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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT03085550
Eligibility Criteria:
Inclusion Criteria:
* Male or female;
* Age 18-90 at the time of consent;
* Diabetic foot ulcer (DFU) measuring more than 0.5cm x 0.5cm and less than 10cm x 10cm;
* Wound with clean, healthy granulating bed, with minimal adherent slough;
* Patient understands and is willing to participate and can comply with weekly visits and follow-up regime.
Exclusion Criteria:
* Wound with active infection;
* Patients with underlying vascular insufficiency (ABPI\<0.3);
* Uncontrolled Diabetes Mellitus, as measured by an HbA1c \> 90mmol/mol;
* Presence of one or more medical conditions, including renal, hepatic, haematologic, active auto-immune or immune diseases that, would make the subject an inappropriate candidate for this ulcer healing study;
* Patient not fit for surgery (ASA classification \> 4).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03085550
Study Brief:
Protocol Section:
NCT03085550