Diabetic Foot UlcerCOSMASNCT07251426
Cold atmOspheric plaSMa Therapy Versus standArd Wound Care in Diabetic Foot and Venous Leg ulcerS
A study testing COLD ATMOSPHERIC PLASMA in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Olaf Bakker.
Trial summary
Chronic wounds such as diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) pose a major health burden to the patients but also to the healthcare system because of their distorted healing capacity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Venous Leg Ulcer
- What is being tested?
- COLD ATMOSPHERIC PLASMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to 30 Nov 2028
- 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
- 1. is referred to one of the participating hospitals for treatment of a diabetic foot ulcer (DFU) or venous leg ulcer (VLU) with healing stagnation and
- For VLU: i. An ulcer on the lower leg resulting from malfunctioning venous valves in the leg veins.
- For DFU: i. An ulcer on the foot or lower leg in person with currently or previously diagnosed diabetes mellitus and usually accompanied by neuropathy and/or peripheral artery disease (PAD) in the lower extremity Note: In patients with both diabetes and chronic venous insufficiency, ulcers will be categorized as DFU in case of symptoms of diabetic neuropathy or loss of protective sensation, and otherwise categorized as VLU.
- 2. has a wound with a minimum wound surface area of 0.5 cm2 and a maximum diameter of 6 cm (~28 cm2 wound surface area for circular wounds; measured after debridement),
- 3. has a minimum age of 18 years old.
Who cannot join
- 1. the participant has one or more of the following contraindications for PLASOMA:
- extreme exudative wounds, i.e. wounds in which moisture is visible within seconds after patting dry;
- any implanted active electronic device, such as a pacemaker, is present;
- an electronic medical device attached to the body, for example electronic life support equipment, a hearing aid, insulin pump or dialysis machine. If this medical device can be disconnected, PLASOMA treatment may be performed. If the sole purpose of this medical device is monitoring, such as a glucose sensor, PLASOMA treatment is not contra-indicated but note that use of PLASOMA together with such devices has not been tested and may lead to erroneous operation of the attached device during PLASOMA treatment;
- metal in the area 10 cm around pad-electrode area, e.g. metal sutures and implants;
- connection from outside the body to (near) the heart is present, e.g. a central venous catheter;
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- the participant has epilepsy;
- the participant is pregnant.
- 2. the participant has more than one wound that requires professional wound care.
- 3. for DFU the WIfI-classification is wound grade 3, defined as an extensive, deep ulcer involving forefoot and/or midfoot; deep, full thickness heel ulcer + calcaneal involvement.
- 4. presence of ischemia grade 2 or 3, according to the WIfI classification (= the ankle-brachial pressure index (ABI) is ≤0.59 OR the ankle systolic pressure is ≤69 mmHg OR the toe pressure is ≤39 mmHg; there should be at least one of these three measurements available).
- 5. a deep infection defined as an infection of the wound involving structures deeper than skin and subcutaneous tissues (e.g., abscess, osteomyelitis, septic arthritis, fasciitis).
- 6. the wound is located on a toe.
- 7. the participant receives treatment with immunosuppressive agents or oral corticosteroids; no exclusion if participant has received a stable dose for at least 2 months and the oral corticosteroid dose does not exceed 7.5 mg/day prednisone or equivalent.
- 8. the participant is receiving or likely to receive offloading with a total contact cast or advanced wound therapies - such as negative pressure therapy, hyperbaric oxygen therapy, biologicals (e.g. skin substitutes, growth factors), electrophysical therapy - for the to be-treated wound. Advanced wound dressings (including but not limited to hydrocolloid, hydrogel, alginate, collagen and antimicrobial dressings) are not excluded.
- 9. presence of a chronic or active skin disorder that may negatively influence wound healing (such as Marfan or Ehlers-Danlos syndrome).
- 10. the participant takes part in another study that is likely to compromise the outcome of this study or the feasibility of the participant fulfilling this study.
- 11. the participant is lactating.
