Endovenous Ablation of Superficial Venous Reflux Combined With Fat Grafting Vs Endovenous Ablation Alone for the Treatment of Patients With Venous Ulcers: A Prospective Randomised Clinical Pilot Study

Study design:

This is a randomised, prospective, active-control pilot study to compare the effectiveness of fat grafting combined with endovenous ablation to endovenous ablation alone on wound healing in patients with venous ulcers in a tertiary vascular care centre. This study will randomise 20 patients with venous ulcers in an equal ratio to one of two treatment arms. The intervention arm will be randomised to undergo endovenous ablation of superficial venous reflux combined with fat grafting at the same setting. The control arm will be offered endovenous ablation only. All patients in both arms will receive compression therapy until full ulcer healing. They will then be followed up in the outpatient clinic every 4 weeks to record wound size and to monitor any adverse events.

Study setting:

Potential participants will be identified, screened and randomised at the vascular outpatient clinics within the Saolta group university hospitals, Ireland. Patients in both arms will receive the intervention in operating theatre in Roscommon University Hospital (RUH). Fat grafting will be performed under the supervision of a plastic surgeon. The coordinating centre will be the Department of Vascular and Endovascular Surgery, University College Hospital Galway (UCHG), and the School of Medicine at the National University of Ireland Galway (NUI Galway).

Study screening: