Decellularised Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    196
  • sponsor
    Imperial College London
Updated on 16 August 2021
reflux
duplex ultrasound
compression therapy

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

Description

Chronic venous ulceration are open wounds on the lower limbs which have been present for at least six 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.

Details
Condition Varicose Ulcer, Varices, Venous stasis, Leg Ulcer, Allogeneic transplantation, Venous Leg Ulcers, Varicose Veins, transplantation, allogeneic, venous ulcers, venous ulcer
Treatment dCELL® Human Dermis (decellularised dermal skin allograft - DCD), Compression bandaging therapy
Clinical Study IdentifierNCT04021316
SponsorImperial College London
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 6 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

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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