Diabetic Foot Ulcers Study
Research type
Research Study
Full title
An Open Label, Randomised Study to Evaluate the Keneric Healthcare RTD Wound Dressing in the Treatment of Diabetic Foot Ulcers Compared to Standard of Care Dressings.
IRAS ID
329882
Contact name
Duncan Stang
Contact email
Sponsor organisation
Keneric Healthcare
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 8 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 purpose of the study is to add UK specific data on the comparative efficacy, safety and tolerability of Keneric RTD Wound Dressing in the treatment of diabetic foot ulcers. This is primarily to generate local data that would support the addition of the RTD dressing to the drug tariff and to local NHS formularies, by demonstrating its acceptability as a standard of care dressing for the treatment of diabetic foot ulcers in NHS practice. 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 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/0024
Date of REC Opinion
17 Jul 2023
REC opinion
Further Information Favourable Opinion