Diabetic Foot UlcerPULSENCT04828304
PLASOMA Ultimate Safety & Efficacy Study
A study testing PLASOMA in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Plasmacure at 6 sites in Netherlands.
Trial summary
The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: 1. Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. 2. Efficacy: To confirm the performance of PLASOMA, i.e. the beneficial effect on bacterial load. 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, Pressure Ulcer
- What is being tested?
- PLASOMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 6 sitesNetherlands
- Study dates
- 26 May 2021to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- INCL1: have a slow-healing or non-healing ulcer consisting of, but not limited to:
- diabetic ulcers (Wagner-Meggitt classification system/ University of Texas classification system: grades 1-3)
- venous ulcers
- pressure ulcers (international NPUAP/EPUAP classification system: categories/stages II-IV)
- burn wounds (second and third degree)
- skin grafts and flaps
Show all 11Show fewer
- infected post-surgical ulcers. Standard wound care has not resulted in sufficient healing after at least two weeks (including first line care) (Ref 25, Ref 26).
- Note: There is no upper limit for the duration that the wound exists. In case a subject has multiple wounds that meet the in- and exclusion criteria, the wound with the longest duration will be chosen for the study.
- INCL2: have a wound with a minimum wound surface area of 0.5 cm2 and a maximum diameter of 4.5 cm (~16 cm2 wound surface area for circular wounds).
- INCL3: have a minimum age of 18 years old.
- INCL4: for home care treatments only: have a grounded wall socket available for connection of PLASOMA.
Who cannot join
- EXCL1: the subject has one or more of the following contraindications for PLASOMA:
- the wound is very exudative, i.e. wounds in which moisture is visible again within a few minutes after patting dry.
- any implanted active electronic device, such as a pacemaker, is present.
- an electronic medical device is attached to the body, including electronic life support equipment, hearing aids, glucose sensors and insulin pumps. If the sole purpose of the medical device is monitoring, the subject is not excluded, but it should be noted 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.
- Note: no exclusion if electronic medical device will be detached during PLASOMA treatment.
- a metal implant (including a stent) is present in the treatment area, i.e. the area between pad and electrode.
Show all 15Show fewer
- a conductive connection from outside to inside the body at or near the heart is present, e.g. a catheter with electrolyte fluid.
- the subject has epilepsy
- the subject is pregnant
- the to-be-treated wound is located on the torso above the navel
- EXCL2: the subject has any known malignant wound degeneration.
- EXCL3: the subject receives treatment with immunosuppressive agents or oral corticosteroids; no exclusion if subject 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.
- EXCL4: the subject is receiving or likely to receive advanced wound therapies - such as negative pressure therapy, hyperbaric oxygen therapy, biologicals (e.g. skin substitutes, growth factors), electrophysical therapy - until FU1 for the to be-treated wound. Advanced wound dressings are not excluded.
- EXCL5: the subject participates in another study which is likely to compromise the outcome of the PULSE study or the feasibility of the subject fulfilling the PULSE study.
- EXCL6: the subject is unable to provide consent.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Groene Hart Ziekenhuis
Gouda
Alrijne Ziekenhuis
Leiderdorp
Sint Antonius Ziekenhuis
Nieuwegein
radboud Universitair Medisch Centrum
Nijmegen
Expertisecentrum Wondzorg (EcW)
Oosterhout
Maxima Medisch Centrum (MMC)
Veldhoven
About this study
The purpose of the PULSE study are the followingL
A.To perform post market clinical follow up (PMCF) on safety and efficacy:
Read more
- Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks.
- Efficacy: To confirm the performance of PLASOMA, i.e. the beneficial effect on bacterial load. B. Determine the effect of PLASOMA on wound surface area.
A secondary purpose is to examine the beneficial effects of PLASOMA on wound healing and to perform a health technology assessment (HTA).
