Impact on healing of double-layered compression stocking in the treatment of severe venous leg ulcers: A prospective, multicenter, controlled trial.

Venous leg ulcer refers to chronic wounds, generally difficult to heal and often prone to recurrence. The objective of this research was to assess a double layered compression stocking VenoTrain® ulcertec on a population with mostly severe pathologies. This prospective, multicenter, interventional type II study was conducted between September 2018 and January 2022. Out of 124 patients enrolled, 97.6% had a history of previous leg ulceration, 72.6% were already being followed for leg ulcerations, 30.9% were severely overweight and 24.2% diabetic. Overall, a majority of target ulcers were present for 6months or more, and the ulcer surface area was larger than 8cm2 in nearly one in every five cases. The primary endpoint was the rate of closed ulcer after a maximum follow-up of 20weeks. While most of the treated venous leg ulcerations may be regarded as hard-to-heal wounds, closure rate at 20weeks ranged between 50.0% (two severity criteria) and 69.0% (no severity criteria) according to baseline wound severity criteria. Besides, VenoTrain® ulcertec device was particularly well accepted and tolerated by patients. In 93.2% of visits, patients stated using it every day. When managing venous ulcerations not requiring strongly thick absorbent dressings, VenoTrain® ulcertec device represents an efficient and more suitable alternative to venous compression bandaging.