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Diabetic Foot Ulcers - Clinical Guidelines and Quality Measures

Diabetic Foot Ulcers - Clinical Guidelines and Quality Measures

Diabetic Foot Ulcers - Clinical Guidelines and Quality Measures



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


  • 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]


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
2021 Guideline for Management of Patients With Lower-Extremity Wounds Due to Diabetes Mellitus and/or Neuropathic Disease: An Executive Summary
Wound, Ostomy and Continence Nurses Society, USA
Guideline (free)
2019 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, AustraliaGuideline (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)


Setting CMS Program Developed by Measure ID Title Year/ Description/ Benchmark (when available)
OutpatientQPP - MIPS (*)
US Wound Registry
Outcome measure: Adequate Off-loading of Diabetic Foot Ulcers at each visit, appropriate to location of ulcerPercentage 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, among eligible providers reporting this measure, per visit off-loading of DFUs is now achieved 59 % of the time
OutpatientQPP - MIPS (*)
US Wound RegistryCDR2Outcome 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.
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
OutpatientQPP - MIPS (*)
US Wound Registry and the Undersea and Hyperbaric Medical Society (UHMS)
CDR8Appropriate use of hyperbaric oxygen therapy for patients with diabetic foot ulcerPercent 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.[5]
OutpatientQPP - MIPS (*)
US Wound Registry 
CDR9Appropriate 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%.
OutpatientQPP - MIPS (*)
US Wound Registry and the Undersea and Hyperbaric Medical Society (UHMS)USWR16Outcome 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.
QPP - MIPS (*)
US Wound Registry 
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.

QPP - MIPS (*)
US Wound Registry 
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. Data from the USWR indicates that fewer than 10% of patients with chronic non-healing leg ulcers undergo any type of vascular assessment (ABI, transcutaneous oximetry or skin perfusion pressure) even at hospital based outpatient wound centers. 
QPP - MIPS (*)
US Wound Registry
Patient Reported Experience of Care: Wound Outcome
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.
OutpatientQPP - MIPS (*)
US Wound Registry
Assessment of Nutritionally At-Risk Patients for Malnutrition and Development of Nutrition Recommendations/Interventions by a Registered Dietitian Nutritionist
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.[6]
OutpatientQPP - MIPS (*)
US Wound Registry
Obtaining Preoperative Nutritional Recommendations from a Registered Dietitian Nutritionist (RDN) in Nutritionally At-Risk Surgical Patients
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.
OutpatientQPP - MIPS (*)
US Wound Registry, SCG Health
SCG2Outcome 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
OutpatientQPP - MIPS (*)
US Wound Registry, SCG Health
SCG3Outcome 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
OutpatientQPP - MIPS (*)
US Wound Registry, SCG Health
SCG5Improvement 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
OutpatientQPP - MIPS (*)
MedicareMIPS1Diabetes: Hemoglobin A1c Poor Control
Percentage of patients 18-75 years of age with diabetes who had hemoglobin A1c > 9.0% during the measurement period
QPP - MIPS (*)
MedicareMIPS 126Diabetes 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
OutpatientQPP - MIPS (*)
MedicareMIPS 127Diabetes 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
QPP - MIPS (*)
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

QPP - MIPS (*)
MedicareMIPS 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.



Standard of Care: Foundations for Wound Management, The Treatment of Impaired Wound Healing in Diabetes: Looking among Old Drugs., 2020 Apr 01
Journal: 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.

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Developing a Limb Preservation Program: Our Journey to Excellence, 2021 Guideline for Management of Patients With Lower-Extremity Wounds Due to Diabetes Mellitus and/or Neuropathic Disease: An Executive Summary., 2022 Jun 01
Journal: 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.

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Validation of the Fast-Track Model: A Simple Tool to Assess the Severity of Diabetic Foot Ulcers., 2023 Jan 18
Journal: 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.

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Advances in the Clinical Application of Platelet-Rich Plasma in the Foot and Ankle: A Review., 2023 Jan 28
Journal: 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.

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Adherence and Wearing Time of Prescribed Footwear among People at Risk of Diabetes-Related Foot Ulcers: Which Measure to Use?, 2023 Feb 02
Journal: 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.

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Presurgical perspective and postsurgical evaluation of the diabetic foot., 2022 Dec
Journal: 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.

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Impact of topical oxygen therapy on diabetic foot ulcer healing rates: a systematic review., 2021 Oct 02
Journal: 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.

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A systematic review and meta-analysis of efficacy and safety of negative pressure wound therapy in the treatment of diabetic foot ulcer., 2021 Oct
Journal: 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.

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Heparin and Related Substances for Treating Diabetic Foot Ulcers: A Systematic Review and Meta-Analysis., 2022 Feb 24
Journal: 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.

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Honey dressings for diabetic foot ulcers: overview of evidence-based practice for novice researchers., 2020 Sep 01
Journal: 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.

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Reduced Hospitalizations and Amputations in Patients with Diabetic Foot Ulcers Treated with Cyclical Pressurized Topical Wound Oxygen Therapy: Real-World Outcomes., 2022 Dec
Journal: 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.

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Human amnion chorion membrane allografts in the treatment of chronic diabetic foot ulcers: A literature review., 2021 Apr 01
Journal: 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.

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A pilot feasibility study of non-cultured autologous skin cell suspension for healing diabetic foot ulcers., 2020 Nov
Journal: 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.

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Topical Administration of Teucrium polium on Diabetic Foot Ulcers Accelerates Healing: A Placebo-Controlled Randomized Clinical Study., 2021 Nov 01
Journal: 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.

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Initial Clinical Experience with a Simple, Home System for Early Detection and Monitoring of Diabetic Foot Ulcers: The Foot Selfie., 2023 Jan
Journal: 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.

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Topical gel-based biomaterials for the treatment of diabetic foot ulcers., 2021 Oct 30
Journal: 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. 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. Published by Elsevier Ltd.

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Improved wound healing of diabetic foot ulcers using human placenta-derived mesenchymal stem cells in gelatin electrospun nanofibrous scaffolds plus a platelet-rich plasma gel: A randomized clinical trial., 2021 Oct 28
Journal: 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.

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Percutaneous Bone Biopsy for Diabetic Foot Osteomyelitis: A Systematic Review and Meta-Analysis., 2020 Oct
Journal: 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.

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