Can the use of decellularised dermis allograft (DCD) help improve ulcer healing in patients with chronic venous leg ulceration?
- Conditions
- Chronic venous leg ulcerationCirculatory System
- Registration Number
- ISRCTN21541209
- Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33811051/ (added 06/04/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 71
Current inclusion criteria as of 16/04/2020:
1. > = 18 years or older (no upper age limit)
2. The ability to consent to participation
3. 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)
4. A wound duration of at least 6 months
5. Documented venous incompetence on duplex ultrasound
6. Ulcer wound size > 2 cm2.
7. ABPI > = 0.8, or if the ABPI is incompressible, other forms of clinical assessment must exclude peripheral arterial disease (peripheral pulse examination, toe pressure, duplex ultrasound, clinical judgment)
*if more than one ulcer is present, the largest ulcer will be chosen as the reference ulcer for the purposes of the trial
Previous inclusion criteria:
1. > = 18 years or older (no upper age limit)
2. The ability to consent to participation
3. 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)
4. A wound duration of 6 to 24 months inclusive
5. Documented venous incompetence on duplex ultrasound
6. Ulcer wound size > 2 cm2.
7. ABPI > = 0.8, or if the ABPI is incompressible, other forms of clinical assessment must exclude peripheral arterial disease (peripheral pulse examination, toe pressure, duplex ultrasound, clinical judgment)
*if more than one ulcer is present, the largest ulcer will be chosen as the reference ulcer for the purposes of the trial
Current exclusion criteria as of 16/04/2020:
1. A diagnosis of sickle cell
2. 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)
3. A clinically infected ulcer defined as evidence of erythema, cellulitis or systemically unwell
4. Treatment with biomedical/topical growth factors within previous 30 days
5. Previous history of an inability to tolerate compression therapy
6. Foot ulcer (i.e. below the ankle)
Previous exclusion criteria:
1. A diagnosis of sickle cell
2. Known sensitivities to any of the reagents/antibiotics listed on the DCD package insert
3. A clinically infected ulcer defined as evidence of erythema, cellulitis or systemically unwell
4. Treatment with biomedical/topical growth factors within previous 30 days
5. Previous history of an inability to tolerate compression therapy
6. Foot ulcer (i.e. below the ankle)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method