NCT07073040 Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention in Patients With Diabetic Foot Ulcers and Lower Extremity Arterial Occlusion

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This trial targets 86 participants in total. It began in 2025-07-22 with a primary completion date of 2026-04-10.

Brief Summary

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, and tissue repair deficits. Current advanced wound dressings provide limited benefit and are often costly. Cold atmospheric plasma (CAP) has emerged as a promising adjunctive therapy, with demonstrated antimicrobial activity-including efficacy against multidrug-resistant organisms-and the ability to promote microcirculation and wound healing. CAP generates reactive oxygen and nitrogen species that disrupt bacterial membranes and may also stimulate tissue regeneration. Preclinical and clinical studies suggest that CAP can accelerate healing in chronic wounds and is well tolerated by patients. Given these advantages, the present study aims to assess the efficacy and safety of CAP combined with endovascular intervention in patients with diabetic foot ulcers and lower extremity arterial occlusion, to inform future clinical application of this novel technology.

Eligibility Criteria

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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