- 12. the participant is unable to provide consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cold atmOspheric plaSMa Therapy Versus standArd Wound Care in Diabetic Foot and Venous Leg ulcerS - a Randomized Controlled Trial
Chronic wounds such as diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) pose a major health burden to the patients but also to the healthcare system because of their distorted healing capacity. This is mainly due to a prolonged treatment duration, high recurrence rates and substantial healthcare costs in wound care. Current guidelines exist that outline the standard wound care (SWC) in these patient groups but it often fails to achieve timely healing. Cold atmospheric plasma (CAP) is an emerging technology with promising antimicrobial and wound healing properties. In vitro and in vivo studies have highlighted the ability of CAP to reduce the bacterial biofilm load and stimulate tissue regeneration and microcirculation. This Randomized Controlled Trial (RCT) aims to evaluate the clinical effectiveness and cost-effectiveness of CAP in addition to SWC in patients with a DFU and VLU.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer
- Being tested
- COLD ATMOSPHERIC PLASMA
- Medical subject headings
- Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLD ATMOSPHERIC PLASMADevice
Cold Atmospheric plasma treatment in addition to standard wound care
| Study group | Role | What they receive |
|---|---|---|
| Cold atmospheric Plasma | Experimental | Cold Atmospheric Plasma Treatment 2x per week Receives: Device: COLD ATMOSPHERIC PLASMA |
| Standard Wound Care | No intervention | The use of standardized wound care 2x per week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer-free survival days
number of days within the follow-up period (until 26 weeks after the start of the treatment) where the participant is alive and has no ulcer on the same anatomical location of the same foot or limb
Measured: 26 weeks
Secondary outcomes (13)
Quality of Life (QoL)
The quality of life will be determined using the questionnaires EQ-5D-5L (generic). EQ-5D-5L descriptive system is divided into five levels of perceived problems: mobility, self-care, usual activities, pain/discomfort, anxiety/depression.
LEVEL 1: no problem LEVEL 2: slight problems LEVEL 3: moderate problems LEVEL 4: severe problems LEVEL 5: unable to/extreme problems Best outcome is therefore a score of 1 in all categories (total score=5), and worst outcome is a score of 5 in all categories (total score=25).
Measured: baseline, 13 weeks and 26 weeks
Wound Quality of Life (Wound-QoL)
The wound-QoL (wound-specific Quality of Life) will also be measured since complex wounds have a major impact on patients' well-being. The questionnaire is made of three subscales, body, psyche and everyday life. Answers to each item are coded with numbers (0='not at all' to 4='very much'). Minimal score is therefore 0 (no impairement) and maximal 17 (maximum impairement). The higher the outcome the worst the quality of life.
Measured: baseline, 13 weeks, 26 weeks
Wound healing rate
is defined as the percentage of wounds that are healed
Measured: 26 weeks
time to wound healing
defined as the period measured in days between the start of the treatment period and confirmed wound healing as defined under primary endpoint
Measured: 26 weeks
Surface area reduction
defined as the percentage of wound area reduction, measured using the eKare insight app, which automatically measures the wound metrics. Surface area reduction can show the added value for wounds that are not healed
Measured: 26 weeks
Recurrences
presence of an ulcer at the same anatomical location of the same foot or limb of the initially treated ulcer
Measured: 26 weeks
Development of new ulcers
defined as a new break in the skin not classified as a recurrence, thus not on the same location as the initially treated ulcer
Measured: 26 weeks
Wound pain
Chronic wound pain level is evaluated using question 1 of the Wound-QoL (quality of life) questionnaire to identify any reduction in wound pain. Answers are coded with numbers (0='not at all' to 4='very much'). Minimal score is therefore 0 (no impairement) and maximal 4 (maximum impairement). The higher the outcome the worst the pain level.
Measured: 26 weeks
Wound infection
the percentage wound infections is another measure of treatment efficacy, as CAP is bactericidal, and may indicate potential for reduction in use of antibiotics
Measured: 26 weeks
Occurence of adverse events
will be recorded according to article 80 of the Medical Device Regulation
Measured: 26 weeks
presence of amputations
presence of amputations on the same limb as the treated ulcer, occurring during the treatment or follow-up period (classified as yes/no).
