Patient-centered Outcomes for Individuals with a Venous Leg Ulcer: A Scoping Review

GENERAL PURPOSE To summarize randomized clinical trials addressing patient-centered outcomes of individuals with a venous leg ulcer. TARGET AUDIENCE This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. LEARNING OBJECTIVES/OUTCOMES After participating in this educational activity, the participant will: 1. Summarize the results of the review of randomized controlled trials addressing patient-centered outcomes of individuals with a venous leg ulcer. 2. Identify the limitations of the research analyzed for the review. ABSTRACT OBJECTIVE To summarize randomized clinical trials addressing patient-centered outcomes of individuals with a venous leg ulcer with a scoping review. DATA SOURCES Authors searched PubMed using MESH terms for “venous ulcer” AND “randomized” for randomized clinical trials published from January 2002 to October 2021 that explored content-validated patient-centered outcomes for individuals with a clinically diagnosed venous leg ulcer. Authors also searched Cochrane Reviews from inception to April 15, 2022 for additional references using the same MESH terms. STUDY SELECTION Studies in any setting were included if primary or secondary outcomes were venous ulcer-related mobility, pain or analgesic use, healing, infection, quality of life (including odor, social isolation, depression), amputation, or patient-level costs of treatment. Preclinical or nonrandomized clinical studies or those without venous leg ulcers were excluded. DATA EXTRACTION Authors tabulated interventions studied, numbers of patients treated per group, risk of delayed ulcer healing, and statistical significance of comparisons of 485 qualifying articles in Google Sheets. DATA SYNTHESIS Authors graphically represented and tabulated frequencies of studies addressing patient-centered outcomes of individuals with venous ulcers. Studies mainly reported effects of compression, dressings, topical antimicrobials, or systemic therapy on patient healing or pain outcomes. Related ischemia, ultrasonography, or risk factors for delayed healing were not consistently reported, inflating variability of outcomes and decreasing consistency of differences reported. CONCLUSIONS Research is needed on the mobility, amputation risk, infection risk, quality of life, and healthcare costs of patients with venous ulcers. Promising interventions include grafts, exercise, analgesics, electrical modalities, negative pressure, or vascular interventions. Consistently reporting each patient’s baseline ischemia and vascular condition would improve relevance.