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

RecruitingNAAges 18 Years - 80 YearsAllShenyang Medical College
NCT07073040 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Critical limb ischemia is the end-stage manifestation of peripheral arterial disease (PAD), frequently presenting as ischemic rest pain, ulceration, or gangrene. Diabetes mellitus is a major risk factor for lower extremity arterial occlusion, with infrapopliteal arteries most commonly affected. Patients with diabetic foot ulcers (DFUs) have a high prevalence of neurovascular complications, poor healing, and elevated amputation and mortality rates. Large-scale cohort studies indicate that five-year survival after amputation in this population is only about 50%, underscoring the need for more effective therapies. Endovascular revascularization has become the first-line treatment for diabetic lower limb ischemia. However, despite successful revascularization, persistent microvascular dysfunction and difficult-to-heal ulcers remain common due to chronic inflammation, impaired angiogenesis,

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged 18-80 years, with a diagnosis of type 1 or type 2 diabetes and diabetic foot ulcer; glycated hemoglobin (HbA1c) ≤ 10%. * Presence of at least one chronic foot ulcer persisting for at least three weeks, with no signs of healing after standard-of-care treatment based on current clinical guidelines. The ulcer must be classified as Wagner-Armstrong grade 1D or 2D (Wagner: superficial ulcer \[grade 1\] or ulcer extending to tendon \[grade 2\]; Armstrong: presence of both ischaemia and infection \[stage D\]). * Documented infrapopliteal arterial stenosis or occlusion by vascular ultrasound and/or CT angiography (CTA), meeting indications for revascularization. All enrolled patients must have received successful infrapopliteal balloon angioplasty, with intraoperative angiography confirming target artery patency. * Provision of written informed consent. Exclusion Criteria: * Concurrent treatment of the wound with local vacuum therapy or maggot therapy. * Undergoing dialysis. * Use of local active antibiotics. * Treatment with platelet-rich fibrin. * Women of childbearing potential without effective contraception, or women who are actively breastfeeding. * Presence of other severe organ dysfunction, with an expected survival of less than six months. * Participation in another clinical trial within the past three months or currently enrolled in another clinical trial.
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What it tests

  • Cold atmospheric plasma (CAP)
  • Sham Procedure
  • Successful infrapopliteal angioplasty
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Where

1 site
Ansteel General Hospital
Anshan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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