Measured: 26 weeks
Cost of Care
the total healthcare costs related to the treatment of the ulcer during the treatment and follow-up period, including the costs of wound care materials, healthcare professional time, hospital visits, interventions and other medical resource use
Measured: 26 weeks
Cost Effectiveness
the cost per unit of clinical benefit evaluated by comparing the total costs between the intervention and control group in relation to the primary outcome
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Masking
- None (open label)
- Enrolment
- 494 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olaf Bakker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olaf Bakker, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251426
- Sponsor's protocol ID
- NL009805
- Other IDs
- NL009805
- Acronym
- COSMAS
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold atmOspheric plaSMa Therapy Versus standArd Wound Care in Diabetic Foot and Venous Leg ulcerS - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07251426
- Acronym / sponsor ID
- COSMAS / NL009805
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 494 participants (estimated)
- Lead sponsor
- Olaf BakkerUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 26 Nov 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.
Chronic wounds such as diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) pose a major health burden to the patients but also to the healthcare system because of their distorted healing capacity. This is mainly due to a prolonged treatment duration, high recurrence rates and substantial healthcare costs in wound care. Current guidelines exist that outline the standard wound care (SWC) in these patient groups but it often fails to achieve timely healing. Cold atmospheric plasma (CAP) is an emerging technology with promising antimicrobial and wound healing properties. In vitro and in vivo studies have highlighted the ability of CAP to reduce the bacterial biofilm load and stimulate tissue regeneration and microcirculation. This Randomized Controlled Trial (RCT) aims to evaluate the clinical effectiveness and cost-effectiveness of CAP in addition to SWC in patients with a DFU and VLU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold atmospheric Plasma | Experimental | Device: COLD ATMOSPHERIC PLASMACold Atmospheric Plasma Treatment 2x per week |
| Standard Wound Care | No intervention | –The use of standardized wound care 2x per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. is referred to one of the participating hospitals for treatment of a diabetic foot ulcer (DFU) or venous leg ulcer (VLU) with healing stagnation and
- 2. has a wound with a minimum wound surface area of 0.5 cm2 and a maximum diameter of 6 cm (~28 cm2 wound surface area for circular wounds; measured after debridement),
- 3. has a minimum age of 18 years old.
Key exclusion criteria (19 listed)
- 1. the participant has one or more of the following contraindications for PLASOMA:
- 2. the participant has more than one wound that requires professional wound care.
- 3. for DFU the WIfI-classification is wound grade 3, defined as an extensive, deep ulcer involving forefoot and/or midfoot; deep, full thickness heel ulcer + calcaneal involvement.
- 4. presence of ischemia grade 2 or 3, according to the WIfI classification (= the ankle-brachial pressure index (ABI) is ≤0.59 OR the ankle systolic pressure is ≤69 mmHg OR the toe pressure is ≤39 mmHg; there should be at least one of these three measurements available).
- 5. a deep infection defined as an infection of the wound involving structures deeper than skin and subcutaneous tissues (e.g., abscess, osteomyelitis, septic arthritis, fasciitis).
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 PLASMACold Atmospheric plasma treatment in addition to standard wound care | Device | Cold atmospheric Plasma |
Primary outcome
Ulcer-free survival days
Time frame: 26 weeks
number of days within the follow-up period (until 26 weeks after the start of the treatment) where the participant is alive and has no ulcer on the same anatomical location of the same foot or limb
13 secondary outcomes
Quality of Life (QoL)
Time frame: baseline, 13 weeks and 26 weeks
Wound Quality of Life (Wound-QoL)
Time frame: baseline, 13 weeks, 26 weeks
Wound healing rate
Time frame: 26 weeks
time to wound healing
Time frame: 26 weeks
Surface area reduction
Time frame: 26 weeks
Recurrences
Time frame: 26 weeks
Development of new ulcers
Time frame: 26 weeks
Wound pain
Time frame: 26 weeks
Wound infection
Time frame: 26 weeks
Occurence of adverse events
Time frame: 26 weeks
presence of amputations
Time frame: 26 weeks
Cost of Care
Time frame: 26 weeks
Cost Effectiveness
Time frame: 26 weeks
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 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Better Care Closer to Home: Enhancing Primary and Community Care
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EDX110 Randomized Control Trial for Treatment of DFUs
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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.
Questions about this trial
What is this clinical trial studying?
A study testing COLD ATMOSPHERIC PLASMA in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Olaf Bakker.
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 5 inclusion and 19 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 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Mikaella Loizou (+31639137130, m.loizou@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer-free survival days (time frame: 26 weeks). 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 26 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.