MIDFUT
Research type
Research Study
Full title
Multiple Interventions of Diabetic Foot Ulcer Treatment Trial
IRAS ID
215194
Contact name
David Russell
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
This study is looking into the best way to treat chronic diabetic foot ulcers (DFUs). There are a number of treatments used in the NHS but there is limited evidence on which combination of these works best at helping to heal DFUs. The study is funded by the National Institute of Health Research’s Health Technologies Assessment (HTA) programme and will evaluate the use of the following treatments:
- Hydrosurgical debridement (HD): A once only treatment with a device which uses a stream of water to help remove dead skin.
- Negative pressure wound therapy (NPWT): A pump which is attached to the foot and uses suction via a sealed dressing to remove fluid. This treatment is left in place for up to 2 weeks.
- Decellularised dermal allograft (DCD): A type of human skin graft which does not contain any cells and is applied once to the wound.
The study will compare combinations of these treatments in addition to treatment as usual (TAU) to TAU alone.
The trial is multi-arm multi-stage and in Phase II of the study participants will be randomised to receive one of the following treatment strategies;
- TAU
- TAU + HD
- TAU + HD + NPWT
- TAU + HD + DCD
- TAU + HD + DCD + NPWT
A maximum of two treatment strategies showing the greatest evidence of efficiency during Phase II will continue into Phase III with TAU.
To enter the trial patients must be over 18, have been diagnosed with diabetes and have a chronic DFU which has not reduced in area by 40% in 4 weeks. Recruitment, treatment and follow up assessments at 1, 2, 4, 12, 20 and 52 weeks will be carried out within at least 24 clinics providing a multidisciplinary DFU service in the UK.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
17/YH/0055
Date of REC Opinion
26 Apr 2017
REC opinion
Further Information Favourable Opinion