Comparing treatments for diabetic foot ulcers
- Conditions
- Diabetes mellitusNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN64926597
- Lead Sponsor
- The Leeds Teaching Hospitals NHS Trust
- Brief Summary
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32312727/ (added 19/10/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 213
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 inf
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) < 20mL/min/1.73m2
4. Index ulcer duration > 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) < 20mL/min/1.73m2
4. Index ulcer duration > 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 ulce
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Phase II:<br> Reduction in index ulcer area size is calculated using wound tracing grid and image J software measurements at baseline and week four.<br><br> Phase III:<br> Time to healing is the length of time from randomisation to the date the index ulcer is confirmed as healed by the blinded assessor.<br>
- Secondary Outcome Measures
Name Time Method