Dermagraft 001-08
Research type
Research Study
Full title
A Prospective, multi-centre, randomised, controlled clinical investigation of Dermagraft in studies with venous leg ulcers DEVO-Trial
IRAS ID
21141
Contact name
Keith Harding
Contact email
Eudract number
2009-010062-33
ISRCTN Number
0000000000000
Clinicaltrials.gov Identifier
0000000000000
Research summary
The main purpose of the study is to assess the safety and effectiveness of Dermagraft© (a tissue engineered skin replacement) and compression bandaging, in the promotion of healing hard to heal venous leg ulcers compared with conventional therapy (compression bandaging alone). Venous leg ulcers are a common problem and research suggests that 1% of the adult population has or may suffer from ulceration during their life time. A chronic venous ulcer is associated with impaired circulation in the superficial and/or deep veins which run within the muscles of the leg. Venous ulcers can be difficult to heal; typical time to healing is between 12-30 weeks. Compression bandaging combined with appropriate wound care is the standard treatment. Open venous ulcers can be incapacitating because of copious drainage, infection and pain. Patients over the age of 18, who have a venous leg ulcer as diagnosed by their doctor, who meets all the inclusion criteria, will be included. The ulcer has to have been present for at least one month but no more than 24 months.. The study is being conducted in 40 research centres in UK, US, Estonia, Sweden, Germany, Poland, Austria and South Africa. The study will run for approximately two year through all countries. Participants will, after informed consent has been given, undergo a medical examination and blood samples will be taken for analysis, photographs, tracings and measurements will be taken of the ulcer. The ulcer will have dead tissue removed at each visit and will receive either treatment with the study product or standard compression according to the group to which they have been randomised (randomisation will be carried out by a computer generated number giving a 50/50 chance of treatment with the study product or standard compression). Participants will be followed up weekly for 16 weeks with an additional visit post study for safety.
REC name
Wales REC 3
REC reference
09/MRE09/37
Date of REC Opinion
18 Aug 2009
REC opinion
Further Information Favourable Opinion