Status:
RECRUITING
Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion
Lead Sponsor:
Shenyang Medical College
Collaborating Sponsors:
Ansteel Group General Hospital
Conditions:
Diabetic Foot Ulcers (DFU)
Lower Extremity Arterial Occlusion
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate whether cold atmospheric plasma (CAP) combined with endovascular intervention can accelerate wound healing and improve safety outcomes in patients aged 1...
Detailed Description
Diabetic foot ulcers (DFUs) complicated by lower extremity arterial occlusion are difficult to heal, even after successful endovascular revascularisation, due to persistent microcirculatory impairment...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07198061
Start Date
October 9 2025
End Date
March 30 2026
Last Update
November 18 2025
Active Locations (1)
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1
Ansteel Group General Hospital
Anshan, Liaoning, China, 114003