Diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Current interventions as of 10/12/2019:
Phase II:
Participants are randomly allocated to one of five four groups, which may contain one, all, or a combination of the treatments. The treatments includ
Group 1: Treatment as usual (TAU)
Group 2: TAU + hydrosurgical debridement (HD)
Group 3: TAU + HD + decellularised dermal allograft (DCD)
Group 4: TAU + HD + DCD + NPWT
The randomised treatment strat
Sponsors
The Leeds Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/02/2022: 1. Aged =18 years 2. Diagnosis of Diabetes Mellitus (according to WHO criteria) 3. Has a chronic DFU or surgical debridement wound or open minor amputation and in the opinion of the attending clinical team is not on a healing trajectory despite usual best care for a minimum of 4 weeks since initial presentation at the MDT DFU service* 4.1 Ankle brachial index for the leg of the index ulcer =0.7 or non-compressible (measurements available in the participants notes taken within 3 months of randomisation can be used if no change in intervention or vascular events have occurred), OR 4.2 Toe brachial index =0.5 or opening toe pressure =50mmHg or non-compressible 5. Expected to comply with the treatment strategies and follow up schedule 6. Consent to foot and wound photography 7. Consent to participate (written/witnessed verbal informed consent) *Defined as failure to achieve >50% reduction in index ulcer area over a minimum of 4 weeks using local wound measurement policies _____ Previous inclusion criteria as of 10/12/2019: 1. Aged =18 years 2. Diagnosis of Diabetes Mellitus (according to WHO criteria) 3. Has a chronic DFU or surgical debridement wound or open minor amputation and in the opinion of the attending clinical team is not on a healing trajectory despite usual best care for a minimum of 4 weeks since initial presentation at the MDT DFU service* 4. Ankle brachial index for the leg of the index ulcer =0.7 or non-compressible (measurements available in the participants notes taken within 3 months of randomisation can be used if no change in intervention or vascular events have occurred) 5. Expected to comply with the treatment strategies and follow up schedule 6. Consent to foot and wound photography 7. Consent to participate (written/witnessed verbal informed consent) *Defined as failure to achieve >50% reduction in index ulcer area over a minimum of 4 weeks using local wound measurement policies _____ Previous inclusion criteria as of 22/11/2018: 1. Aged =18 years 2. Diagnosis of Diabetes Mellitus (according to WHO criteria) 3. Has a chronic DFU or surgical debridement wound or open minor amputation defined by either (a) OR (b) below: 3(a). Duration of = 12 weeks since initial presentation at the MDT DFU clinic and in the opinion of the attending clinical team is considered not to be on a healing trajectory despite usual best care† 3(b). Having <50% reduction in index ulcer area during a minimum period of 4 weeks prior to randomisation* 4. The index DFU has an area =0.8cm2 5. Ankle brachial index for the leg of the index ulcer =0.7 or non-compressible (measurements available in the participants notes taken within 3 months of randomisation can be used if no change in intervention or vascular events have occurred) 6. Expected to comply with the treatment strategies and follow up schedule 7. Consent to foot and wound photography 8. Consent to participate (written/witnessed verbal informed consent) † Participants who are eligible for randomisation under inclusion criteria 3(a) can be registered and randomised on the same day * Participants who are eligible for randomisation under inclusion criteria 3(b) will be randomised after a minimum 4 week suitability assessment period _____ Previous inclusion criteria from 07/09/2018 to 22/11/2018: 1. Aged =18 years 2. Diagnosis of Diabetes Mellitus (according to WHO criteria) 3. Has a chronic DFU or surgical debridement wound or open minor a
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 15/09/2017: 1. Has any current clinically infected DFU on the foot of the index ulcer (as per IDSA guidelines) 2. HbA1C> 110mmol/mol (measurements available in the participants notes taken within 3 months of randomisation can be used if no change in intervention or vascular events have occurred) 3. Estimated glomerular filtration rate (eGFR) 2 years (measurements taken within 3 months of randomisation can be used if no change in intervention or vascular events have occurred) 5. Planned or previous treatment with corticosteroids to an equivalent dose of prednisolone > 10mg per day or other immunosuppressive/immunomodulating therapy within 4 weeks prior to randomisation 6. Has evidence of connective tissue disorders as a cause of ulceration (e.g. vasculitis or rheumatoid arthritis) 7. Has evidence of dermatological disorders as a cause of ulceration (e.g. pyoderma gangrenosum or epidermolysis bullosa) 8. Planned or previous growth factor treatment within 4 weeks prior to randomisation 9. Planned or previous revascularisation or foot surgery affecting healing within the 4 weeks prior to randomisation 10. Index ulcer base has bone or joint involvement 11. Previously received DCD for the index ulcer within 4 weeks prior to randomisation 12. Previously received NPWT for the index ulcer within 4 weeks prior to randomisation 13. Previously received hydrosurgical or surgical debridement for the index ulcer within 4 weeks prior to randomisation 14. Has previously been randomised to the MIDFUT study 15. Unable to receive one or more of the randomised treatment strategies for any reason at the discretion of the attending clinical team (e.g. risk of excessive bleeding, serious falls risk, known allergies to NPWT dressings or dCELL dermis preparation components) Previous exclusion criteria: 1. Has any current clinically infected DFU (as per IDSA guidelines) 2. HbA1C> 110mmol/mol 3. Estimated glomerular filtration rate (eGFR) 2 years 5. Planned or previous treatment with corticosteroids to an equivalent dose of prednisolone > 10mg per day or other immunosuppressive therapy within 4 weeks prior to randomisation 6. Has evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis) and has planned or is under active treatment 7. Has evidence of dermatological disorders as a cause of ulceration (e.g. pyoderma gangrenosum or epidermolysis bullosa) 8. Planned or previous growth factor treatment within 4 weeks prior to randomisation 9. Planned or previous revascularisation or foot surgery affecting healing within the 4 weeks prior to randomisation 10. Index ulcer base has bone or joint involvement 11. Previously received DCD for the index ulcer within 4 weeks prior to randomisation 12. Previously received NPWT for the index ulcer within 4 weeks prior to randomisation 13. Previously received hydrosurgical or surgical debridement for the index ulcer within 4 weeks prior to randomisation 14. Has previously been randomised to the MIDFUT study 15. Lacks mental capacity and is unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II: Reduction in index ulcer area size is calculated using wound tracing grid and image J software measurements at baseline and week four. Phase III: Time to healing is the length of time from randomisation to the date the index ulcer is confirmed as healed by the blinded assessor. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: There are no secondary outcome measures: Phase III: 1. Healing status of the index ulcer is measured by clinical assessment at week two, four, 12, 20 and 52 2. Incidence of infection according to IDSA criteria will be recorded at week two, four, 12, 20 and 52 3. Time to re-ulceration following healing will be measured as the date the index ulcer is confirmed as healed by a blinded assessor to the date re-ulceration is confirmed by a blinded assessor 4. Quality of life is measured using the DFS-SF and the EQ-5D-5L questionnaires at week four, 12, 20, and 52 weeks post randomisation 5. Hospital admissions and amputations are measured using patient records at week four, 12, 20, 52 post randomisation 6. Cost effectiveness is measured using a health resource utilisation questionnaire at week four, 12, 20 and 52 post randomisation | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactRachael Gilberts
Outcome results
None listed