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

Condition(s) studied

Investigational drug(s) / intervention(s)

Cold atmospheric plasma (CAP): CAP therapy will be administered once daily for the first five days and then every other day thereafter, for a total of 13 sessions. Each session will last approximately 25 minutes, as recommended by the manufacturer. During treatment, the affected limb will be enclosed in a sterile treatment bag, sealed with medical adhesive tape. The CAP device will operate in two sequential modes: a "disinfection mode" delivering ozone-rich (O₃) plasma-activated gas for 20 minutes, followed by a "healing mode" delivering nitric oxide (NO)-rich plasma-activated gas for 5 minutes. All procedures will be performed in accordance with the manufacturer's instructions and the device's standard operating protocol.

Sham Procedure: Participants in the placebo group will undergo a sham procedure, in which the electric field required for plasma generation will be disabled, so that no plasma will be produced. Only the operating sounds of the device will be simulated, ensuring blinding for both participants and clinical staff.

Successful infrapopliteal angioplasty: All patients will undergo successful infrapopliteal angioplasty, with less than 30% residual stenosis confirmed by digital subtraction angiography.

Study 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

Primary outcome measure(s)

• Change in ulcer area between groups — From Baseline (Day 0) to Day 21 post-randomization
  The ulcer area (cm²) will be measured daily during the first five days, and every other day for the subsequent eight visits (13 follow-up assessments in total)

Trial sites (1)

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