Quality of life in venous ulceration: A randomized trial of two bandage systems

Objective: To evaluate health-related quality of life (HRQoL) in a prospective randomised trial of patients suffering from venous ulceration, comparing the original four-layer bandage system with a new four-layer system (Profore). Design: Randomised prospective parallel groups trial. Setting: Community leg ulcer clinics within two trusts in England. Participants: Patients newly presenting for treatment suffering from chronic leg ulceration, with ankle-brachial pressure index (ABPI) > 0.8. Methods: Patients entering the trial were asked to complete the Nottingham Health Profile (NHP) at entry and after 12 and 24 weeks of treatment. Principal analysis was the comparison of final NHP scores analysed by ANOVA with baseline scores entered as a covariate. Results: In all, 231 of 232 patients who entered the trial completed the initial questionnaire, with 208 patients completing at least one follow-up questionnaire. Improvements were noted for all scores after 24 weeks, which were significantly greater in the 167 patients whose ulcers had healed compared with the 41 whose ulcers remained unhealed for the domains of Sleep (mean difference [d] = 10.5, 95% CI 2.9 to 18.1, p = 0.007) and Bodily Pain (d = 8.9, 95% CI 1.3 to 16.5, p = 0.023), with a large difference for Physical Mobility (d = 5.0) which failed to achieve statistical significance (95% CI - 0.5 to 10.6, p = 0.07) following adjustment for the baseline scores. There were similar mean scores between the 99 patients treated with the original bandage system and 109 treated with Profore for all domains of the NHP, the largest adjusted difference favouring Profore for Energy (d = 3.7, 95% CI -3.8 to 11.2, p=0.34). Conclusions: Patients suffering from leg ulceration show improvements in perceived health following effective ulcer management. The two bandage systems achieved similar improvements in perceived health over 24 weeks.