Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-24 @ 8:00 PM
NCT ID:
NCT03270904
Eligibility Criteria:
Inclusion Criteria:
1. Aged ≥ 18 years
2. Diagnosis of Diabetes (according to WHO criteria)
3. Has ulceration of the foot below the malleoli
4. Expected to comply with the treatment strategies and follow up schedule
5. Consent to foot and wound photography
6. Consent to participate (written/witnessed verbal consent)
Exclusion Criteria:
1. Has any current clinically infected diabetic foot ulcer (as per IDSA guidelines).
2. 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)
3. Has ABPI \<0.5 or opening toe pressure \<30mmHg (measured within 3 months of randomisation)
4. 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
5. Has evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis) and has planned or is under active treatment.
6. Has evidence of dermatological disorders (e.g. pyoderma gangrenosum or epidermolysis bullosa)
7. Has previously been randomised to the Moleculight i:X™ study
8. Lacks mental capacity and is unable to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03270904
Study Brief:
Protocol Section:
NCT03270904