Decellularised Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration

Not Applicable

Terminated

• Conditions: Allograft; Venous Ulcer
• Interventions: Other: dCELL® Human Dermis (decellularised dermal skin allograft - DCD); Other: Compression bandaging therapy

• Registration Number: NCT04021316
• Lead Sponsor: Imperial College London

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-16
• Study Start: 2019-10-01
• Primary Completion: 2023-04-10
• Study Completion: 2023-04-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• ≥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

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Exclusion Criteria

• 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DCD Arm	dCELL® Human Dermis (decellularised dermal skin allograft - DCD)	DCD graft plus compression bandaging therapy as per standard care
Standard care arm	Compression bandaging therapy	Compression bandaging therapy as per standard care
DCD Arm	Compression bandaging therapy	DCD graft plus compression bandaging therapy as per standard care

Primary Outcome Measures

Name	Time	Method
Proportion with a healed index ulcer at 12 weeks after randomisation.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Disease specific quality of life using the Charing Cross Venous Ulcer Questionnaire (CCVUQ)	12 weeks, 6 months and 12 months from randomisation	Scale 0 to 100, with lower scores indicating better quality of life
Time to index ulcer healing from randomisation	12 months
The proportion of participants with a healed index ulcer at 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	A health index on a score of 0 to 1 and the participants' self-rated health on a vertical score of zero to 100. Higher scores indicate better quality of life
The cost for each patient, calculated from the healthcare resources used	12 months
Incremental cost-effectiveness ratio (ICER) from the EQ-5D questionnaire, with appropriate sensitivity analysis	12 months	An intervention may be considered cost-effective when its ICER is less than the threshold set by health policy decision-makers. In the UK, the cost-effectiveness threshold is currently in the range £20 000-30 000 per QALY
The percentage change in index ulcer area in cm2 at 12 weeks from randomisation	12 weeks
The proportion of participants whose index ulcer healed for whom an ulcer recurred at the index site within 12 months from randomisation	12 months

Trial Locations

Locations (17)

North Bristol NHS Trust; 🇬🇧 Bristol, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom

Aneurin Bevan University Health Board; 🇬🇧 Newport, United Kingdom

Livewell; 🇬🇧 Plymouth, United Kingdom

Gloucestershire Hospitals NHS Foundation Trust; 🇬🇧 Gloucester, United Kingdom

North Cumbria University Hospitals NHS Trust; 🇬🇧 Carlisle, United Kingdom

AT Medics; 🇬🇧 London, United Kingdom

Cardiff and Vale University Health Board; 🇬🇧 Cardiff, United Kingdom

St Charles Centre for Health and Welbeing, Central London Community Healthcare NHS Trust; 🇬🇧 London, United Kingdom

Swansea Bay University Health Board; 🇬🇧 Swansea, United Kingdom

London North West University Healthcare; 🇬🇧 London, United Kingdom

Northampton General Hospital NHS Trust; 🇬🇧 Northampton, United Kingdom

University Hospitals Plymouth NHS Trust; 🇬🇧 Plymouth, United Kingdom

Mid Yorkshire Hospitals NHS Trust; 🇬🇧 Wakefield, United Kingdom

Worcestershire Acute Hospitals NHS Trust; 🇬🇧 Worcester, United Kingdom

Taunton and Somerset NHS Foundation Trust; 🇬🇧 Taunton, United Kingdom

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom