An interventional study of Cold Atmospheric Plasma (CAP) and Sham CAP Therapy in Diabetic Foot Ulcers (DFU) and Lower Extremity Arterial Occlusion, sponsored by Shenyang Medical College. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Shenyang Medical College · Not applicable, Interventional, and Treatment
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:
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:
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Shenyang Medical College is the lead sponsor of 12 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Identical equipment without plasma activation; simulates treatment environment (sound, airflow) for participant blinding.
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.
All participants will receive diabetic foot ulcer (DFU) care according to current international and Chinese clinical guidelines
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.
Time frame: assessed at baseline, Day 1 to Day 10 post-randomisation, and at Week 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline and Week 4 post-randomisation
Incidence of skin irritation
The presence or absence of skin irritation at the treatment site will be recorded by trained clinical staff during each treatment session (Day 1-10) and at Week 4. Skin irritation includes erythema, rash, itching, or other subjective symptoms reported by the participant or observed by the investigator.
Time frame: Daily from baseline to Day 10 and at Week 4 post-randomisation
Incidence of local bleeding
Bleeding at the wound or treatment site will be assessed by visual inspection and clinical documentation. Events are recorded as present or absent at each time point, and severity (mild, moderate, severe) will be noted if applicable.
Time frame: Daily from baseline to Day 10 and at Week 4 post-randomisation
Incidence of local burning sensation
Participants will be asked to report any burning sensation at the treatment site during or after CAP exposure. Events will be recorded as present or absent, and graded based on severity. This outcome will help assess the tolerability of CAP treatment.
Time frame: Daily from baseline to Day 10 and at Week 4 post-randomisation
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Nov 2026, 13 months after the start.
Of 240 non-industry interventional studies with no phase under Diabetic Foot, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 13 months is below that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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Shenyang Medical College