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Arterial Ulcers - Guidelines and Quality Measures

Arterial Ulcers - Guidelines and Quality Measures

Arterial Ulcers - Guidelines and Quality Measures


    This topic provides a list of Guidelines, Quality Measures and other resources on Arterial Ulcers. See topic "Arterial Ulcers - Introduction and Assessment" for a review and framework for assessment of arterial ulcers, including epidemiology, risk factors, etiology, pathophysiology, history, physical examination, diagnosis, differential diagnoses, documentation and ICD-10 coding. For management of arterial ulcers see " Arterial Ulcer - Treatment", and "Arterial ulcer - Surgical Treatment". For patient education, see topic "Patient Education - Arterial Ulcer".


    Below is a list of the some of the most recent evidence-based guidelines on arterial ulcers, and associated vascular conditions (e.g., peripheral artery disease, chronic limb-threatening ischemia, acute limb ischemia) 

    Evidence-based guideline, YearPublishing Organization, Country or Region
    Arterial Ulcers

    2024 TSOC/TSPS Joint Consensus: Strategies for Advanced Vascular Wound Management in Arterial and Venous Diseases, 2024
    Taiwan Society of Cardiology (TSOC) and Taiwan Society of Plastic Surgery (TSPS)
    Guideline (Free)
    Wound healing society 2014 update on guidelines for arterial ulcers, 2014
    Wound Healing Society, USA
    Guideline (Free)
    2014 Guideline for Management of Wounds in Patients With Lower-Extremity Arterial Disease (LEAD): An Executive Summary, 2014
    Wound, Ostomy and Continence Nurses Society, USA
    Guideline (Paid)
    Associated Vascular Conditions

    The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes and a foot ulcer, 2023
    Guideline (Free)
    Australian guideline on diagnosis and management of peripheral artery disease: part of the 2021 Australian evidence-based guidelines for diabetes-related foot disease, 2022
    National content experts
    Guideline (Free)
    Editor's Choice - European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischaemia, 2020
    European Society for Vascular Surgery, Europe
    Guideline (Free)
    Global vascular guidelines on the management of chronic limb-threatening ischemia, 2019
    European Society for Vascular Surgery, Society for Vascular Surgery, World Federation of Vascular Societies, Global
    Guideline (Free)
    Editor's Choice - 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in Collaboration With the European Society for Vascular Surgery (ESVS), 2017
    European Society of Cardiology, European Society for Vascular Surgery, Europe
    Guideline (Free)
    2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary, 2016
    American College of Cardiology, American Heart Association, USA
    Guideline (Free)


    Relevant Quality Measures are listed below. Diabetic foot ulcer quality measures are also included, as arterial ulcers frequently present with mixed etiology (ischemic and neuropathic). For CMS MIPS measures, benchmarks are available on the CMS Quality Payment Program Measures Benchmarks

    SettingCMS ProgramDeveloped byMeasure IDTitleYear/ Description/ Benchmark (when available)
    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. 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.[1] 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.[2]
    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.[3] Since 2018, the average performance rate has been 10% or less.[4] 
    QPP - MIPS (*)
    US Wound Registry 
    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.

    OutpatientQPP-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.[5]
    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. 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.[6]
    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 (*)
    American Podiatric Medical AssociationMIPS 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 (*)
    American Podiatric Medical AssociationMIPS 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

    MIPS (*)
    National Committee for Quality Assurance
    MIPS 155Falls: 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.
    OutpatientQPP - MIPS (*)Registry Clearinghouse in Collaboration with Ohio Foot and Ankle Medical Association
    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. 
    OutpatientQPP - MIPS (*)
    Registry Clearinghouse in Collaboration with Ohio Foot and Ankle Medical Association
    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.[7]

    SettingCMS ProgramDeveloped byMeasure IDTitleYear/ Description/ Benchmark (when available)
    QPP - MIPS (*)
    US Wound Registry
    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.
    QPP - MIPS (*)
    US Wound Registry
    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.[8]
    QPP - MIPS (*)
    US Wound Registry
    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. 
    QPP - MIPS (*)
    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 retired/deleted.


