Decellularised Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration — DAVE  

Venous Ulcer Clinical Trial

Official title: Decellularised Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration

Status Terminated

Clinical Trial Summary

Does the use of decellularised dermis allograft in addition to compression therapy promote healing in chronic venous leg ulceration compared to compression therapy alone

Clinical Trial Description

Chronic venous ulceration are open wounds on the lower limbs which have been present for at least three months and are caused by a poorly functioning venous system. The affect about 1% of the general population and about 4% of those over 65. The wounds cause pain, reduced movement, and can smell - greatly affecting the quality of life of leg ulcer patients. The standard care for these patients is compression bandaging, which requires changing several times a week by community or district nurses; this drives the high cost of leg ulcer care, which can amount to £2.5 billion per annum.

Skin grafting can be used alongside compression bandaging and can help the ulcers heal faster than compression alone. Grafts can be taken from the patient's own skin, from a donor or from tissue engineered skin. An autograft (using own skin) can cause scarring and the need for a formal surgical procedure in theatre so are not suitable for all ulcer patients. Allografts (donor skin) and xenografts (animal skin) have been used successfully, but present similar drawbacks to autografts, plus the potential for the body to reject the graft and disease transmission. Tissue engineered skin has several advantages as it has been processed to remove the cells, and therefore is won't be rejected via the immune response. Human decellularised dermis (DCD) is generated from donated skin from deceased people and processed to remove the cells. It can be glued or sewn onto the skin under local anesthetic, in an out patient setting. DCD has mainly been studied in patients with diabetic foot ulceration and has shown improved healing rates and quality of life.

This study will investigate the use of DCD in addition to compression therapy versus compression therapy alone in patients with chronic venous leg ulceration. ;

Related Conditions & MeSH terms

• Allograft
• Varicose Ulcer
• Venous Ulcer

• NCT number: NCT04021316
• Study type: Interventional
• Source: Imperial College London
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2019
• Completion date: April 10, 2023