Multicentric, randomized, open-label, three-arm postmarketing clinical study of VELVERT with single- and four-layer...

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.

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

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 end points included complete wound closure, percentage wound size reduction, and microbiological assessment. Secondary end points were pain intensity, safety, and the number of dressings required for healing.

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, whereas 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.

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.