Decellularised Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration
NCT ID: NCT04021316
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
71 participants
INTERVENTIONAL
2019-10-01
2023-04-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard care arm
Compression bandaging therapy as per standard care
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.
DCD Arm
DCD graft plus compression bandaging therapy as per standard care
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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University of Edinburgh
OTHER
Universidad de Granada
OTHER
University of Manchester
OTHER
Gloucestershire Hospitals NHS Foundation Trust
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
University of Birmingham
OTHER
NHS Blood and Transplant
OTHER_GOV
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Alun H Davies
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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North Bristol NHS Trust
Bristol, , United Kingdom
Cardiff and Vale University Health Board
Cardiff, , United Kingdom
North Cumbria University Hospitals NHS Trust
Carlisle, , United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, , United Kingdom
AT Medics
London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
London North West University Healthcare
London, , United Kingdom
St Charles Centre for Health and Welbeing, Central London Community Healthcare NHS Trust
London, , United Kingdom
Aneurin Bevan University Health Board
Newport, , United Kingdom
Northampton General Hospital NHS Trust
Northampton, , United Kingdom
Livewell
Plymouth, , United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, , United Kingdom
Swansea Bay University Health Board
Swansea, , United Kingdom
Taunton and Somerset NHS Foundation Trust
Taunton, , United Kingdom
Mid Yorkshire Hospitals NHS Trust
Wakefield, , United Kingdom
Worcestershire Acute Hospitals NHS Trust
Worcester, , United Kingdom
Countries
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Other Identifiers
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19CX5371
Identifier Type: -
Identifier Source: org_study_id
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