Venous Leg UlcerNCT04922463
PLASOMA Efficacy & Technology Health (PETH) Study
A study testing PLASOMA in people with Venous Leg Ulcer, run by Plasmacure at 2 sites in Netherlands.
Trial summary
This study is designed to examine beneficial effects of PLASOMA treatment compared to the standard of care on chronic venous leg ulcers (VLU) that match the size of the plasma area of the pad. The intention is that the data obtained with this study will be used to: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg 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
- 46 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jun 2021to 20 Apr 2023
- 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 lower leg ulcer presumed to be caused by venous insufficiency (VLU). The wound should have insufficient healing (<30% surface area reduction) during the last 2 weeks of standard wound care.
- INCL2: have 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).
- INCL3: have an Ankle Brachial Pressure Index (ABPI) between 0.8 and 1.3. Note 1: subject can be included based on a VLU diagnosis from anamnesis. Make sure an ABPI measurement is performed as soon as possible to verify the diagnosis. The subject has to be excluded if the ABPI is not between 0.8 and 1.3.
- Note 2: For diabetic patients an ABPI measurement is not always reliable. Therefore, diabetic patients can be included based on a VLU diagnosis from anamnesis, but no ABPI measurement needs to be performed.
- INCL4: have a minimum age of 18 years old.
- INCL5: For home care treatments only: there is 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 16Show 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
- EXCL2: the subject uses systemic antibiotics.
- EXCL3: the subject has any known malignant wound degeneration.
- EXCL4: 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.
- EXCL5: the subject is receiving or likely to receive advanced wound dressings or advanced therapies- such as negative pressure therapy, hyperbaric oxygen therapy, biologicals (e.g. skin substitutes, growth factors), electrophysical therapy - for the to-be-treated wound.
- EXCL6: the subject cannot (agree to) comply with the SOC.
- EXCL7: the subject participates in another study which is likely to compromise the outcome of the PETH study or the feasibility of thesubject fulfilling the PETH study.
- EXCL8: the subject is unable to provide consent.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
BBeterzorg
Sittard, 6135KD
Thebe Zorg Thuis
Tilburg, 5042 DA
About this study
Official title: PLASOMA Efficacy & Technology Health (PETH) Study: A Post-market Randomised Controlled Efficacy Study of PLASOMA on Wound Healing in Chronic Venous Leg Ulcers
This study is designed to examine beneficial effects of PLASOMA treatment compared to the standard of care on chronic venous leg ulcers (VLU) that match the size of the plasma area of the pad.
The intention is that the data obtained with this study will be used to:
- Demonstrate comparative performance of PLASOMA (for two treatment frequencies)
- Provide evidence for health technology assessments (HTA) of PLASOMA
Read the detailed description
The PETH study will be an open label three-armed randomized controlled trial (RCT) on chronic VLU. The study will be performed at one study site in the Netherlands.
The three arms are:
- Control group: standard care for 12 weeks or until healing, whichever occurs first;
- Treatment group-1: standard care + PLASOMA treatment once per week for 12 weeks or until healing, whichever occurs first;
- Treatment group-2: standard care + PLASOMA treatment twice per week for 12 weeks or until healing, whichever occurs first.
After the treatment period there will be two follow up timepoints: 2 weeks after the end of the treatment period (FU1) and 12 weeks after the end of the treatment period (FU2).
Subjects will be allocated to one of the three arms according to a pre-defined randomization schedule.
Primary study parameters/outcome of the study:
Evaluate the percentage of wounds healed after 12 weeks of treatment with PLASOMA for two treatment frequencies: once per week and twice per week.
This will be done by comparing the treatment groups with the control group
- Conditions
- Venous Leg Ulcer
- Being tested
- PLASOMA
- Medical subject headings
- Varicose Ulcer
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 | Not described |
| 1x PLASOMA | Experimental | Not described Receives: Device: PLASOMA |
| 2x PLASOMA | Experimental | Not described Receives: Device: PLASOMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the percentage of wounds healed after 12 weeks of treatment with PLASOMA for two treatment frequencies: once per week and twice per week
Measured: 12 weeks
Secondary outcomes (19)
Wound healing
Measured: 4 weeks
Time to healing
Measured: until 12 weeks
% Wounds with wound surface area reduction ≥50%
Measured: 4 weeks
Wound surface area reduction
Measured: 4 weeks
Wound surface area reduction
Measured: 12 weeks
Wound volume reduction
Measured: 4 weeks
Wound volume reduction
Measured: 12 weeks
Number of recurrences
Measured: 5 weeks
Number of recurrences
Measured: 9 weeks
Number of recurrences
Measured: 12 weeks
Scarring
Measured: FU1 (2 weeks after end of treatment)
Scarring
Measured: FU2 (12 weeks after end of treatment)
Quality of life - general
RAND-36 questionnaire
Measured: FU1 (2 weeks after end of treatment)
Quality of life - wound specific
Wound-QOL questionnaire
Measured: FU1 (2 weeks after end of treatment)
Wound pain
wound pain, using 0-10 numerical rating scale
Measured: 20 weeks
Wound infection
wound infection (clinical classification)
Measured: until FU2 (12 weeks after end of treatment)
Health Technology Assessment
resources used
Measured: 20 weeks
Patient acceptability
subjects will be asked if they are happy with the PLASOMA treatment
Measured: 20 weeks
Adverse Events with a potential relation to PLASOMA
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jun 2021
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Why it stopped: The continuation of the study was rendered unreasonable due to the slow inclusion rate
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 Venous Leg 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plasmacure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Koen Lim, Study director, Plasmacure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922463
- Sponsor's protocol ID
- PETH study
- Status last verified
- Jun 2024
- First submitted
- 27 May 2021
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bakker O, Smits P, van Weersch C, Quaaden M, Bruls E, van Loon A, van der Kleij J. Improved Wound Healing by Direct Cold Atmospheric Plasma Once or Twice a Week: A Randomized Controlled Trial on Chronic Venous Leg Ulcers. Adv Wound Care (New Rochelle). 2025 Jan;14(1):1-13. doi: 10.1089/wound.2023.0196. Epub 2024 Jun 3.
