Status:
UNKNOWN
Moleculight i:X™ in Wound Healing
Lead Sponsor:
The Leeds Teaching Hospitals NHS Trust
Conditions:
Ulcer Foot
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Diabetic foot disease is a global health problem. Diabetes affects over 450million people worldwide, expected to rise to 1 in 10 people by 2040. 60-70% will lose sensation in their feet and up to 25% ...
Eligibility Criteria
Inclusion
- Aged ≥ 18 years
- Diagnosis of Diabetes (according to WHO criteria)
- Has ulceration of the foot below the malleoli
- Expected to comply with the treatment strategies and follow up schedule
- Consent to foot and wound photography
- Consent to participate (written/witnessed verbal consent)
Exclusion
- Has any current clinically infected diabetic foot ulcer (as per IDSA guidelines).
- Estimated glomerular filtration rate (eGFR) \<20mL/min/1.73m2 (measurements taken within 3 months of randomisation can be used if no change in intervention or vascular events have occurred)
- Has ABPI \<0.5 or opening toe pressure \<30mmHg (measured within 3 months of randomisation)
- 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
- Has evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis) and has planned or is under active treatment.
- Has evidence of dermatological disorders (e.g. pyoderma gangrenosum or epidermolysis bullosa)
- Has previously been randomised to the Moleculight i:X™ study
- Lacks mental capacity and is unable to provide informed consent.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03270904
Start Date
December 1 2017
End Date
August 31 2018
Last Update
January 24 2018
Active Locations (1)
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1
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom