Maggot Debridement Therapy for Chronic Leg and Foot Ulcers: A Review of Randomized Controlled Trials.

OBJECTIVE: To critically analyze the existing randomized controlled trials (RCTs) on the clinical, economic, and psychological implications of maggot debridement therapy (MDT). DATA SOURCES: An exhaustive literature search for English-language publications was conducted using MEDLINE, EMBASE, and PubMed. STUDY SELECTION: Keywords used for the search were based on the PICO (Population, Intervention, Comparison, Outcome) framework. The titles, abstracts, and relevant full-text articles were screened. Seven RCTs were selected after applying the inclusion and exclusion criteria. DATA EXTRACTION: Data pertaining to the primary and secondary outcomes of each study were extracted. DATA SYNTHESIS: The data extracted were evaluated and categorized into clinical, economic, and psychological outcomes pertaining to MDT. A judicious evaluation of these outcomes was made, and the following conclusions were drawn. CONCLUSIONS: There exists heterogeneity in the extant RCTs, but MDT appears to be effective for a quick early debridement. For diabetic foot ulcers, MDT improves debridement, controls infection, and enhances wound healing. In chronic peripheral vascular disease ulcers, it aids in early debridement, but the final outcome is equivocal. Further robust integrated health economic and parallel qualitative assessment studies are recommended to understand the cost-effectiveness and patient acceptability and experience.

Lower Extremity Ulcers.

Lower extremity ulcerations contribute to significant morbidity and economic burden globally. Chronic wounds, or those that do not progress through healing in a timely manner, are estimated to affect 6.5 million people in the United States alone causing, significant morbidity and economic burden of at least an estimated $25 billion annually. Owing to the aging population and increasing rates of obesity and diabetes mellitus globally, chronic lower extremity ulcers are predicted to increase. Here, we explore the pathophysiology, diagnosis, and management of the most (and least) commonly seen lower extremity ulcers.

Vascular assessment in venous leg ulcer diagnostics and management in Australian primary care: Clinician experiences.

AIM: In this article, we focus on primary health clinicians' experiences of vascular assessment in venous leg ulcer (VLU) diagnostics and management, including ankle brachial pressure index (ABPI) measurements using Doppler ultrasonography. METHODS: We conducted semi-structured face-to-face and telephone interviews with general practitioners [15] and practice nurses [20] from primary health care settings in Australia. Twenty-one participants were recruited from practices located in Melbourne metropolitan settings and 14 from rural Victoria. We used the theory driven thematic analysis as a method of data analysis. The Theoretical Domains Framework informed this analysis. RESULTS: Five domains were identified as relevant, including Environmental Context and Resources, Motivation and Goals, Skills, Knowledge, and Beliefs about Capabilities. Although the Australian and New Zealand clinical practice guideline for prevention and management of venous leg ulcers recommend that vascular assessment is conducted for all patients with suspected VLUs, findings from our study indicate vascular assessments are not routinely performed in many primary care settings. Our study also found that a lack of awareness of clinical practice guidelines among clinicians might be one of the main issues for not following the latest clinical recommendations for vascular assessment in venous leg ulcer diagnostics and wound management practice. CONCLUSION: We recommend development of theory-informed interventions for clinicians in primary health care settings to optimise VLU management and healing outcomes for patients with VLUs. Implementation and evaluation of these interventions have the potential to reduce the evidence-practice gap in VLU management and optimise healing outcomes.

LIMPRINT in Australia.

Background and Study Objective: Australia was one of nine participating countries in the epidemiology Phase II Lymphoedema Impact and Prevalence - International (LIMPRINT) project to determine the number of people with chronic edema (CO) in local health services. Methods and Results: Data collection occurred through questionnaire-based interviews and clinical assessment with provided LIMPRINT tools. Four different types of services across three states in Australia participated. A total of 222 adults participated with an age range from 22 to 102 years, and 60% were female. Site 1 included three residential care facilities (54% of participants had swelling), site 2 was community-delivered aged care services (24% of participants had swelling), site 3 was a hospital setting (facility-based prevalence study; 28% of participants had swelling), and site 4 was a wound treatment center (specific patient population; 100% of participants had swelling). Of those with CO or secondary lymphedema, 93% were not related to cancer, the lower limbs were affected in 51% of cases, and 18% of participants with swelling reported one or more episodes of cellulitis in the previous year. Wounds were identified in 47% (n = 105) of all participants with more than half of those with wounds coming from the dedicated wound clinic. Leg/foot ulcer was the most common type of wound (65%, n = 68). Conclusions: Distances between services, lack of specialized services, and various state funding models contribute to inequities in CO treatment. Understanding the high number of noncancer-related CO presentations will assist health services to provide timely effective care and improve referral pathways.

