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

NCT07198061 | Recruiting DMC

• 1 other identifier: CAP_Foot_Ulcers
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does CAP treatment lead to a greater reduction in ulcer area by Week 4 compared to placebo?;
2. 2.Is CAP therapy safe and well-tolerated in patients with DFUs after successful infrapopliteal revascularisation?;
3. 3.Receive either active CAP therapy or sham CAP therapy once daily for 10 days following endovascular revascularisation
4. 4.Undergo daily wound assessments for ulcer area, signs of infection, and pain scores
5. 5.Complete quality-of-life questionnaires (EQ-5D and SF-12) at baseline and Week 4
6. 6.Be followed through Week 4 to assess efficacy and safety endpoints

Conditions

Diabetic Foot Ulcers (DFU); Lower Extremity Arterial Occlusion

Keywords

Cold Atmospheric Plasma; Diabetic Foot Ulcers; lower extremity arterial occlusion

Outcome Measures

Primary Outcomes (1)

• Change in ulcer area (cm²)

  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.

  assessed at baseline, Day 1 to Day 10 post-randomisation, and at Week 4

Secondary Outcomes (4)

• Time to 10% reduction in ulcer area

  From baseline through Day 10 and Week 4 post-randomisation

• Mean change in pain score measured by Visual Analogue Scale (VAS)

  Baseline; daily from Day 1 to Day 10; and at Week 4 post-randomisation

• Change in quality of life (EQ-5D)

  Baseline and Week 4 post-randomisation

• Change in quality of life (SF-12)

  Baseline and Week 4 post-randomisation

Other Outcomes (3)

• Incidence of skin irritation

  Daily from baseline to Day 10 and at Week 4 post-randomisation

• Incidence of local bleeding

  Daily from baseline to Day 10 and at Week 4 post-randomisation

• Incidence of local burning sensation

  Daily from baseline to Day 10 and at Week 4 post-randomisation

Study Arms (2)

Cold Atmospheric Plasma (CAP) Group

EXPERIMENTAL

Participants with diabetic foot ulcers (DFUs) and infrapopliteal arterial occlusion who receive CAP therapy once daily for 10 days following successful endovascular intervention.

Device: Cold Atmospheric Plasma (CAP); Procedure: Infrapopliteal Endovascular Revascularisation; Other: Guideline-Based Standard DFU Care

Sham CAP (Placebo) Group

PLACEBO COMPARATOR

Participants with DFUs and infrapopliteal arterial occlusion who receive sham CAP therapy with an identical-looking device that does not produce active plasma.

Device: Sham CAP Therapy; Procedure: Infrapopliteal Endovascular Revascularisation; Other: Guideline-Based Standard DFU Care

Interventions

Sham CAP Therapy DEVICE

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

Sham CAP (Placebo) Group

Infrapopliteal Endovascular Revascularisation PROCEDURE

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.

Cold Atmospheric Plasma (CAP) Group; Sham CAP (Placebo) Group

Guideline-Based Standard DFU Care OTHER

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

Cold Atmospheric Plasma (CAP) Group; Sham CAP (Placebo) Group

Cold Atmospheric Plasma (CAP) DEVICE

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.

Cold Atmospheric Plasma (CAP) Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• )Age between 18 and 80 years; diagnosed with type 1 or type 2 diabetes mellitus; with HbA1c ≤10%;
• )Presence of at least one chronic foot ulcer persisting for ≥3 weeks, with no signs of healing despite guideline-directed standard care; ulcer classified as Wagner-Armstrong grade 1D or 2D;
• )Imaging-confirmed infrapopliteal arterial stenosis or occlusion, assessed by vascular ultrasound and/or computed tomography angiography (CTA); all patients must have undergone infrapopliteal balloon angioplasty, with successful target vessel revascularisation confirmed intraoperatively (≤30% residual stenosis);
• )Signed written informed consent prior to study participation.

You may not qualify if:

• )Concurrent use of negative pressure wound therapy (NPWT) or maggot debridement therapy;
• )Undergoing dialysis for end-stage renal disease;
• )Use of topical antibiotics with known biological activity on the wound;
• )Use of platelet-rich fibrin (PRF) for wound treatment;
• )Women of childbearing potential without effective contraception, or currently breastfeeding;
• )Presence of severe comorbidities involving other organ systems, with an estimated life expectancy of less than 6 months;
• )Participation in another clinical trial within the past 3 months, or currently enrolled in another clinical study;
• )Any condition deemed unsuitable for trial participation at the discretion of the investigators.

Sponsors & Collaborators

• Shenyang Medical College: lead
• Ansteel Group General Hospital: collaborator

Study Sites (1)

Ansteel Group General Hospital

Anshan, Liaoning, 114003, China

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Yun-En Liu, MD

  Shenyang Medical College

  STUDY CHAIR

• Lin Tao, MM

  Shenyang Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-En Liu, MD

CONTACT

86-24-62215130; lye9901@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: To preserve procedural blinding, participants in the placebo group will undergo a simulated intervention using an identical device setup, with the plasma-generating electric field disabled. The system will mimic the treatment session environment (including operating sounds and airflow) without producing active plasma or gas.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: This is a two-arm, parallel-assignment, randomized controlled trial. Participants are randomly assigned in a 1:1 ratio to receive either cold atmospheric plasma (CAP) therapy or sham CAP therapy, in addition to standard diabetic foot ulcer care. Both groups receive 10 treatment sessions over 10 consecutive days. The trial includes blinded outcome assessment and sham control procedures to preserve participant blinding.

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: September 30, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)