Status:
TERMINATED
Decellularised Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
University of Edinburgh
Universidad de Granada
Conditions:
Venous Ulcer
Allograft
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- ≥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
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2023
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04021316
Start Date
October 1 2019
End Date
April 10 2023
Last Update
September 28 2023
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
North Bristol NHS Trust
Bristol, United Kingdom
2
Cardiff and Vale University Health Board
Cardiff, United Kingdom
3
North Cumbria University Hospitals NHS Trust
Carlisle, United Kingdom
4
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, United Kingdom