    Chronic Limb-Threatening Ischemia and the Need for Revascularization., 2023 Apr 04
    Journal: Journal of clinical medicine

    BACKGROUND: Patients presenting with critical limb-threatening ischemia (CLTI) have been increasing in number over the years. They represent a high-risk population, especially in terms of major amputation and mortality. Despite multiple guidelines concerning their management, it continues to be challenging. Decision-making between surgical and endovascular procedures should be well established, but there is still a lack of consensus concerning the best treatment strategy. The aim of this manuscript is to offer an overview of the contemporary management of CLTI patients, with a focus on the concept that evidence-based revascularization (EBR) could help surgeons to provide more appropriate treatment, avoiding improper procedures, as well as too-high-risk ones.

    METHODS: We performed a search on MEDLINE, Embase, and Scopus from 1 January 1995 to 31 December 2022 and reviewed Global and ESVS Guidelines. A total of 150 articles were screened, but only those of high quality were considered and included in a narrative synthesis.

    RESULTS: Global Vascular Guidelines have improved and standardized the way to classify and manage CLTI patients with evidence-based revascularization (EBR). Nevertheless, considering that not all patients are suitable for revascularization, a key strategy could be to stratify unfit patients by considering both clinical and non-clinical risk factors, in accordance with the concept of individual residual risk for every patient. The recent BEST-CLI trial established the superiority of autologous vein bypass graft over endovascular therapy for the revascularization of CLTI patients. However, no-option CLTI patients still represent a critical issue.

    CONCLUSIONS: The surgeon's experience and skillfulness are the cornerstones of treatment and of a multidisciplinary approach. The recent BEST-CLI trial established that open surgical peripheral vascular surgery could guarantee better outcomes than the less invasive endovascular approach.

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    Cigarette Smoking: Health Risks and How to Quit (PDQ®): Health Professional Version, 2020

    This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the prevention and cessation of cigarette smoking and the control of tobacco use. It is intended as a resource to inform and assist clinicians who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions. This summary is reviewed regularly and updated as necessary by the PDQ Screening and Prevention Editorial Board, which is editorially independent of the National Cancer Institute (NCI). The summary reflects an independent review of the literature and does not represent a policy statement of NCI or the National Institutes of Health (NIH).

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    Systematic literature review of randomized trials comparing antithrombotic therapy following revascularization procedures in patients with peripheral artery disease., 2020 Jul 08
    Journal: Angiology

    A systematic literature review was conducted to identify and summarize the clinical efficacy and safety of available antithrombotic therapies after peripheral endovascular or surgical revascularization in patients with peripheral artery disease (PAD). Five databases were searched using free-text and Emtree/Mesh terms for PAD, randomized controlled trials (RCTs), and antithrombotic therapies of interest (ie, single antiplatelet therapy, dual antiplatelet therapy, and vitamin K antagonists). Randomized controlled trials were eligible for inclusion if they assessed the risk of thrombotic events (ie, myocardial infarction, ischemic stroke, cardiovascular death, limb ischemia, or limb amputation) or safety profile (ie, minor, moderate, major, or fatal bleeding events) after revascularization. In total, 16 RCTs were identified. Only a few studies reported on treatment effects of the investigated therapies. Myocardial infarction, ischemic stroke, cardiovascular death, and amputation were reported in up to 2.3%, 2.3%, 5.6%, and 7.3% of patients, respectively. Bleeding events were observed in up to 8.4% (major) and 1.5% (fatal) of patients. Despite available treatments, patients with PAD undergoing revascularization remain at risk of thrombotic events. There is a need for new treatments that will help to optimize care for patients with symptomatic PAD undergoing revascularization.

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    Peripheral artery disease in the lower limbs: The importance of secondary risk prevention for improved long-term prognosis., 2020
    Journal: Australian journal of general practice

    BACKGROUND: Patients with lower limb peripheral artery disease (PAD) are at high risk of cardiovascular mortality and morbidity along with limb loss. PAD is underdiagnosed in the community and presents a missed opportunity to prescribe evidence-based secondary prevention therapy.

    OBJECTIVE: The aim of this article is to summarise key updates in the management of patients with PAD, with particular reference to newly published guidelines.

    DISCUSSION: PAD continues to be a major contributor to the mortality and morbidity of patients with atherosclerosis in Australia. For patients with chronic limb-threatening ischaemia, revascularisation remains the mainstay of limb salvage, and expedited access to vascular surgery assessment is necessary. Both prescription of, and adherence to, evidence-based secondary prevention therapy is low. A greater emphasis on cardiovascular risk factor modification for all patients with PAD is required to improve long-term outcomes. General practitioners and vascular surgeons can work collaboratively to provide patient-centred, effective care to patients with PAD.