Lymphedema Impact and Prevalence International Study: The Canadian Data.

Background: Chronic edema/lymphedema is defined as edema present for more than 3 months. It is underrecognized and undertreated. The International Lymphedema Framework developed an international study, Lymphedema Impact and Prevalence International (LIMPRINT), to estimate the prevalence and impact of chronic edema in heterogeneous populations. Canada participated in this study. Methods and Results: Participants were recruited from an outpatient chronic wound management clinic. At a study visit, the following tools were administered: The Core Tool, Demographics and Disability assessment (WHODAS 2.0), Quality-of-life assessment (LYMQOL + EQ-5D), Details of swelling, Wound assessment, and Cancer. Data were entered into an international database (Clindex), and country-specific data were analyzed. Sixty-eight subjects were enrolled. Fifty-seven percent were males and 43% females. More than 90% were older than 45 years. Only 7.35% had primary lymphedema. Most had lower extremity edema (65 of 68). Over half (47.06%) were morbidly obese with body mass index of >40. The most common underlying condition was venous disease. Only 8 of 68 had a history of cancer. While 72.06% had a history of cellulitis, only 10.2% had been hospitalized in the past year. 39.71% had an open wound. More than 75% had received multilayer bandaging, compression garments, wound dressings, and extensive counseling. Few had received manual lymphatic drainage, which is not funded. Disability was less than expected. Conclusion: Chronic edema/lymphedema is an underrecognized condition. These data and the wider LIMPRINT study are important tools to advocate for wider recognition and funding of treatment by health care systems.

Estimating the Clinical Outcomes and Cost Differences Between Standard Care With and Without Cadexomer Iodine in the Management of Chronic Venous Leg Ulcers Using a Markov Model.

Chronic venous leg ulcers (VLUs) affect up to 1% of the adult population in the developed world and present a significant financial and resource burden to health care systems. Cadexomer iodine (CI) is an antimicrobial dressing indicated for use in chronic exuding wounds. The aim of this study was to estimate the cost utility of using CI + standard care (SC) - ie, high compression multicomponent bandaging including debridement - compared with SC alone in the management of chronic (>6 months' duration) VLUs from a payer's perspective. A Markov model was constructed to evaluate the cost and clinical benefits (healing and decreased infection rates) of the 2 treatment modalities over a 1-year period using data from 4 randomized, controlled clinical studies (RCTs) included in a recent Cochrane review and cost data from a recently published economic evaluation of VLUs. Costs were calculated using 2014 United States dollars; wound outcomes in- cluded complete healing in 212 patients reported in the Cochrane meta-analysis and quality-adjusted life years (QALYs), with utility values obtained from 200 patients with VLUs calculated using standard gamble. Treatment with CI over 1 year was $7,259 compared to $7,901 for SC. This resulted in a cost savings of $643/patient in favor of CI compared with SC. More patients treated with CI (61%) had their wounds healed compared to 54% treated with SC. Furthermore, patients treated with CI+SC experienced 6 additional ulcer-free weeks compared to persons treated with SC alone (ie, 25 ulcer- free weeks compared to 19 ulcer-free weeks, respectively). Overall, CI resulted in 0.03 more QALYs (ie, 0.86 QALYs compared to 0.83 for SC). The use of CI in addition to SC compared to SC alone over 52 weeks resulted in more wounds healed and more QALYs along with a decrease of overall costs The results of this study suggest CI is cost effective com- pared to SC alone in the management of patients with chronic VLUs. Prospective, controlled clinical studies are needed to elucidate the effect and cost effectiveness of CI on VLUs with and without signs of infection as compared to SC, other antiseptics, and more advanced topical treatment modalities.

Use of a fluorescence angiography system in assessment of lower extremity ulcers in patients with peripheral arterial disease: A review and a look forward.

The prevalence of chronic wounds is sharply rising throughout the world due to an aging population and increases in the incidence of obesity, diabetes, and cardiovascular diseases. People with diabetes, hypertension, and hyperlipidemia are at increased risk for developing peripheral arterial disease (PAD). PAD affects 8 to 12 million people over the age of 40 years in the United States and it is a major contributing factor to the development of lower extremity ulcers. Although a number of noninvasive diagnostic tests are available to detect PAD in lower extremities, they have several clinical limitations. In this review, current understanding of the pathophysiology of commonly seen lower extremity ulcers is described and vascular assessments typically used in practice are evaluated. In addition, application of the LUNA Fluorescence Angiography System (Novadaq, Bonita Springs, FL) for the screening and treatment of complex nonhealing wounds in patients with PAD is discussed.

