Abstract
Objective:
Hard-to-heal (chronic) venous leg ulcers (VLUs) are challenging to heal with standard of care (SoC) alone. This study evaluated whether adding a thigh-administered intermittent pneumatic compression (IPC) device (WoundExpress, Huntleigh Healthcare Ltd., UK) to SoC improved outcomes in patients with hard-to-heal venous or mixed leg ulcers (venous and arterial), was suitable for home use and was safe.
Method:
A multicentre, pragmatic, open-label, randomised controlled trial (RCT) was conducted across the UK, US, Germany and France. Adults with hard-to-heal lower limb VLUs and mixed ulcers already receiving compression were randomised 1:1 to adjunctive IPC (two hours/day; intervention) plus SoC, or SoC alone (control), for 16 weeks. The primary outcome was percentage change in wound area. Secondary outcomes included: complete healing; wound pain; quality of life (QoL); acceptability; usage; and safety.
Results:
A total of 136 patients were randomised (n=65 IPC; n=71 control); 116 patients completed the study. Median wound area reduction at 16 weeks was similar: (intervention: 64.0% versus control: 67.7%; p=0.35). Complete healing occurred in 16.9% (IPC) and 18.3% (control) patients (p=0.80). Pain scores and QoL improved modestly in both groups, with no between-group differences. The IPC device was well tolerated: 64% of patients rated it ‘very good’ or ‘excellent’. Mean use was ~2.0 hours/day, as reported in patient diaries. Adverse events were primarily mild and comparable (54% IPC; 59% control); only one mild event was device-related.
Conclusion:
In this RCT, thigh-administered IPC did not improve healing beyond SoC in this patient population, although it was safe, well-tolerated, and feasible for home use.