PubMed 38687339
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLASOMA Efficacy & Technology Health (PETH) Study: A Post-market Randomised Controlled Efficacy Study of PLASOMA on Wound Healing in Chronic Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT04922463
- Acronym / sponsor ID
- PETH study
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The continuation of the study was rendered unreasonable due to the slow inclusion rate
- Enrolment
- 46 participants (actual)
- Lead sponsor
- PlasmacureIndustry (pharma, biotech, devices)
- Collaborators
- European Commission
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 10 Jun 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.
This study is designed to examine beneficial effects of PLASOMA treatment compared to the standard of care on chronic venous leg ulcers (VLU) that match the size of the plasma area of the pad.
The intention is that the data obtained with this study will be used to:
- Demonstrate comparative performance of PLASOMA (for two treatment frequencies)
- Provide evidence for health technology assessments (HTA) of PLASOMA
Detailed description
The PETH study will be an open label three-armed randomized controlled trial (RCT) on chronic VLU. The study will be performed at one study site in the Netherlands.
The three arms are:
- Control group: standard care for 12 weeks or until healing, whichever occurs first;
- Treatment group-1: standard care + PLASOMA treatment once per week for 12 weeks or until healing, whichever occurs first;
- Treatment group-2: standard care + PLASOMA treatment twice per week for 12 weeks or until healing, whichever occurs first.
After the treatment period there will be two follow up timepoints: 2 weeks after the end of the treatment period (FU1) and 12 weeks after the end of the treatment period (FU2).
Subjects will be allocated to one of the three arms according to a pre-defined randomization schedule.
Primary study parameters/outcome of the study:
Evaluate the percentage of wounds healed after 12 weeks of treatment with PLASOMA for two treatment frequencies: once per week and twice per week.
This will be done by comparing the treatment groups with the control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| 1x PLASOMA | Experimental | Device: PLASOMA |
| 2x PLASOMA | Experimental | Device: PLASOMA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- INCL1: have a slow-healing or non-healing lower leg ulcer presumed to be caused by venous insufficiency (VLU). The wound should have insufficient healing (<30% surface area reduction) during the last 2 weeks of standard wound care.
- INCL2: have 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).
- INCL3: have an Ankle Brachial Pressure Index (ABPI) between 0.8 and 1.3. Note 1: subject can be included based on a VLU diagnosis from anamnesis. Make sure an ABPI measurement is performed as soon as possible to verify the diagnosis. The subject has to be excluded if the ABPI is not between 0.8 and 1.3.
- Note 2: For diabetic patients an ABPI measurement is not always reliable. Therefore, diabetic patients can be included based on a VLU diagnosis from anamnesis, but no ABPI measurement needs to be performed.
- INCL4: have a minimum age of 18 years old.
Key exclusion criteria (16 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 | 1x PLASOMA, 2x PLASOMA |
Primary outcome
Evaluate the percentage of wounds healed after 12 weeks of treatment with PLASOMA for two treatment frequencies: once per week and twice per week
Time frame: 12 weeks
19 secondary outcomes
Wound healing
Time frame: 4 weeks
Time to healing
Time frame: until 12 weeks
% Wounds with wound surface area reduction ≥50%
Time frame: 4 weeks
Wound surface area reduction
Time frame: 4 weeks
Wound surface area reduction
Time frame: 12 weeks
Wound volume reduction
Time frame: 4 weeks
Wound volume reduction
Time frame: 12 weeks
Number of recurrences
Time frame: 5 weeks
Number of recurrences
Time frame: 9 weeks
Number of recurrences
Time frame: 12 weeks
Scarring
Time frame: FU1 (2 weeks after end of treatment)
Scarring
Time frame: FU2 (12 weeks after end of treatment)
Quality of life - general
Time frame: FU1 (2 weeks after end of treatment)
Quality of life - wound specific
Time frame: FU1 (2 weeks after end of treatment)
Wound pain
Time frame: 20 weeks
Wound infection
Time frame: until FU2 (12 weeks after end of treatment)
Health Technology Assessment
Time frame: 20 weeks
Patient acceptability
Time frame: 20 weeks
Adverse Events with a potential relation to PLASOMA
Time frame: 20 weeks
Results and safety
The study was stopped early (reason given: The continuation of the study was rendered unreasonable due to the slow inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Results publication: PubMed 38687339Bakker O, Smits P, van Weersch C, Quaaden M, Bruls E, van Loon A, van der Kleij J. Improved Wound Healing by Direct Cold Atmospheric Plasma Once or Twice a Week: A Randomized Controlled Trial on Chronic Venous Leg Ulcers. Adv Wound Care (New Rochelle). 2025 Jan;14(1):1-13. doi: 10.1089/wound.2023.0196. Epub 2024 Jun 3.
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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. This study is not recruiting at the moment.
Koen Lim study director
Plasmacure
2 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 Venous Leg Ulcer, run by Plasmacure at 2 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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: The continuation of the study was rendered unreasonable due to the slow inclusion rate). Results are not available in the source record.
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?
Evaluate the percentage of wounds healed after 12 weeks of treatment with PLASOMA for two treatment frequencies: once per week and twice per week (time frame: 12 weeks). 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 NCT04922463, 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 12 Jun 2024.