Wound healing and cost-saving benefits of combining negative-pressure wound therapy with silver.

A 20-patient case series is presented, demonstrating the incorporation of a silver antimicrobial negative-pressure dressing and a negative-pressure wound therapy device for improved healing outcomes, decreased nursing time expenditure, and decreased cost expenditure.

Quality of life and leg ulceration from the patient's perspective.

Chronic leg ulceration can have a profound impact on a patient's quality of life. Studies have shown that pain, and general interference with normal activities of living, are the major themes emerging which are often not dealt with in a consistent manner by healthcare professionals. A literature review of this subject shows that although a number of studies have been carried out on quality of life related to chronic leg ulceration, there is little evidence that these findings are being addressed in daily management of these often complex leg ulcer patients. The aim of this article is to examine the research relating to quality of life and leg ulceration, and to attempt to determine what the most important issues are from the patient's perspective, in an effort to improve the way nurses manage their care.

The measurement of leg ulcer pain: identification and appraisal of pain assessment tools.

OBJECTIVE: To identify and compare the psychometric, clinical sensibility, and pain-specific properties of leg ulcer pain assessment tools for use as a guide for clinicians and researchers. DESIGN: Pain assessment tools were selected for appraisal based on 4 inclusion criteria: (1) designed specifically to measure either quality and/or intensity of pain, (2) used in at least 2 different diseases and/or pain-inducing interventions in adults, (3) generic, and (4) patient self-reporting. The tools were appraised against psychometric properties, clinical sensibility attributes, and pain-specific issues. Two reviewers independently reviewed each abstract, with a third reviewer resolving any disagreements. Then the first 2 reviewers independently assessed the selected tools using the predetermined appraisal criteria. RESULTS: Of 54 identified pain assessment tools, 5 (the pain ruler, the numerical rating scale, the visual analogue scale, the verbal descriptor scale, and the short-form McGill Pain Questionnaire) met the inclusion criteria. Each tool met the appraisal criteria to varying degrees. CONCLUSIONS: The use of a pain assessment tool to measure leg ulcer pain is recommended. Clinicians must decide independently which factors are most important when selecting a tool. Although a specific pain assessment approach cannot yet be recommended, a 2-step pain assessment process is most practical. To optimize pain management, further study is needed to ensure that leg ulcer pain is accurately and reliably assessed.

Randomized trial of four-layer and two-layer bandage systems in the management of chronic venous ulceration.

To compare a four-layer bandage system with a two-layer system in the management of chronic venous leg ulceration, a prospective randomized open parallel groups trial was undertaken. In total, 112 patients newly presenting to leg ulcer services with chronic leg ulceration, screened to exclude the presence of arterial disease (ankle brachial pressure index <0.8) and causes of ulceration other than venous disease, were entered into the trial. Patients were randomized to receive either four-layer (Profore) or two-layer (Surepress) high-compression elastic bandage systems. In all, 109 out of 112 patients had at least one follow-up. After 24 weeks, 50 out of 57 (88%) patients randomized to the four-layer bandage system with follow-up had ulcer closure (full epithelialization) compared with 40 out of 52 (77%) on the two-layer bandage, hazard ratio = 1.18 (95% confidence interval 0.69-2.02), p = 0.55. After 12 weeks, 40 out of 57 (70%) patients randomized to the four-layer bandage system with follow-up had ulcer closure compared with 30 out of 52 (58%) on the two-layer bandage, odds ratio = 4.23 (95% confidence interval 1.29-13.86), p = 0.02. Withdrawal rates were significantly greater on the two-layer bandage (30 out of 54; 56%) compared with the four-layer bandage system (8 out of 58; 14%), p < 0.001, and the number of patients with at least one device-related adverse incident was significantly greater on the two-layer bandaging system (15 out of 54; 28%) compared with four-layer bandaging (5 out of 54; 9%), p = 0.01. The higher mean cost of treatment in the two-layer bandaging system arm over 24 weeks ($1374 [ pound 916] vs. $1314 [ pound 876]) was explained by the increased mean number of bandage changes (1.5 vs. 1.1 per week) with the two-layer system. In conclusion, the four-layer bandage offers advantages over the two-layer bandage in terms of reduced withdrawal from treatment, fewer adverse incidents, and lower treatment cost.

[Epidemiology and physiopathology of chronic venous leg diseases]. / Epidémiologie et physiopathologie des maladies veineuses chroniques des membres inférieurs.