This clinical study will be an open label two-armed randomized controlled trial (RCT), performed at at least three sites (multi-center) in the Netherlands.
The two arms are:
- Control group: Standard wound care for 12 weeks or until healing, whichever occurs first;
- Treatment group: Standard wound care + PLASOMA treatment for 12 weeks or until healing, whichever occurs first.
The frequency of PLASOMA treatment will be determined by the treating (para)medical professional based on the number of visits they would schedule for the standard wound care at the study site.
For all study subjects, the treatment frequency will be at least once per week (in order to have enough treatments for safety evaluation) and should not exceed once per day.
Follow up (FU) will be performed at three timepoints for both arms:
- FU1: 2 weeks after end treatment period
- FU2: 12 weeks after end treatment period
- FU3: 12 months after start treatment.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Burn Wound, Skin Graft, Infected Surgical Wound
- Being tested
- PLASOMA
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer, Burns, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLASOMADevice
Treatment with cold plasma device
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Standard of care |
| treatment group | Experimental | Standard of care + PLASOMA treatment Receives: Device: PLASOMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety PLASOMA - device related SAEs
device related SAEs
Measured: 12 months
Efficacy PLASOMA - bacterial load reduction - Staphylococcus aureus
Reduction in number of S. aureus colonies, using wound swab and quantitative analysis
Measured: once at week 1 (wound swab directly before and after first PLASOMA treatment)
Efficacy PLASOMA - wound surface area reduction
Wound surface area reduction
Measured: 12 weeks
Secondary outcomes (11)
Safety PLASOMA - all AEs
Safety reporting
Measured: 12 months
Safety PLASOMA - wound appearance
wound appearance
Measured: 24 weeks
Efficacy PLASOMA - Bacterial load reduction
Bacterial load reduction (total load and Pseudomonas aeruginosa), using wound swab and semi-quantitative analysis
Measured: once at week 1 (wound swab directly before and after first PLASOMA treatment)
Efficacy PLASOMA- wound healing
Wound healing - wound surface area reduction - wound volume reduction - time to healing
Measured: 12 weeks
Efficacy PLASOMA - Quality of Life
Quality of Life, using RAND-36 questionnaire
Measured: 14 weeks
Efficacy PLASOMA - Quality of Life
Quality of Life, using Wound-QoL questionnaire
Measured: 14 weeks
Efficacy PLASOMA - Ulcer recurrence
Ulcer recurrence
Measured: 12 months
Efficacy PLASOMA - wound infection
wound infection (clinical classification)
Measured: 12 weeks
Efficacy PLASOMA - wound pain
wound pain (0-10 numerical rating scale)
Measured: 12 weeks
Health Technology Assessment PLASOMA
resource usage PLASOMA
Measured: 12 weeks
Patient acceptability
Patient acceptability (subjects will be asked if they are happy with the PLASOMA treatment)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start26 May 2021
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plasmacure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Diabetes Fonds, Pathology and Medical Microbiology
- Responsible party
- Sponsor
- Investigators
- Koen Lim, Study director, Plasmacure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828304
- Sponsor's protocol ID
- PULSE study
- Acronym
- PULSE
- Status last verified
- May 2025
- First submitted
- 24 Mar 2021
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLASOMA Ultimate Safety & Efficacy Study
- ClinicalTrials.gov ID
- NCT04828304
- Acronym / sponsor ID
- PULSE / PULSE study
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Burn Wound, Skin Graft, Infected Surgical Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- PlasmacureIndustry (pharma, biotech, devices)
- Collaborators
- Diabetes Fonds, Pathology and Medical Microbiology
- Study start
- 26 May 2021 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 2 Apr 2021 (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 purpose of the PULSE study are the followingL
A.To perform post market clinical follow up (PMCF) on safety and efficacy:
- Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks.
- Efficacy: To confirm the performance of PLASOMA, i.e. the beneficial effect on bacterial load. B. Determine the effect of PLASOMA on wound surface area.
