Diabetic Foot Ulcer Research Study
Research type
Research Study
Full title
A Pilot Open-Label Prospective, Randomised, Study to Evaluate the Safety and Efficacy of Keneric Healthcare RTD Wound Dressing in the Treatment of Diabetic Foot Ulcers Compared to Standard of Care
IRAS ID
325638
Contact name
Robin Kennedy
Contact email
Sponsor organisation
Keneric Healthcare
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
This study is to evaluate the safety and efficacy of the study wound dressing in the treatment of Diabetic Foot Ulcers when compared to standard of care.
The study’s purpose is to add UK specific data to the current technical and regulatory files as this product is already widely used as standard of care in East-Asia, South America and the USA.
Participants will be actively involved in the study for up to 12 weeks and will attend a their clinic a number of times within this period, the exact number will be determined on a case by case basis by their physician.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
23/ES/0017
Date of REC Opinion
10 May 2023
REC opinion
Unfavourable Opinion