Diabetic Foot Ulcers (DFU)NCT07198061
Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion
A study testing Cold Atmospheric Plasma (CAP), Infrapopliteal Endovascular Revascularisation and Guideline-Based Standard DFU Care in people with Diabetic Foot Ulcers (DFU) and Lower Extremity Arterial Occlusion, run by Shenyang Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcers (DFU), Lower Extremity Arterial Occlusion
- What is being tested?
- Cold Atmospheric Plasma (CAP), Infrapopliteal Endovascular Revascularisation and Guideline-Based Standard DFU Care
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ansteel Group General Hospital
Anshan, Liaoning, 114003
Dong-Ming Ren, MD, 86-13352107771, rendongminganshan@163.com
Dong-Ming Ren, MD
About this study
Official title: Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion: A Randomized, Double-Blind, Placebo-Controlled Trial
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:
Read more
- Does CAP treatment lead to a greater reduction in ulcer area by Week 4 compared to placebo?;
- 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:
- Receive either active CAP therapy or sham CAP therapy once daily for 10 days following endovascular revascularisation
- Undergo daily wound assessments for ulcer area, signs of infection, and pain scores
- Complete quality-of-life questionnaires (EQ-5D and SF-12) at baseline and Week 4
- Be followed through Week 4 to assess efficacy and safety endpoints
Read the detailed description
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.
- Being tested
- Cold Atmospheric Plasma (CAP), Sham CAP Therapy, Infrapopliteal Endovascular Revascularisation, Guideline-Based Standard DFU Care
- Keywords
- Cold Atmospheric Plasma, Diabetic Foot Ulcers, lower extremity arterial occlusion
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sham CAP TherapyDevice
Identical equipment without plasma activation; simulates treatment environment (sound, airflow) for participant blinding.
Infrapopliteal Endovascular RevascularisationProcedure or surgery
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 CareOther
All participants will receive diabetic foot ulcer (DFU) care according to current international and Chinese clinical guidelines
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham CAP Therapy; Procedure: Infrapopliteal Endovascular Revascularisation; Other: Guideline-Based Standard DFU Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: assessed at baseline, Day 1 to Day 10 post-randomisation, and at Week 4
Secondary outcomes (4)
Time to 10% reduction in ulcer area
The time (in days) from baseline to the first documentation of ≥10% reduction in ulcer surface area compared to baseline, as measured by calibrated wound photography analysed using ImageJ software. Ulcer size is measured daily from Day 1 to Day 10 and at Week 4.
Measured: From baseline through Day 10 and Week 4 post-randomisation
Mean change in pain score measured by Visual Analogue Scale (VAS)
Pain severity will be assessed using the 10-point Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. Measurements will be taken at baseline, daily from Day 1 to Day 10, and at Week 4 post-randomisation. Change in VAS score over time will be compared between groups.
Measured: Baseline; daily from Day 1 to Day 10; and at Week 4 post-randomisation
Change in quality of life (EQ-5D)
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at baseline and Week 4 post-randomisation. The EQ-5D-5L descriptive system evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each scored on a 5-point ordinal scale (1 = no problems, 5 = extreme problems).
Measured: Baseline and Week 4 post-randomisation
Change in quality of life (SF-12)
Quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12) at baseline and Week 4 post-randomisation. The SF-12 is a validated instrument designed to evaluate health-related quality of life across physical and mental health domains. It yields two composite summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Each component score typically ranges from 0 to 100, with higher scores indicating better health status.
Measured: Baseline and Week 4 post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start9 Oct 2025
- Primary completion20 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcers (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Ansteel Group General Hospital
- Responsible party
- Principal investigator, Lin Tao, Shenyang Medical College
- Investigators
- Yun-En Liu, MD, Study chair, Shenyang Medical CollegeLin Tao, MM, Principal investigator, Shenyang Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198061
- Sponsor's protocol ID
- CAP_Foot_Ulcers
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07198061
- Acronym / sponsor ID
- CAP_Foot_Ulcers
- Keywords
- Cold Atmospheric Plasma, Diabetic Foot Ulcers, lower extremity arterial occlusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shenyang Medical CollegeUniversity, hospital or other
- Collaborators
- Ansteel Group General Hospital
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does CAP treatment lead to a greater reduction in ulcer area by Week 4 compared to placebo?;
- 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:
- Receive either active CAP therapy or sham CAP therapy once daily for 10 days following endovascular revascularisation
- Undergo daily wound assessments for ulcer area, signs of infection, and pain scores
- Complete quality-of-life questionnaires (EQ-5D and SF-12) at baseline and Week 4
- Be followed through Week 4 to assess efficacy and safety endpoints
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cold Atmospheric Plasma (CAP) Group | Experimental | Device: Cold Atmospheric Plasma (CAP), Procedure: Infrapopliteal Endovascular Revascularisation, Other: Guideline-Based Standard DFU CareParticipants with diabetic foot ulcers (DFUs) and infrapopliteal arterial occlusion who receive CAP therapy once daily for 10 days following successful endovascular intervention. |
| Sham CAP (Placebo) Group | Placebo comparator | Device: Sham CAP Therapy, Procedure: Infrapopliteal Endovascular Revascularisation, Other: Guideline-Based Standard DFU CareParticipants with DFUs and infrapopliteal arterial occlusion who receive sham CAP therapy with an identical-looking device that does not produce active plasma. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Cold Atmospheric Plasma (CAP) Group |
| Sham CAP TherapyIdentical equipment without plasma activation; simulates treatment environment (sound, airflow) for participant blinding. | Device | Sham CAP (Placebo) Group |
| Infrapopliteal Endovascular RevascularisationBalloon 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. | Procedure or surgery | Cold Atmospheric Plasma (CAP) Group, Sham CAP (Placebo) Group |
| Guideline-Based Standard DFU CareAll participants will receive diabetic foot ulcer (DFU) care according to current international and Chinese clinical guidelines | Other | Cold Atmospheric Plasma (CAP) Group, Sham CAP (Placebo) Group |
Primary outcome
Change in ulcer area (cm²)
Time frame: 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.
4 secondary outcomes
Time to 10% reduction in ulcer area
Time frame: From baseline through Day 10 and Week 4 post-randomisation
Mean change in pain score measured by Visual Analogue Scale (VAS)
Time frame: Baseline; daily from Day 1 to Day 10; and at Week 4 post-randomisation
Change in quality of life (EQ-5D)
Time frame: Baseline and Week 4 post-randomisation
Change in quality of life (SF-12)
Time frame: Baseline and Week 4 post-randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yun-En Liu, MD study chair
Shenyang Medical College
Lin Tao, MM principal investigator
Shenyang Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Atmospheric Plasma (CAP), Infrapopliteal Endovascular Revascularisation and Guideline-Based Standard DFU Care in people with Diabetic Foot Ulcers (DFU) and Lower Extremity Arterial Occlusion, run by Shenyang Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun-En Liu, MD (86-24-62215130, lye9901@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ulcer area (cm²) (time frame: assessed at baseline, Day 1 to Day 10 post-randomisation, and at Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.