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

Condition(s) studied

Investigational drug(s) / intervention(s)

Cold Atmospheric Plasma (CAP): CAP-activated gas treatment developed by Xi'an Jiaotong University (Chinese patent No. ZL202110209052.X); administered once daily for 10 days, 25 minutes per session.

Sham CAP Therapy: Identical equipment without plasma activation; simulates treatment environment (sound, airflow) for participant blinding.

Infrapopliteal Endovascular Revascularisation: Balloon angioplasty is performed on infrapopliteal arteries with significant stenosis or occlusion. Technical success is defined as \<30% residual stenosis, confirmed intraoperatively by digital subtraction angiography (DSA). Only patients with successful revascularisation are eligible for randomisation.

Guideline-Based Standard DFU Care: All participants will receive diabetic foot ulcer (DFU) care according to current international and Chinese clinical guidelines

Study summary

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

Eligibility

Primary outcome measure(s)

• Change in ulcer area (cm²) — assessed at baseline, Day 1 to Day 10 post-randomisation, and at Week 4
  Ulcer area will be measured at baseline, daily from Day 1 to Day 10, and at Week 4 post-randomisation. Measurements are obtained from calibrated wound photographs and analysed using ImageJ software. Primary endpoint will be analysed using a linear mixed-effects model to evaluate differences between groups over time.

Trial sites (1)

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