Heel-Free Compression Bandaging for Venous Leg Ulcers: A Non-Inferiority Trial of Interface Pressure.

To determine whether heel-free compression bandaging is non-inferior to heel-wrapped bandaging for maintaining interface pressure in adults with venous leg ulcers. Randomised, controlled, parallel-group, non-inferiority trial. Adults with open venous leg ulcers (CEAP C6) treated at a French university hospital were randomised to heel-free or heel-wrapped (control) bandaging for 4-6 weeks. The primary outcome was interface pressure 48 h after the final bandage application, analysed in the per-protocol population. Secondary outcomes were ankle oedema, change in interface pressure and patient preference. Of 102 randomised patients, 85 were included in the per-protocol analysis. At V3, mean interface pressure was 30.1 mmHg in the heel-free group and 28.4 mmHg in the control group (difference, 1.7 mmHg; 95% CI, -1.3 to 4.6), meeting the non-inferiority criterion. After adjustment for baseline circumference and sex, ankle circumference was 1.7 cm lower in the heel-free group (95% CI, -3.35 to 0.04). Among 48 patients who had experienced both techniques, 23 (47.9%) preferred heel-free bandaging. Heel-free bandaging was non-inferior to heel-wrapped bandaging for interface pressure at 48 h. The technique may be considered when compatible with ulcer location and patient preference; effects on healing and adherence require further study. Trial Registration: NCT04046120.