Peripheral Occlusive DiseasePICPADNCT07571408
Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complications in the Inguinal Region of High-risk Patients With Peripheral Arterial Occlusive Disease
A study testing Cold atmospheric plasma in people with Peripheral Occlusive Disease and Wound Healing, run by Ursula Werra at 1 site in Germany.
Trial summary
The goal of this clinical trial is to learn if postoperative wound complications in the inguinal region of high-risk patients with peripheral arterial occlusive disease can be prevented by the intraoperative application of cold atmospheric plasma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Occlusive Disease, Wound Healing, Wound Healing Complication
- What is being tested?
- Cold atmospheric plasma
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2026to 1 Jun 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Written informed consent
- Surgical treatment of peripheral arterial occlusive disease (PAOD) with femoral (inguinal) access
- High-risk patient for wound healing complications:
- WHD (wound healing disorder) score ≥ 4 points:
- Diabetes mellitus (2) Immunosuppression/steroid therapy (2) End-stage renal disease (2) Reinterventions (2) Peripheral arterial occlusive disease (1) Nicotine abuse (1) Obesity (BMI > 30) (1) Age > 80 years (1) Duration of surgery > 4 h (1) Blood loss > 1.5 L (1) Local radiotherapy/chemotherapy (1)
Who cannot join
- Pregnancy or breastfeeding
- Femoral access for an indication other than PAOD
- Preoperative local infection or infectious skin disease
- Life expectancy < 3 months
- Active infection of the ipsilateral extremity requiring systemic antibiotic therapy at the time of surgery
- Systemic antibiotic therapy at the time of surgery
Show all 9Show fewer
- Use of coated incisional drapes (e.g., iodine-impregnated)
- Intraoperative use of anti-infective topical agents (e.g., Gentacoll, doxycycline, etc.)
- Use of fibrin sealants/thrombogenic adhesive substances above the fascia Planned postoperative prophylactic negative pressure wound therapy (NPWT)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Department of Vascular and Endovascular Surgery
Cologne, North Rhine-Westphalia, 50937
About this study
Official title: Prophylactic Application of Cold Atmospheric Plasma to Reduce Postoperative Wound Healing Disorders in the Inguinal Region in High-risk Patients With Peripheral Arterial Occlusive Disease- Intraoperative Application of Cold Atmospheric Plasma in the Inguinal Region
The goal of this clinical trial is to learn if postoperative wound complications in the inguinal region of high-risk patients with peripheral arterial occlusive disease can be prevented by the intraoperative application of cold atmospheric plasma.
The main questions it aims to answer are:
Read more
Does the intraoperative application of cold atmospheric plasma reduce the need for surgical revision of inguinal wounds due to wound healing complications within 3 months postoperatively? Does the intraoperative application of cold atmospheric plasma reduce wound healing complications not requiring revision within 3 months postoperatively?
Researchers will compare the application of cold atmospheric plasma to a placebo (a deactivated look-alike device).
Participants will:
Undergo surgical treatment with femoral artery access due to their peripheral arterial occlusive disease, in accordance with the respective vascular surgery department standard of care.
Receive a single application of cold atmospheric plasma or, respectively, placebo in the area of their inguinal access wound during surgery (after subcutaneous closure and prior to skin closure).
Be regularly assessed for wound healing during the first postoperative 14 days as part of routine clinical care and undergo a final evaluation at 3 months. They will also be surveyed regarding their quality of life.
- Conditions
- Peripheral Occlusive Disease, Wound Healing, Wound Healing Complication, Cold Atmospheric Plasma, Prevention
- Being tested
- Cold atmospheric plasma, Sham device
- Keywords
- cold atmospheric plasma, prevention, wound healing disorder, vascular surgery, peripheral occlusive disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold atmospheric plasmaDevice
Single intraoperative treatment of the wound edges and the subcutaneous tissue adjacent to the wound edges with cold atmospheric plasma after subcutaneous closure and prior to skin closure
Sham deviceDevice
Single intraoperative treatment of the wound edges and the subcutaneous tissue adjacent to the wound edges with sham device after subcutaneous closure and prior to skin closure
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Intraoperative application of cold atmospheric plasma | Active comparator | During surgery (after subcutaneous closure and prior to skin closure), patients receive a single application of cold atmospheric plasma in the area of their inguinal access wound. Receives: Device: Cold atmospheric plasma |
| Control: Intraoperative sham application mimicking cold atmospheric plasma | Sham comparator | During surgery (after subcutaneous closure and prior to skin closure), patients receive a sham application mimicking cold atmospheric plasma in the area of the inguinal access wound. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to revision surgery due to inguinal wound healing complications
Measured: within 3 months postoperatively
Secondary outcomes (18)
Number of wound healing complications not requiring surgical revision
Measured: within 3 months postoperatively
Time to MACE (major adverse cardiac events) (myocardial infarction, cardiovascular death, stroke)
Measured: within 3 months postoperatively
Time to MALE (major adverse limb events) (amputation, graft occlusion, unplanned repeat revascularization)
Measured: within 3 months postoperatively
course of patients quality of life over the course of wound healing
Patients will be provided with the EQ-5D-5L (European Quality of Life 5 Dimensions 5 Level Version) questionnaire in order to assess quality of life at the baseline visit as well as follow-up visits 3 and 4 and after 3 months (end of study visit).
