Debrisoft and healing
Research type
Research Study
Full title
A pilot study comparing venous leg ulcer healing with and without the use of Debrisoft to debride the wounds.
IRAS ID
263039
Contact name
Clare Morris
Contact email
Sponsor organisation
Lohmann & Rauscher Medical (UK) Ltd
Clinicaltrials.gov Identifier
EudraCT number , 2019-002313-19
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
This pilot randomized controlled study to assess the effectiveness and cost-effectiveness of Debrisoft on venous leg ulcers (VLU). 50 evaluable patients (25 each arm) with VLUs will be identified from outpatient & community wound clinics.
Patients meeting the inclusion and exclusion criteria will be consented and will visit the research facility once a week for 2 weeks prior to randomisation at Week 2.
Patients who do not meet the randomisation criteria (their study wound has decreased in size greater than 20%) at Week 2 will end their participation at this point.
Patients who do meet the randomisation criteria (study wound has NOT decreased in size greater than 20%) at Week 2 will be randomised to either Standard of Care (SOC) with Debrisoft, or SOC alone with treatment provided as required to achieve debridement.
Patients will visit the research facility 3 times at week 2 then twice a week for 3 weeks then weekly for 7 weeks with a final visit at Week 13. Questionnaires will be completed during 3 visits.
At the first of each weekly visit the wound will be assessed and photographed. A blinded assessor will determine whether complete debridement and healing has been achieved.
The first 10 randomised subjects will undergo non-invasive blood flow measurement at the Welsh Wound Innovation Centre, transportation will be provided.Both groups will continue with the allocated treatment until the ulcer heals or until study end, whichever is soonest. Longer term follow-up will be performed using questionnaires at the patients routine NHS appointment at 6 months and a telephone call after 1 year.
As this study is also looking at difference in cost between treatments, authorised personnal from Swansea University will spend time at the NHS clinic and collect a history of previous treatments for the study wound from the patients hospital records (nursing assessments).
REC name
Wales REC 5
REC reference
19/WA/0248
Date of REC Opinion
2 Oct 2019
REC opinion
Further Information Favourable Opinion