AB072. SOH25_AB_163. A systematic review and in-depth analysis of outcome reporting in early phase studies of novel interventions for diabetic foot ulcer

Background: Diabetic foot ulceration (DFU) is a leading cause of morbidity, with acute hospital admissions occurring at a rate of 16 per 1,000 person-years among diabetics. Strategies to prevent complications include patient education, pressure relief, monitoring foot temperature, biomechanical surgery, and topical agents. However, inconsistent measurement and reporting of outcomes hinder evaluation, presenting risks to patients and delaying evidence synthesis. The COHESIVE core outcome set addresses these challenges by standardizing outcome measurement and reporting in studies of innovative interventions. To date, patterns of outcome reporting have been evaluated only in colorectal cancer surgery. This project evaluates outcome reporting in early-phase studies of novel DFU interventions.

Methods: Systematic searches identified studies of topical or invasive procedures for DFU treatment. A random sample of studies self-reporting treatments as new or modified was included. Outcomes were extracted and categorized using the COHESIVE framework’s eight domains. Reporting patterns were analyzed.

Results: Of 442 records, 301 were potentially eligible. Full-text review of 50 random studies identified 38 for inclusion: 16 (42%) were ‘new’, and 22 (58%) were ‘not explicitly reported’. A total of 127 outcomes were identified, with all mapped to domains. ‘Procedure completion success’ was most frequently reported (100%), while ‘Surgeons’ psychological or physical experience’ was never reported.

Conclusions: Despite the COHESIVE framework, outcome reporting remains highly variable. Future early-phase evaluations should adopt this framework to improve consistency and facilitate evidence synthesis for novel DFU treatments.

Keywords: Clinical trial; diabetic foot ulcers; early phase; novel therapies; outcome reporting