The EQ-5D-5L will be evaluated by converting responses across its five domains-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-into a single health utility index using a country-specific value set (e.g., German tariff), with possible values typically ranging from below 0 (worse than death) to 1 (full health). Each domain is rated on a 5-level scale, where 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, and 5 = extreme problems/unable to perform. In addition, the EQ Visual Analogue Scale (EQ VAS) score will be analyzed separately, ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: within 3 months postoperatively
course of estimated Glomerular Filtration Rate (eGFR) over the course of wound healing
According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: eGFR ml/min/1.73m²
Measured: within 3 months postoperatively
course of white blood cell count over the course of wound healing
According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: white blood cell count 10*9/L
Measured: within 3 months postoperatively
course of C- reaktive protein over the course of wound healing
According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: C- reaktive protein (mg/L)
Measured: within 3 months postoperatively
course of procalcitonin over the course of wound healing
According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: procalcitonin (ng/ml)
Measured: within 3 months postoperatively
course of hemoglobin over the course of wound healing
According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: hemoglobin g/dl
Measured: within 3 months postoperatively
course of platelets over the course of wound healing
According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: platelets 10*9/L
Measured: within 3 months postoperatively
Course of haematocrit over the course of wound healing
According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: haematocrit (%)
Measured: within 3 months postoperatively
course of albumin over the course of wound healing
According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: albumin (g/L)
Measured: within 3 months postoperatively
course of sodium over the course of wound healing
According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: sodium mmol/L
Measured: within 3 months postoperatively
course of potassium over the course of wound healing
According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: potassium (mmol/L)
Measured: within 3 months postoperatively
course of International Normalized Ratio (INR) over the course of wound healing
According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: INR
Measured: within 3 months postoperatively
course of partial thromboplastin time over the course of wound healing
According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case:partial thromboplastin time (s)
Measured: within 3 months postoperatively
course of total cholersterol over the course of wound healing
According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: total cholesterol (mg/dl)
Measured: within 3 months postoperatively
course of low- density- lipoprotein cholesterol (LDL cholesterol) over the course of wound healing
According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: LDL cholesterol
Measured: within 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Occlusive DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ursula Werra
- Sponsor type
- University, hospital or other
- Collaborators
- neoplas med GmbH, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor-investigator, Ursula Werra, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571408
- Sponsor's protocol ID
- PICPAD-2026-01
- Acronym
- PICPAD
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available. Data will be used solely for the purposes of this study and will be processed in accordance with applicable data protection regulations (GDPR). Statistical analysis will be performed by an independent academic biostatistics institute (Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf).
Publications
Werra UEM, Ahmad W, Schoepal M, Trinh TT, Dorweiler B. Intraoperative Application of Cold Atmospheric Plasma Reduces Inguinal Wound Healing Disorders-A Pilot Study. J Clin Med. 2025 Oct 24;14(21):7533. doi: 10.3390/jcm14217533.
PubMed 41226930
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Application of Cold Atmospheric Plasma to Reduce Postoperative Wound Healing Disorders in the Inguinal Region in High-risk Patients With Peripheral Arterial Occlusive Disease- Intraoperative Application of Cold Atmospheric Plasma in the Inguinal Region
- ClinicalTrials.gov ID
- NCT07571408
- Acronym / sponsor ID
- PICPAD / PICPAD-2026-01
- Conditions
- Peripheral Occlusive Disease, Wound Healing, Wound Healing Complication, Cold Atmospheric Plasma, Prevention
- Keywords
- cold atmospheric plasma, prevention, wound healing disorder, vascular surgery, peripheral occlusive disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Ursula WerraUniversity, hospital or other
- Collaborators
- neoplas med GmbH, Universitätsklinikum Hamburg-Eppendorf
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 6 May 2026 (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 learn if postoperative wound complications in the inguinal region of high-risk patients with peripheral arterial occlusive disease can be prevented by the intraoperative application of cold atmospheric plasma.
The main questions it aims to answer are:
Does the intraoperative application of cold atmospheric plasma reduce the need for surgical revision of inguinal wounds due to wound healing complications within 3 months postoperatively? Does the intraoperative application of cold atmospheric plasma reduce wound healing complications not requiring revision within 3 months postoperatively?
Researchers will compare the application of cold atmospheric plasma to a placebo (a deactivated look-alike device).
Participants will:
Undergo surgical treatment with femoral artery access due to their peripheral arterial occlusive disease, in accordance with the respective vascular surgery department standard of care.
