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

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

Conditions

• Diabetic Foot Ulcers (DFU)
• Lower Extremity Arterial Occlusion

Interventions

DEVICE

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.

DEVICE

Sham CAP Therapy

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

PROCEDURE

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.

OTHER

Guideline-Based Standard DFU Care

All participants will receive diabetic foot ulcer (DFU) care according to current international and Chinese clinical guidelines

Sponsors & Collaborators

• Ansteel Group General Hospital

  collaborator UNKNOWN

• Shenyang Medical College

  lead OTHER

Principal Investigators

• Yun-En Liu, MD · Shenyang Medical College

• Lin Tao, MM · Shenyang Medical College

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-09

Primary Completion

2026-11-20

Completion

2026-12-30

Countries

• China

Study Locations