Actively Recruiting
Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion
Led by Shenyang Medical College · Updated on 2026-04-22
40
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
Sponsors
S
Shenyang Medical College
Lead Sponsor
A
Ansteel Group General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 18 to 80 years with diabetic foot ulcers (DFUs) complicated by lower extremity arterial occlusion. The main questions it aims to answer are: 1. Does CAP treatment lead to a greater reduction in ulcer area by Week 4 compared to placebo?; 2. Is CAP therapy safe and well-tolerated in patients with DFUs after successful infrapopliteal revascularisation?; Researchers will compare CAP treatment plus standard care to sham CAP (placebo) plus standard care to see if CAP improves wound healing more effectively and reduces adverse local symptoms. Participants will: 1. Receive either active CAP therapy or sham CAP therapy once daily for 10 days following endovascular revascularisation 2. Undergo daily wound assessments for ulcer area, signs of infection, and pain scores 3. Complete quality-of-life questionnaires (EQ-5D and SF-12) at baseline and Week 4 4. Be followed through Week 4 to assess efficacy and safety endpoints
CONDITIONS
Official Title
Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years with type 1 or type 2 diabetes and HbA1c 6410%
- Presence of at least one chronic foot ulcer lasting 3 weeks or more, classified as Wagner-Armstrong grade 1D or 2D, with no healing despite standard care
- Imaging-confirmed infrapopliteal arterial stenosis or occlusion; successful infrapopliteal balloon angioplasty with 6430% residual stenosis confirmed intraoperatively
- Signed written informed consent prior to participation
You will not qualify if you...
- Current use of negative pressure wound therapy (NPWT) or maggot debridement therapy
- Undergoing dialysis for end-stage renal disease
- Use of topical antibiotics with known biological activity on the wound
- Use of platelet-rich fibrin (PRF) for wound treatment
- Women of childbearing potential without effective contraception or currently breastfeeding
- Severe comorbidities with life expectancy less than 6 months
- Participation in another clinical trial within the past 3 months or currently enrolled in another study
- Any condition deemed unsuitable for trial participation by the investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ansteel Group General Hospital
Anshan, Liaoning, China, 114003
Actively Recruiting
Research Team
Y
Yun-En Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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