Receive a single application of cold atmospheric plasma or, respectively, placebo in the area of their inguinal access wound during surgery (after subcutaneous closure and prior to skin closure).
Be regularly assessed for wound healing during the first postoperative 14 days as part of routine clinical care and undergo a final evaluation at 3 months. They will also be surveyed regarding their quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Intraoperative application of cold atmospheric plasma | Active comparator | Device: Cold atmospheric plasmaDuring surgery (after subcutaneous closure and prior to skin closure), patients receive a single application of cold atmospheric plasma in the area of their inguinal access wound. |
| Control: Intraoperative sham application mimicking cold atmospheric plasma | Sham comparator | Device: Sham deviceDuring surgery (after subcutaneous closure and prior to skin closure), patients receive a sham application mimicking cold atmospheric plasma in the area of the inguinal access wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- Written informed consent
- Surgical treatment of peripheral arterial occlusive disease (PAOD) with femoral (inguinal) access
- High-risk patient for wound healing complications:
- Diabetes mellitus (2) Immunosuppression/steroid therapy (2) End-stage renal disease (2) Reinterventions (2) Peripheral arterial occlusive disease (1) Nicotine abuse (1) Obesity (BMI > 30) (1) Age > 80 years (1) Duration of surgery > 4 h (1) Blood loss > 1.5 L (1) Local radiotherapy/chemotherapy (1)
Key exclusion criteria (9 listed)
- Pregnancy or breastfeeding
- Femoral access for an indication other than PAOD
- Preoperative local infection or infectious skin disease
- Life expectancy < 3 months
- Active infection of the ipsilateral extremity requiring systemic antibiotic therapy at the time of surgery
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 plasmaSingle intraoperative treatment of the wound edges and the subcutaneous tissue adjacent to the wound edges with cold atmospheric plasma after subcutaneous closure and prior to skin closure | Device | Intervention: Intraoperative application of cold atmospheric plasma |
| Sham deviceSingle intraoperative treatment of the wound edges and the subcutaneous tissue adjacent to the wound edges with sham device after subcutaneous closure and prior to skin closure | Device | Control: Intraoperative sham application mimicking cold atmospheric plasma |
Primary outcome
Time to revision surgery due to inguinal wound healing complications
Time frame: within 3 months postoperatively
18 secondary outcomes
Number of wound healing complications not requiring surgical revision
Time frame: within 3 months postoperatively
Time to MACE (major adverse cardiac events) (myocardial infarction, cardiovascular death, stroke)
Time frame: within 3 months postoperatively
Time to MALE (major adverse limb events) (amputation, graft occlusion, unplanned repeat revascularization)
Time frame: within 3 months postoperatively
course of patients quality of life over the course of wound healing
Time frame: within 3 months postoperatively
course of estimated Glomerular Filtration Rate (eGFR) over the course of wound healing
Time frame: within 3 months postoperatively
course of white blood cell count over the course of wound healing
Time frame: within 3 months postoperatively
course of C- reaktive protein over the course of wound healing
Time frame: within 3 months postoperatively
course of procalcitonin over the course of wound healing
Time frame: within 3 months postoperatively
course of hemoglobin over the course of wound healing
Time frame: within 3 months postoperatively
course of platelets over the course of wound healing
Time frame: within 3 months postoperatively
Course of haematocrit over the course of wound healing
Time frame: within 3 months postoperatively
course of albumin over the course of wound healing
Time frame: within 3 months postoperatively
course of sodium over the course of wound healing
Time frame: within 3 months postoperatively
course of potassium over the course of wound healing
Time frame: within 3 months postoperatively
course of International Normalized Ratio (INR) over the course of wound healing
Time frame: within 3 months postoperatively
course of partial thromboplastin time over the course of wound healing
Time frame: within 3 months postoperatively
course of total cholersterol over the course of wound healing
Time frame: within 3 months postoperatively
course of low- density- lipoprotein cholesterol (LDL cholesterol) over the course of wound healing
Time frame: within 3 months postoperatively
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 6 May 2026.
- Background: PubMed 41226930Werra UEM, Ahmad W, Schoepal M, Trinh TT, Dorweiler B. Intraoperative Application of Cold Atmospheric Plasma Reduces Inguinal Wound Healing Disorders-A Pilot Study. J Clin Med. 2025 Oct 24;14(21):7533. doi: 10.3390/jcm14217533.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. Data will be used solely for the purposes of this study and will be processed in accordance with applicable data protection regulations (GDPR). Statistical analysis will be performed by an independent academic biostatistics institute (Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf).
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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.
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 in people with Peripheral Occlusive Disease and Wound Healing, run by Ursula Werra at 1 site in Germany.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 6 May 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 Germany. 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 Ursula EM Werra, MD (0049+22147830757, ursula.werra@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to revision surgery due to inguinal wound healing complications (time frame: within 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07571408, which also lists 1 linked publication.
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 6 May 2026.