Multicentric, Randomized, Open-Label, Three-Arm Post Marketing Clinical Study of VELVERT® with Single- and Four-Layer Compression, for Venous Leg Ulcer.

BACKGROUND

Venous leg ulcers (VLUs) are chronic, slow-healing wounds related to chronic venous insufficiency, and they represent a significant clinical and economic burden. Despite compression therapy being the standard of care, healing remains suboptimal in many patients, necessitating improved wound care strategies.

OBJECTIVE

To evaluate the comparative efficacy, safety, and clinical performance of VELVERT® advanced wound care dressing alone, VELVERT® combined with VELSOFT® compression bandage, and the VELFOUR® four-layer compression system in the management of VLUs.

METHODS

This randomized, interventional, open-label, multicentric clinical study was conducted at MLB Medical College, Jhansi, and Nizam Institute of Medical Sciences, Hyderabad. Sixty-six subjects were enrolled, of whom 61 completed treatments through Day 60 or until complete wound healing. Primary endpoints included complete wound closure, percentage wound size reduction, and microbiological assessment. Secondary endpoints were pain intensity, safety, and the number of dressings required for healing.

RESULTS

At Day 60, mean wound size reduction was 57.72% in the VELVERT® group (n=22), 67.03% in the VELVERT® + VELSOFT® group (n=20), and 65.79% in the VELFOUR® group (n=19). Overall, 42.6% of participants achieved complete wound closure, with the highest rate in the VELVERT® + VELSOFT® group (50.0%), followed by the VELFOUR® (42.1%) and VELVERT® (36.4%) groups. Complete microbial clearance occurred in the VELVERT® and VELVERT® + VELSOFT® groups, while minimal residual microbial growth was observed in the VELFOUR® group. Pain scores improved significantly across all groups. Adverse events were infrequent, mild to moderate, and unrelated to the study devices.

CONCLUSION

All three treatment strategies improved wound healing, pain, and infection control. VELVERT® combined with VELSOFT® demonstrated the most consistent clinical benefits, including greater wound size reduction, the highest wound closure rate, complete microbial clearance, and an excellent safety profile. These findings support VELVERT® with VELSOFT®, and VELVERT® alone, as effective and well-tolerated compression-based wound care options for VLUs.