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    Vascular regeneration in peripheral artery disease., 2020 Jul
    Journal: Arteriosclerosis, Thrombosis, and Vascular Biology

    Peripheral artery disease is a common disorder and a major cause of morbidity and mortality worldwide. Therapy is directed at reducing the risk of major adverse cardiovascular events and at ameliorating symptoms. Medical therapy is effective at reducing the incidence of myocardial infarction and stroke to which these patients are prone but is inadequate in relieving limb-related symptoms, such as intermittent claudication, rest pain, and ischemic ulceration. Limb-related morbidity is best addressed with surgical and endovascular interventions that restore perfusion. Current medical therapies have only modest effects on limb blood flow. Accordingly, there is an opportunity to develop medical approaches to restore limb perfusion. Vascular regeneration to enhance limb blood flow includes methods to enhance angiogenesis, arteriogenesis, and vasculogenesis using angiogenic cytokines and cell therapies. We review the molecular mechanisms of these processes; briefly discuss what we have learned from the clinical trials of angiogenic and cell therapies; and conclude with an overview of a potential new approach based upon transdifferentiation to enhance vascular regeneration in peripheral artery disease.

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    Platelet-rich fibrin and concentrated growth factors as novel platelet concentrates for chronic hard-to-heal skin ulcers: a systematic review and Meta-analysis of randomized controlled trials., 2022 Mar
    Journal: The Journal of Dermatological Treatment

    BACKGROUND: This study aimed to determine superior outcomes of platelet-rich fibrin and concentrated growth factors dressings in chronic hard-to-heal skin ulcers.

    METHODS: A search in PubMed, EMBASE, Cochrane Library and CINAHL(EBSCO) was performed for randomized controlled trials comparing platelet-rich fibrin or concentrated growth factors dressings to standard wound care in chronic hard-to-heal skin ulcers. Primary outcome was the number of ulcers completely healed. Secondary outcomes were percentage of ulcers area reduction and complications. Dichotomous and continuous results were pooled in risk difference and mean difference respectively, with a 95% confidence interval (CI).

    RESULTS: Eight studies with 578 patients were included. The number of ulcers completely healed in platelet-rich fibrin was significantly higher than in control group, during the fourth week of follow-up (risk difference, 0.48; 95% CI, 0.31-0.66; p <  .00001) and at the end of follow-up (risk difference, 0.17; 95% CI, 0.08-0.26; p = .0003). The pooled result between concentrated growth factors and control group was inconclusive due to two few studies included.

    CONCLUSIONS: Platelet-rich fibrin is safe and promising to promote healing of chronic hard-to-heal skin ulcers versus standard wound care. Further studies are warranted to evaluate the roles of concentrated growth factors.

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    Nutritional considerations for peripheral arterial disease: A narrative review., 2019 May 29
    Journal: Nutrients

    Those with peripheral arterial disease (PAD) require important considerations with respect to food and nutrition, owing to advanced age, poor diet behaviours and immobility associated with the disease process and co-morbid state. These considerations, coupled with the economic effectiveness of medical nutrition therapy, mandate that dietetic care plays a vital role in the management of PAD. Despite this, optimising dietetic care in PAD remains poorly understood. This narrative review considers the role of medical nutrition therapy in every stage of the PAD process, ranging from the onset and initiation of disease to well established and advanced disease. In each case, the potential benefits of traditional and novel medical nutrition therapy are discussed.

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    Lower extremity peripheral artery disease: diagnosis and treatment., 2019 Mar 15
    Journal: American Family Physician

    Lower extremity peripheral artery disease (PAD) affects 12% to 20% of Americans 60 years and older. The most significant risk factors for PAD are hyperlipidemia, hypertension, diabetes mellitus, chronic kidney disease, and smoking; the presence of three or more factors confers a 10-fold increase in PAD risk. Intermittent claudication is the hallmark of atherosclerotic lower extremity PAD, but only about 10% of patients with PAD experience intermittent claudication. A variety of leg symptoms that differ from classic claudication affects 50% of patients, and 40% have no leg symptoms at all. Current guidelines recommend resting ankle-brachial index (ABI) testing for patients with history or examination findings suggesting PAD. Patients with symptoms of PAD but a normal resting ABI can be further evaluated with exercise ABI testing. Routine ABI screening for those not at increased risk of PAD is not recommended. Treatment of PAD includes lifestyle modifications-including smoking cessation and supervised exercise therapy-plus secondary prevention medications, including antiplatelet therapy, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and statins. Surgical revascularization should be considered for patients with lifestyle-limiting claudication who have an inadequate response to the aforementioned therapies. Patients with acute or limb-threatening limb ischemia should be referred immediately to a vascular surgeon.

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    Peripheral artery disease: past, present, and future., 2019 Oct
    Journal: The American Journal of Medicine

    Peripheral artery disease is a prevalent but underdiagnosed manifestation of atherosclerosis. There is insufficient awareness of its clinical manifestations, including intermittent claudication and critical limb ischemia and of its risk of adverse cardiovascular and limb outcomes. In addition, our inadequate knowledge of its pathophysiology has also limited the development of effective treatments, particularly in the presence of critical limb ischemia. This review aims to highlight essential elements of the epidemiology and pathophysiology of peripheral artery disease, bring attention to the often-atypical manifestations of occlusive arterial disease of the lower extremity, increase awareness of critical limb ischemia, briefly describe the diagnostic role of the ankle brachial index, and go over the contemporary management of peripheral artery disease. An emphasis is placed on evidence-based medical treatments to improve symptoms and quality of life and to reduce the risk of cardiovascular and limb events in these patients, including supervised exercise training, smoking cessation, antagonism of the renin-angiotensin system, lipid-lowering, antiplatelet, and antithrombotic therapies.

    Copyright © 2019 Elsevier Inc. All rights reserved.

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    Editor's Choice - European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischaemia., 2020 Feb
    Journal: European Journal of Vascular and Endovascular Surgery

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    New vascular guidelines for treating acute and chronic limb-threatening ischaemia., 2020 Feb
    Journal: The British Journal of Surgery

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    Evidence-Based Medical Management of Peripheral Artery Disease., 2020 Mar
    Journal: Arteriosclerosis, Thrombosis, and Vascular Biology

    Peripheral artery disease is an atherosclerotic disease of the lower extremities associated with high cardiovascular mortality. Management of this condition may include lifestyle modifications, medical management, endovascular repair, or surgery. The medical approach to peripheral artery disease is multifaceted and includes cholesterol reduction, antiplatelet therapy, anticoagulation, peripheral vasodilators, blood pressure management, exercise therapy, and smoking cessation. Adherence to this regimen can reduce limb-related complications like critical limb ischemia and amputation, as well as systemic complications of atherosclerosis like stroke and myocardial infarction. Relative to coronary artery disease, peripheral artery disease is an undertreated condition. In this article, we explore the evidence behind medical therapies for the management of peripheral artery disease.

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    Dressings and topical agents for arterial leg ulcers., 2020 Jan 20
    Journal: Cochrane Database of Systematic Reviews

    BACKGROUND: It is estimated that up to 1% of people in high-income countries suffer from a leg ulcer at some time in their life. The majority of leg ulcers are associated with circulation problems; poor blood return in the veins causes venous ulcers (around 70% of ulcers) and poor blood supply to the legs causes arterial ulcers (around 22% of ulcers). Treatment of arterial leg ulcers is directed towards correcting poor arterial blood supply, for example by correcting arterial blockages (either surgically or pharmaceutically). If the blood supply has been restored, these arterial ulcers can heal following principles of good wound-care. Dressings and topical agents make up a part of good wound-care for arterial ulcers, but there are many products available, and it is unclear what impact these have on ulcer healing. This is the third update of a review first published in 2003.

    OBJECTIVES: To determine whether topical agents and wound dressings affect healing in arterial ulcers. To compare healing rates and patient-centred outcomes between wound dressings and topical agents.

    SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature and Allied and Complementary Medicine databases, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 28 January 2019.

    SELECTION CRITERIA: Randomised controlled trials (RCTs), or controlled clinical trials (CCTs) evaluating dressings and topical agents in the treatment of arterial leg ulcers were eligible for inclusion. We included participants with arterial leg ulcers irrespective of method of diagnosis. Trials that included participants with mixed arterio-venous disease and diabetes were eligible for inclusion if they presented results separately for the different groups. All wound dressings and topical agents were eligible for inclusion in this review. We excluded trials which did not report on at least one of the primary outcomes (time to healing, proportion completely healed, or change in ulcer area).

