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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-09

Study Completion Date

2026-03-30

Brief Summary

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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

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Detailed Description

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Diabetic foot ulcers (DFUs) complicated by lower extremity arterial occlusion are difficult to heal, even after successful endovascular revascularisation, due to persistent microcirculatory impairment and chronic inflammation. Cold atmospheric plasma (CAP) has shown promising effects in promoting wound healing through antimicrobial activity, angiogenesis induction, and modulation of inflammatory responses. However, its efficacy and safety in the clinical treatment of DFUs remain to be validated in randomized controlled trials.

This prospective, randomized, placebo-controlled, single-center clinical trial aims to assess the efficacy and safety of CAP therapy, delivered as CAP-activated gas, in patients with DFUs who have undergone successful infrapopliteal balloon angioplasty. Participants will receive either active or sham CAP therapy once daily for 10 days, in addition to standard DFU care. The primary endpoint is the percentage reduction in ulcer area at Week 4. Secondary outcomes include time to early healing response, pain scores, quality of life, and local adverse events.

The results of this study are expected to provide clinical evidence supporting the use of CAP as an adjunctive therapy in ischemic diabetic foot wound management.

Conditions

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Diabetic Foot Ulcers (DFU) Lower Extremity Arterial Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Cold Atmospheric Plasma (CAP) Group

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

Group Type EXPERIMENTAL

Cold Atmospheric Plasma (CAP)

Intervention Type 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.

Infrapopliteal Endovascular Revascularisation

Intervention Type 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.

Guideline-Based Standard DFU Care

Intervention Type OTHER

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

Sham CAP (Placebo) Group

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

Group Type PLACEBO_COMPARATOR

Sham CAP Therapy

Intervention Type DEVICE

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

Infrapopliteal Endovascular Revascularisation

Intervention Type 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.

Guideline-Based Standard DFU Care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

Sham CAP Therapy

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

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Guideline-Based Standard DFU Care

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 1)Age between 18 and 80 years; diagnosed with type 1 or type 2 diabetes mellitus; with HbA1c ≤10%;
* 2)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;
* 3)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);
* 4)Signed written informed consent prior to study participation.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No