Status:
ACTIVE_NOT_RECRUITING
Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers
Lead Sponsor:
Hull University Teaching Hospitals NHS Trust
Conditions:
Diabetic Foot
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
Summary of the problem: Diabetes has been described as the fastest growing health crisis of our time. It currently affects more than 4.5million people in the UK. The direct cost to the NHS is already...
Detailed Description
There is an urgent need for better treatments for diabetic foot ulcers. Despite current best treatment, diabetic foot ulcers can be very difficult to heal, often taking months to heal and some never d...
Eligibility Criteria
Inclusion
- At least one unhealed diabetic foot ulcer below the level of the medial malleoli that has been present for more than 4 weeks
- Absolute toe pressure greater than or equal to 50mmHg or an Ankle Pressure Brachial Index (ABPI) equal to or greater than 0.7(24, 25)
- Capacity to consent to participate in the trial and given written informed consent
- Willing to be randomised to either sham, low-dose or high-dose ESWT
- Willing to consent to photography of the index DFU
- Willing to comply with the follow up schedule
Exclusion
- Interdigital index ulcer. This is because the ESWT delivery paddle does not fit between digits.
- Currently on or planned treatment for osteomyelitis.
- Currently taking any therapeutic anticoagulation medications. This includes novel oral anticoagulants, therapeutic doses of heparin and vitamin-K antagonists. This is a contraindication to ESWT.
- Diagnosis of malignancy in the treatment area or haematological, disseminated or lymphatic malignancy. This is a contraindication to ESWT.
- All who are pregnant, trying to conceive or breastfeeding. This is a contraindication to ESWT.
- Active participants in other trials that may conflict with the study outcomes, for example any other wound care trials.
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2032
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT05380544
Start Date
April 13 2022
End Date
May 1 2032
Last Update
October 2 2024
Active Locations (1)
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1
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom, HU3 2JZ