Work

Feasibility of a prospective cohort study to support future investigation of prognostic factors for venous leg ulcer healing

Year: 2026

Type: article

Abstract: a:2:{s:4:"lang";s:2:"en";s:7:"content";s:2570:" Objectives To evaluate the feasibility of recruitment, longitudinal clinical data collection and repeated dressing-sample collection within routine NHS community venous leg ulcer centres, to inform a future larger prospective cohort study evaluating prognostic factors for venous leg ulcer healing. Design Prospective, longitudinal feasibility cohort study with repeated measures. Setting Three community leg ulcer clinics in Greater Manchester, UK. Participants 100 adults with venous leg ulcers. Interventions Recruitment commenced from 1 August 2023 to 29 July 2024 with follow-up data collection continuing until 2 October 2024 (62 weeks in total). The study integrated two key components: use of the ComplexWounds{at}Manchester Biobank as a supporting research infrastructure, and implementation of a novel biomarker methodology involving wound fluid collection from patient dressings. Outcome measures were monitored until the venous leg ulcer healed or until the end of the study. Outcome measures Participant recruitment, participation, feasibility of collecting baseline and follow-up clinical data, healing outcomes, biological sampling and participant retention. Results Of 101 eligible patients, 99% consented, 100 participants were recruited over a period of 53 weeks. With the exception of body mass index data (missing for 11 participants), there were minimal missing baseline data. During the study, 74 participants achieved complete healing, with 10 participants remaining unhealed at study end, 4 lost to follow-up, 9 withdrawn from clinic and 3 withdrawn from the study. Biological sampling was feasible with a mean of five samples collected per participant. Dressing practices were heterogeneous, with 45 dressing types used in total. The median time taken from the Biobank’s collection of the last dressing sample of the day, transport and processing before storage in the laboratory for all clinic sessions was 85 min. Conclusions Biobank-supported recruitment, longitudinal clinical data collection and repeated dressing-sample collection were integrated into routine community venous leg ulcer clinics with no observed impact on usual standard of care. These findings support the feasibility of larger-scale prospective cohort studies evaluating prognostic factors for venous leg ulcer healing, although future studies should include longer follow-up, recruitment closer to ulcer onset and prespecified progression criteria. ";}

Source: BMJ Open

DOI: 10.1136/bmjopen-2026-122867