Decellularised Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration

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

Conditions

• Venous Ulcer
• Allograft

Interventions

OTHER

dCELL® Human Dermis (decellularised dermal skin allograft - DCD)

DCD is produced from split thickness skin grafts (which comprise the epidermis and upper part of the dermis), and is retrieved from deceased tissue donors. All epidermal and cellular components from the dermis are removed in a patented sequential decellularisation process. As a decellularised graft, dCELL® Human Dermis fully integrates into the wound bed after application, replacing lost dermal tissue. It provides a scaffold into which the recipient's cells can grow, becoming vascularised and supporting the generation of a new epidermis, ultimately regenerating into normal skin.

OTHER

Compression bandaging therapy

Compression therapy will be according to local practice and may include multilayer elastic compression bandaging or stockings delivering 20 to 40mm/Hg pressure.

Sponsors & Collaborators

• University of Edinburgh

  collaborator OTHER

• Universidad de Granada

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• Gloucestershire Hospitals NHS Foundation Trust

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• University of Birmingham

  collaborator OTHER

• NHS Blood and Transplant

  collaborator OTHER_GOV

• Imperial College London

  lead OTHER

Principal Investigators

• Alun H Davies · Imperial College London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-01

Primary Completion

2023-04-10

Completion

2023-04-10

Countries

• United Kingdom

Study Locations