    DATA COLLECTION AND ANALYSIS: Two review authors independently extracted information on the participants' characteristics, the interventions, and outcomes using a standardised data extraction form. Review authors resolved any disagreements through discussion. We presented the data narratively due to differences in the included trials. We used GRADE to assess the certainty of the evidence.

    MAIN RESULTS: Two trials met the inclusion criteria. One compared 2% ketanserin ointment in polyethylene glycol (PEG) with PEG alone, used twice a day by 40 participants with arterial leg ulcers, for eight weeks or until healing, whichever was sooner. One compared topical application of blood-derived concentrated growth factor (CGF) with standard dressing (polyurethane film or foam); both applied weekly for six weeks by 61 participants with non-healing ulcers (venous, diabetic arterial, neuropathic, traumatic, or vasculitic). Both trials were small, reported results inadequately, and were of low methodological quality. Short follow-up times (six and eight weeks) meant it would be difficult to capture sufficient healing events to allow us to make comparisons between treatments. One trial demonstrated accelerated wound healing in the ketanserin group compared with the control group. In the trial that compared CGF with standard dressings, the number of participants with diabetic arterial ulcers were only reported in the CGF group (9/31), and the number of participants with diabetic arterial ulcers and their data were not reported separately for the standard dressing group. In the CGF group, 66.6% (6/9) of diabetic arterial ulcers showed more than a 50% decrease in ulcer size compared to 6.7% (2/30) of non-healing ulcers treated with standard dressing. We assessed this as very-low certainty evidence due to the small number of studies and arterial ulcer participants, inadequate reporting of methodology and data, and short follow-up period. Only one trial reported side effects (complications), stating that no participant experienced these during follow-up (six weeks, low-certainty evidence). It should also be noted that ketanserin is not licensed in all countries for use in humans. Neither study reported time to ulcer healing, patient satisfaction or quality of life.

    AUTHORS' CONCLUSIONS: There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers.

    Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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    1. Fife CE, Eckert KA, Carter MJ et al. Publicly Reported Wound Healing Rates: The Fantasy and the Reality. Advances in wound care. 2018;volume 7(3):77-94.
    2. US Wound Registry. Quality Measure CDR2: Diabetic Foot Ulcer (DFU) Healing or Closure . 2021;.
    3. Margolis, David J; Gupta, Jayanta; Hoffstad, Ole; Papdopoulos, Maryte; Glick, Henry A; Thom, Stephen R; Mitra, Nandita et al. Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and the prevention of amputation: a cohort study. Diabetes Care. 2013;volume 36(7):1961-1966.
    4. US Wound Registry. Quality Measure CDR8: Appropriate Use of Hyperbaric Oxygen Therapy (HBOT) for Patients with Diabetic Foot Ulcers . 2021;.
    5. US Wound Registry. Quality Measure USWR29: Adequate Off-loading of Diabetic Foot Ulcers (DFUs) Performed at Each Visit, Appropriate to Location of Ulcer . 2021;.
    6. US Wound Registry. Quality Measure USWR30: Non Invasive Arterial Assessment of Patients with Lower Extremity Wounds or Ulcers for Determination of Healing Potential . 2021;.
    7. Sherry CL, Sauer AC, Thrush KE et al. Assessment of the Nutrition Care Process in US Hospitals Using a Web-Based Tool Demonstrates the Need for Quality Improvement in Malnutrition Diagnosis and Discharge Care. Current developments in nutrition. 2017;volume 1(11):e001297.
    Topic 761 Version 3.0


    Evidence-based review on arterial ulcer. Framework for assessment of patients with arterial ulcers. Includes concise abstract and comprehensive resources on the condition (e.g. epidemiology, risk factors, etiology, pathophysiology, history, physical examination, diagnosis, differential diagnoses, documentation and ICD-10 coding)

    Concise Algorithm for Assessment of Arterial Ulcer for use at point-of-care. Comprehensive topic including epidemiology, risk factors, etiology, pathophysiology, history, physical examination, diagnosis, differential diagnoses, documentation and ICD-10 coding. Free Abstract Summary

    This topic covers surgical management of arterial ulcers (AUs) with focus on surgical indications and selection criteria.