Decellularised Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration

NCT04021316 | Terminated DMC

• 1 other identifier: 19CX5371
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 17

Brief 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

Keywords

Compression therapy; Ulcer

Outcome Measures

Primary Outcomes (1)

• Proportion with a healed index ulcer at 12 weeks after randomisation.

  12 weeks

Secondary Outcomes (8)

• Time to index ulcer healing from randomisation

  12 months

• The percentage change in index ulcer area in cm2 at 12 weeks from randomisation

  12 weeks

• The proportion of participants with a healed index ulcer at 12 months from randomisation

  12 months

• The proportion of participants whose index ulcer healed for whom an ulcer recurred at the index site within 12 months from randomisation

  12 months

• Generic quality of life using the EuroQol-5D (EQ-5D) questionnaire

  12 weeks, 6 months and 12 months from randomisation

Study Arms (2)

Standard care arm

ACTIVE COMPARATOR

Compression bandaging therapy as per standard care

Other: Compression bandaging therapy

DCD Arm

EXPERIMENTAL

DCD graft plus compression bandaging therapy as per standard care

Other: dCELL® Human Dermis (decellularised dermal skin allograft - DCD); Other: Compression bandaging therapy

Interventions

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

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.

DCD Arm

Compression bandaging therapy OTHER

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

DCD Arm; Standard care arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years or older (no upper age limit)
• The ability to consent to participation
• A diagnosis of venous leg ulceration\* (defined as 'colour duplex confirmation of superficial and or deep venous reflux with any break in the skin that has either: a) been present for more than 2 weeks, or b) occurred in a person with a history of venous leg ulceration)
• Documented venous incompetence on duplex ultrasound
• Index ulcer wound duration of greater than 3 months
• Index ulcer wound size ≥ 2 cm2.
• ABPI ≥ 0.8
• in light of the Covd-19 pandemic, the use of handheld continuous wave Dopplers will be allowed to diagnose venous disease to allow participants to be recruited from clinic without the need for an imaging appointment

You may not qualify if:

• A diagnosis of sickle cell
• Unable to receive one or more of the randomised treatment strategies for any reason at the discretion of the attending clinical team (e.g. known allergies to dCELL dermis preparation components)
• A clinically infected ulcer defined as evidence of erythema, cellulitis or systemically unwell
• Treatment with biomedical/topical growth factors within previous 30 days
• Previous history of an inability to tolerate compression therapy
• Foot ulcer (i.e. below the ankle)

Sponsors & Collaborators

• Imperial College London: lead
• University of Edinburgh: collaborator
• Universidad de Granada: collaborator
• University of Manchester: collaborator
• Gloucestershire Hospitals NHS Foundation Trust: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• University of Birmingham: collaborator
• NHS Blood and Transplant: collaborator

Study Sites (17)

North Bristol NHS Trust

Bristol, United Kingdom

Location

Cardiff and Vale University Health Board

Cardiff, United Kingdom

Location

North Cumbria University Hospitals NHS Trust

Carlisle, United Kingdom

Location

Gloucestershire Hospitals NHS Foundation Trust

Gloucester, United Kingdom

Location

AT Medics

London, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

London North West University Healthcare

London, United Kingdom

Location

St Charles Centre for Health and Welbeing, Central London Community Healthcare NHS Trust

London, United Kingdom

Location

Aneurin Bevan University Health Board

Newport, United Kingdom

Location

Northampton General Hospital NHS Trust

Northampton, United Kingdom

Location

Livewell

Plymouth, United Kingdom

Location

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Location

Swansea Bay University Health Board

Swansea, United Kingdom

Location

Taunton and Somerset NHS Foundation Trust

Taunton, United Kingdom

Location

Mid Yorkshire Hospitals NHS Trust

Wakefield, United Kingdom

Location

Worcestershire Acute Hospitals NHS Trust

Worcester, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alun H Davies

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to mask participants or the research/clinical teams to the treatment strategy as the DCD graft is visible after application for a period of time. However the primary outcome assessments (verification of index ulcer healing visits) will be completed by an independent clinical assessor trained in the assessment of wound healing, who will have no previous involvement with, or knowledge of, the participant's index ulcer treatment and as such will be blind to the randomised treatment strategy (as the DCD is not expected to be visible after 4 weeks).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will undergo 1:1 web based randomisation to either standard care or the intervention via an automated system. A minimization algorithm using centre, index ulcer size and duration will be used, including a random component to lessen predictability. A separate Randomisation System Description document will contain full details of the cut-offs for index ulcer size and duration, and the probability that the allocation will be switched.

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 16, 2019
• Study Start: October 1, 2019
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (17)