The measurement and reporting of healing-related outcomes in randomised controlled trials of compression for venous leg ulcers: a systematic review

AIM: Venous leg ulcers (VLUs) are the most prevalent type of leg ulcer and can be slow to heal. Compression therapy is a widespread, evidence-based treatment for people with VLUs, with many associated randomised controlled trials (RCTs). Healing-related outcomes are important in the field but there is currently limited insight on how these outcomes are captured and reported in RCTs. This review analyses the measurement and reporting of healing-related outcomes in RCTs of compression therapy in people with VLUs. METHODS: This systematic review followed the Cochrane guidelines and is reported in line with the PRISMA statement. RCTs of compression for people with VLUs were included. Five medical literature databases were searched (September 2024), and data were extracted on the type of healing outcomes assessed, the follow-up time, the used definitions of healing-related outcomes, the wound measurement techniques, and the use and techniques of assessor masking. RESULTS: This review included 68 RCTs, reporting 158 healing-related outcomes. These outcomes commonly evaluated change in wound size (34%) or complete wound closure (59%). Only 44% of complete wound closure outcomes were accompanied by a clear definition, and those definitions varied. Change in wound size was measured by four techniques, with planimetry used most often (51%). Notably, 56% of healing-related outcomes were evaluated by healthcare professionals and none by patients. The use of assessor masking was limited: in 38% of cases outcomes were judged by unmasked assessors, and in 42% the masking status was unclear. Follow-up duration was most commonly between 90 days and 6 months. CONCLUSION: This is the first systematic review to investigate the measurement and reporting of healing-related outcomes in RCTs of compression therapy for people with VLUs. Although healing-related outcomes including complete wound closure were frequently used in the included RCTs, limitations in measuring and reporting were identified. These limitations included frequent collection of surrogate outcomes, limited follow-up periods, inconsistent use of outcome definitions, variation in wound measurement techniques, and lack of assessor masking. Development of a set of guidelines on the measurement and reporting of healing-related outcomes could help to address these limitations. REGISTRATION: The protocol for this systematic review has been registered on the Open Science Framework platform and can be viewed HERE.