was observed between groups A and B, compared to control group C (p < 0.05), but no difference between groups A and B. Biopsy of the implanted tissue showed the development of new capillary formation in groups A and B.
CONCLUSION: Implantation of hPDMSCs in GNS accelerated wound healing and improved clinical parameters in DFU patients.
Copyright © 2021. Published by Elsevier B.V.
View on PubMed View on SourceJournal: Open forum infectious diseases
Background: Diabetes is the leading cause of lower extremity nontraumatic amputation globally, and diabetic foot osteomyelitis (DFO) is usually the terminal event before limb loss. Although guidelines recommend percutaneous bone biopsy (PBB) for microbiological diagnosis of DFO in several common scenarios, it is unclear how frequently PBBs yield positive cultures and whether they cause harm or improve outcomes.
Methods: We searched the PubMed, EMBASE, and Cochrane Trials databases for articles in any language published up to December 31, 2019, reporting the frequency of culture-positive PBBs. We calculated the pooled proportion of culture-positive PBBs using a random-effects meta-analysis model and reported on PBB-related adverse events, DFO outcomes, and antibiotic adjustment based on PBB culture results where available.
Results: Among 861 articles, 11 studies met inclusion criteria and included 780 patients with 837 PBBs. Mean age ranged between 56.6 and 71.0 years old. The proportion of males ranged from 62% to 86%. All studies were longitudinal observational cohorts, and 10 were from Europe. The range of culture-positive PBBs was 56%-99%, and the pooled proportion of PBBs with a positive culture was 84% (95% confidence interval, 73%-91%). There was heterogeneity between studies and no consistency in definitions used to define adverse events. Impact of PBB on DFO outcomes or antibiotic management were seldom reported.
Conclusions: This meta-analysis suggests PBBs have a high yield of culture-positive results. However, this is an understudied topic, especially in low- and middle-income countries, and the current literature provides very limited data regarding procedure safety and impact on clinical outcomes or antibiotic management.
© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
View on PubMed View on Source
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NOTE: This is a controlled document. This document is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.
