Safety and performance of a new non-adhesive foam dressing for the treatment of diabetic foot ulcers.

OBJECTIVE

This study aimed to document the safety and performance of a new non-adhesive foam dressing (Biatain Non-adhesive Dressing, Coloplast A/S) in the treatment of established foot ulcers in patients with diabetes.

METHOD: This was an open non-comparative prospective study. Participants had an ankle brachial pressure index score of over 0.4 (neuro-ischaemic) and an ulcer bigger than 1 cm2 and less than 8 cm2 in any direction. The treatment period was six weeks.

RESULTS

Thirty-five out of 37 patients completed the study. The mean wound area reduced from 5.4 cm2 to 2.5 cm2. Relative wound area reduced from 100% at baseline to 40% at week 6. 'Wearing comfort' improved throughout the study (p = 0.039). Maceration remained stable or improved. None of the four reported adverse events were device related.

CONCLUSION

This study demonstrates that treatment of diabetic foot ulcers with Biatain Non-adhesive Dressing results in considerable wound area reduction and prevents any deterioration in maceration. The dressing is safe and effective in the management of these ulcers.