A secondary purpose is to examine the beneficial effects of PLASOMA on wound healing and to perform a health technology assessment (HTA).
This clinical study will be an open label two-armed randomized controlled trial (RCT), performed at at least three sites (multi-center) in the Netherlands.
The two arms are:
- Control group: Standard wound care for 12 weeks or until healing, whichever occurs first;
- Treatment group: Standard wound care + PLASOMA treatment for 12 weeks or until healing, whichever occurs first.
The frequency of PLASOMA treatment will be determined by the treating (para)medical professional based on the number of visits they would schedule for the standard wound care at the study site.
For all study subjects, the treatment frequency will be at least once per week (in order to have enough treatments for safety evaluation) and should not exceed once per day.
Follow up (FU) will be performed at three timepoints for both arms:
- FU1: 2 weeks after end treatment period
- FU2: 12 weeks after end treatment period
- FU3: 12 months after start treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Standard of care |
| treatment group | Experimental | Device: PLASOMAStandard of care + PLASOMA treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- diabetic ulcers (Wagner-Meggitt classification system/ University of Texas classification system: grades 1-3)
- venous ulcers
- pressure ulcers (international NPUAP/EPUAP classification system: categories/stages II-IV)
- burn wounds (second and third degree)
- skin grafts and flaps
Key exclusion criteria (15 listed)
- the wound is very exudative, i.e. wounds in which moisture is visible again within a few minutes after patting dry.
- any implanted active electronic device, such as a pacemaker, is present.
- an electronic medical device is attached to the body, including electronic life support equipment, hearing aids, glucose sensors and insulin pumps. If the sole purpose of the medical device is monitoring, the subject is not excluded, but it should be noted 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.
- Note: no exclusion if electronic medical device will be detached during PLASOMA treatment.
- a metal implant (including a stent) is present in the treatment area, i.e. the area between pad and electrode.
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 |
|---|---|---|
| PLASOMATreatment with cold plasma device | Device | treatment group |
Primary outcome
Safety PLASOMA - device related SAEs
Time frame: 12 months
device related SAEs
Efficacy PLASOMA - bacterial load reduction - Staphylococcus aureus
Time frame: once at week 1 (wound swab directly before and after first PLASOMA treatment)
Reduction in number of S. aureus colonies, using wound swab and quantitative analysis
Efficacy PLASOMA - wound surface area reduction
Time frame: 12 weeks
Wound surface area reduction
11 secondary outcomes
Safety PLASOMA - all AEs
Time frame: 12 months
Safety PLASOMA - wound appearance
Time frame: 24 weeks
Efficacy PLASOMA - Bacterial load reduction
Time frame: once at week 1 (wound swab directly before and after first PLASOMA treatment)
Efficacy PLASOMA- wound healing
Time frame: 12 weeks
Efficacy PLASOMA - Quality of Life
Time frame: 14 weeks
Efficacy PLASOMA - Quality of Life
Time frame: 14 weeks
Efficacy PLASOMA - Ulcer recurrence
Time frame: 12 months
Efficacy PLASOMA - wound infection
Time frame: 12 weeks
Efficacy PLASOMA - wound pain
Time frame: 12 weeks
Health Technology Assessment PLASOMA
Time frame: 12 weeks
Patient acceptability
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
Related trials for Diabetic Foot Ulcer
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
RecruitingObservational study
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
Diabetic Foot Ulcers (DFUs)
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
Not yet recruitingPhase 1
Placental Cells for Diabetic Foot Ulcers
Diabetic Foot Ulcer
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
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. This study is not recruiting at the moment.
Koen Lim study director
Plasmacure
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLASOMA in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Plasmacure at 6 sites in Netherlands.
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 11 inclusion and 15 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: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety PLASOMA - device related SAEs (time frame: 12 months). The study lists 3 primary outcomes in all. 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 3 Jun 2025.