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Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion

RecruitingNAAges 18 Years - 80 YearsAllShenyang Medical College
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In plain words

What the trial is, and whether it could suit you

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 dai

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 1)Age between 18 and 80 years; diagnosed with type 1 or type 2 diabetes mellitus; with HbA1c โ‰ค10%; * 2)Presence of at least one chronic foot ulcer persisting for โ‰ฅ3 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 (โ‰ค30% 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.
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What it tests

  • Cold Atmospheric Plasma (CAP)
  • Sham CAP Therapy
  • Infrapopliteal Endovascular Revascularisation
  • Guideline-Based Standard DFU Care
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Where

1 site
Ansteel Group General Hospital
Anshan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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