Venous Ulcer Clinical Trial
— DAVEOfficial title:
Decellularised Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration
Verified date | September 2023 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Does the use of decellularised dermis allograft in addition to compression therapy promote healing in chronic venous leg ulceration compared to compression therapy alone
Status | Terminated |
Enrollment | 71 |
Est. completion date | April 10, 2023 |
Est. primary completion date | April 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | 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 |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | Cambridge University Hospitals NHS Foundation Trust, Gloucestershire Hospitals NHS Foundation Trust, NHS Blood and Transplant, Universidad de Granada, University of Birmingham, University of Edinburgh, University of Manchester |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion with a healed index ulcer at 12 weeks after randomisation. | 12 weeks | ||
Secondary | Time to index ulcer healing from randomisation | 12 months | ||
Secondary | The percentage change in index ulcer area in cm2 at 12 weeks from randomisation | 12 weeks | ||
Secondary | The proportion of participants with a healed index ulcer at 12 months from randomisation | 12 months | ||
Secondary | The proportion of participants whose index ulcer healed for whom an ulcer recurred at the index site within 12 months from randomisation | 12 months | ||
Secondary | Generic quality of life using the EuroQol-5D (EQ-5D) questionnaire | 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 | 12 weeks, 6 months and 12 months from randomisation | |
Secondary | Disease specific quality of life using the Charing Cross Venous Ulcer Questionnaire (CCVUQ) | Scale 0 to 100, with lower scores indicating better quality of life | 12 weeks, 6 months and 12 months from randomisation | |
Secondary | The cost for each patient, calculated from the healthcare resources used | 12 months | ||
Secondary | Incremental cost-effectiveness ratio (ICER) from the EQ-5D questionnaire, with appropriate sensitivity analysis | 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 | 12 months |
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