Chronic venous disorders of the lower limbs include a wide range of clinical manifestations involving more than one half of the population in the industrial countries. Varicose veins have a multifactorial origin, linked to ageing, environment (life habits, pregnancies...) and heredity. Their development is related to an increased distensibility of the venous wall and to haemodynamic dysfunction secondary to valvular incompetence. Cutaneous trophic changes and leg ulcers are the final result of severe primary varicose disease or post-thrombotic disease. Elder people are mostly concerned. Skin disease results from ambulatory venous hyperpressure due to several types of reflux involving superficial, deep and perforator veins. Its development is linked to a cutaneous microangiopathy, the central element of which is a decreased capillary density. Venous symptoms are quite widespread and women are more concerned than men; they are also of a multifactorial origin, varicose veins being only one of the causative factors. Their pathogenesis remains unclear, involving venous stasis and probably a functional insufficiency of the lymphatic system.

[Comparison of the effectiveness and cost of treatment with humid environment as compared to traditional cure. Clinical trial on primary care patients with venous leg ulcers and pressure ulcers]. / Comparación de la efectividad y coste de la cura en ambiente húmedo frente a la cura tradicional. Ensayo clinico en pacientes de atención primaria con úlceras vasculares y por presión.

INTRODUCTION: The discovery of moist environment dressings as alternatives to the traditional treatments based on exposing wounds to air, opened new expectations for the care and treatment of chronic wounds. Over the years, these expectations have led to the availability of new moist environment dressings which have made it possible to improve the care provided to patients suffering this kind of wounds, as well as providing important reasons to weigh in terms of cost-benefit-effectiveness at the time of selecting which type of treatment should be employed. The lack of comparative analysis among traditional treatments and moist environment treatments for chronic wounds among patients receiving primary health care led the authors to perform an analysis comparing these aforementioned options of treatment on patients suffering venous leg ulcers or pressure ulcers. PATIENTS, MATERIALS AND METHODS: The authors designed a Randomized Clinical Trial involving patients receiving ambulatory care in order to compare the effectiveness and cost-benefit of traditional versus moist environment dressing during the treatment of patients suffering stage II or III pressure ulcers or venous leg ulcers. In this trial, variables related to effectiveness of both treatments, as well as their costs were analyzed. MAIN RESULTS: 70 wounds were included in this Randomized Clinical Trial, 41 were venous leg ulcers of which 21 received a moist environment treatment while 20 received traditional cure, the other 29 wounds were pressure ulcers of which 15 received moist environment dressings treatment and 14 received traditional dressings. No statistically significant differences were found among the defining variables for these lesions in either group under treatment. In the venous leg ulcer study group, the authors conclusions were an average of 18.13 days, 16.33 treatment sessions and a cost of 10,616 pesetas to heal one square centimeter of the initial surface area of a wound on patients treated with traditional treatment compared to an average of 18.22 days, 4.54 treatment sessions and a cost of 2409 pesetas to heal one square centimeter of the initial surface area of a wound on patients treated with moist environment dressings. In the pressure ulcers study group, the authors conclusions were an average of 12.18 days, 12.1 treatment sessions and a cost of 15,490 pesetas to heal one square centimeter of the initial surface area of a wound on patients treated with traditional treatment compared to an average of 7.12 days, 1.86 treatment sessions and a cost of 2610 pesetas to heal one square centimeter of the initial surface area of a wound on patients treated with moist environment dressings. COMMENTS: The results of this randomized clinical trial demosntrated that the moist environment treatment group was more effective and had a better cost-benefit ratio than the traditional treatment group in the treatment of pressure ulcers and venous leg ulcers on patients cared for by nursing personnel in primary health care centers all of which agrees with publications consulted by authors.

Leg ulceration in the sickle cell patient.

BACKGROUND: The purpose of this study was to determine cost of care for leg ulcers in sickle cell patients and suggest an improved modality in ulcer care. STUDY DESIGN: We performed a retrospective study of a group of sickle cell disease patients with leg ulcers. RESULTS: Eighteen patients with a leg ulcer (duration: mean, 53.7 months), sickle cell disease, and a mean of 20.7 years of age had various modalities of treatment with the only consistency in healing being a commercial moist-wound dressing. CONCLUSIONS: There is no consistency in the treatment of the sickle cell patient with a leg ulcer. Treatment with a moist dressing had the best results.

[Drug clinics. How I treat a cutaneous ulcer in outpatients]. / Pharma-clinics. Comment je traite.... Un ulcère cutané en ambulatoire.

Leg ulcers are the source of high social and economical costs in the domain of geriatric dermatology. The present review summarizes the indications of antiseptics and of sophisticated wound dressings including hydrogels, hydrocolloids, alginates, polyurethane foams and films, as well as formulations combatting the smelly aspects of ulcers.