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.Lay summary of study results: Multiple Interventions of Diabetic Foot Ulcer Treatment trial (MIDFUT) was sponsored by Leeds Teaching Hospitals NHS Trust and funded by NIHR HTA (grant number 15/08/77). The study recruited from April 2017 to end of August 2025 across 35 hospitals in England and Scotland.
Diabetes affects 5 million people in the UK, and approximately 25% of them will develop a Diabetic Foot Ulcer (DFU) in their lifetime. This costs the NHS over £1billion a year in DFU treatments, and they negatively impact patient quality of life. There are treatments available, but these come at a high cost and have a lack of robust evidence. Trialling three treatments for DFUs separately would be time consuming and expensive, so this trial used a multi-arm, multi-stage design to be more efficient and cost-effective. The aim was to assess the use of hydrosurgical debridement alone or in combination with negative pressure wound therapy and/or decellularised skin graft from organ donors in the treatment of hard to heal diabetic foot ulcers. These devices and their use were compared in combination with treatment as usual. 213 participants were recruited, who were adults with a diagnosis of diabetes with a chronic diabetic foot ulcer. The treatments they received were treatment as usual (TAU), which was standard care in line with NICE (NG19) Guidelines. This includes but is not limited to checking the ulcer often, removal of hard skin, wound dressings, footwear to reduce pressure, and diabetes management advice. Hydrosurgical debridement (HD) is a device that uses a high-pressure jet of water to create a vacuum which helps take away dead skin and tissue from the ulcer. Decellularised Dermal Allograft (DCD) is a skin graft made from donated human skin with the cells removed. Both HD and DCD were one off treatments performed in the hospital outpatient clinic. Negative Pressure Wound Therapy (NPWT) uses a dressing on the ulcer covered with a waterproof layer. The dressing is attached to a pump which sucks fluid away from the ulcer. This is left in place for 2 weeks (but the dressing is changed during this time). Participants were randomised to i) TAU and HD. ii) TAU with HD and DCD. iii) TAU with HD, DCD and 2 weeks of NPWT iv) TAU (control). Patients were followed for up to 52 weeks post randomisation, with follow up assessments at Week 1, 2, 4, 8, 12, 20 and 52. They would also complete questionnaires about their quality of life. If participants ulcers were reported as healed, as blinded assessor would do an ad-hoc confirmation visit within 3 days. Our patient population often had health problems relating to the diabetes itself, or other conditions due to their age and general poor health, rather than the interventions. This included amputation and infections. Problems relating to the treatments often involved some discomfort around application.
The study was affected by the COVID-19 pandemic, and this meant we had problems recruiting. We were able to complete the study to show whether any of the trial treatments showed a signal of improved wound healing above TAU alone.
The results of the study showed that none of the treatment strategies were more effective than the control arm, but none of the study treatments had a negative impact on participant health. Having a treatment did not mean that you healed more quickly. This means the current standard of care for diabetic ulcer treatment is at least as good as any of these interventions. The treatments we tested cost the NHS extra money to carry out, so it means we don’t need to spend extra money to get the best outcomes for patients. The study has shown that we should not be using any of the study interventions in current clinical practice. Whilst it does not improve diabetic foot ulcer healing, it will save the NHS money and prevent patients having treatments that don’t improve outcomes.There was 2 Patient & Public Involvement (PPI) representatives on our Study Steering Committee who both had lived experience with diabetes, one also with diabetic foot ulcers. They had regular input at meeting, and contributed to delivery of the study, including how to address challenges with recruitment, improving questionnaire response rates and trial specific public dissemination through diabetes UK and regional diabetes public forums. Two other participants provided specific input, one in terms of a patient story for public dissemination, and one who attended a study investigator meeting to provide feedback on the trial and help model optimal approaches when approaching potential participants for the study.
There is no further work planned on the basis of this study.
You can learn more on our website https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fctru.leeds.ac.uk%252Fmidfut%252F%2FNBTI%2FNDnBAQ%2FAQ%2F12edc0a5-fe55-41d1-bfd0-fd81a52ea5f9%2F2%2F_3hCwqdwdt&data=05%7C02%7Cbradfordleeds.rec%40hra.nhs.uk%7C02411caeef50427042b908de1e14f74e%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638981272554000304%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=wtF4aPOs%2F9v4XeMVOfrCq7DrMP63u1%2BHNqtoY4lZMRA%3D&reserved=0 or on the ISRCTN registry (ISRCTN64926597).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