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 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT07198061
Eligibility Criteria:
Inclusion Criteria:
* 1)Age between 18 and 80 years; diagnosed with type 1 or type 2 diabetes mellitus; with HbA1c ≤10%;
* 2)Presence of at least one chronic foot ulcer persisting for ≥3 weeks, with no signs of healing despite guideline-directed standard care; ulcer classified as Wagner-Armstrong grade 1D or 2D;
* 3)Imaging-confirmed infrapopliteal arterial stenosis or occlusion, assessed by vascular ultrasound and/or computed tomography angiography (CTA); all patients must have undergone infrapopliteal balloon angioplasty, with successful target vessel revascularisation confirmed intraoperatively (≤30% residual stenosis);
* 4)Signed written informed consent prior to study participation.
Exclusion Criteria:
* 1)Concurrent use of negative pressure wound therapy (NPWT) or maggot debridement therapy;
* 2)Undergoing dialysis for end-stage renal disease;
* 3)Use of topical antibiotics with known biological activity on the wound;
* 4)Use of platelet-rich fibrin (PRF) for wound treatment;
* 5)Women of childbearing potential without effective contraception, or currently breastfeeding;
* 6)Presence of severe comorbidities involving other organ systems, with an estimated life expectancy of less than 6 months;
* 7)Participation in another clinical trial within the past 3 months, or currently enrolled in another clinical study;
* 8)Any condition deemed unsuitable for trial participation at the discretion of the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07198061
Study Brief:
Protocol Section:
NCT07198061