Leg Ulcers VenousNCT03112395
Local Application of Combined Optical and Magnetic Stimulation (COMS) for Treatment of Chronic Wounds: Safety Evaluation
A study testing Pio Medical Device in people with Leg Ulcers Venous and Leg Ulcer Arterial, run by Piomic Medical AG at 3 sites in Switzerland.
Trial summary
The demographic shift and the increasing prevalence of chronic wounds represent major challenges for modern health care systems. Classic chronic wounds (venous ulcer, arterial ulcer, mixed ulcer) persist for months or years with a very slow or even no healing progress. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Leg Ulcers Venous, Leg Ulcer Arterial, Leg Ulcer Mixed
- What is being tested?
- Pio Medical Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 25 Apr 2017to 4 Jun 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Male and female patients
- Age: 18 - 90
- Chronic wound (venous ulcer, arterial ulcer, mixed ulcer) since at least 4 weeks
- Wound area minimal 1 cm2, maximal 50 cm2
- No adaptions for treatment of causal therapy of disease
Who cannot join
- Women who are pregnant
- Known or suspected non-compliance, drug or alcohol abuse,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons,
- Patients with active devices (e.g. Pacemakers and defibrillators, infusion devices, insulin pumps)
- Metallic implants and endoprosthesis at extremities lower than hip
- Life threatening condition
- Immunosuppressive after foreign organ transplant or chemotherapeutic treatment within 30 days before study begin
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Venenklinik Bellevue
Kreuzlingen, 8280
Kantonsspital Nidwalden
Stans, Ennetmooserstrasse 19, 6370
Spital Männedorf
Zurich, 8708
About this study
Official title: Local Application of Combined Optical and Magnetic Stimulation (COMS) in Patients Suffering From Chronic Wounds at Lower Extremities: Safety Evaluation
The demographic shift and the increasing prevalence of chronic wounds represent major challenges for modern health care systems. Classic chronic wounds (venous ulcer, arterial ulcer, mixed ulcer) persist for months or years with a very slow or even no healing progress. Patients suffer from pain and immobility, which dramatically reduces their quality of life. Complications such as infections or tissue necrosis can lead to a bad outcome and amputation of extremities.
The Pio device offers a non-invasive and non-toxic therapeutic approach. The system combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area. The investigational medical device represents a promising combinational therapeutic approach to synergistically increase the tissues regenerative potential. By stimulating electrophysiological processes at the site of injury, the cells regain its capacity to efficiently regenerate the injured or diseased tissue. It is expected that the patient benefits from a faster healing process, reduced inflammation as well as an improved overall treatment outcome.
- Conditions
- Leg Ulcers Venous, Leg Ulcer Arterial, Leg Ulcer Mixed
- Being tested
- Pio Medical Device
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pio Medical DeviceDevice
The Pio device combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area.
| Study group | Role | What they receive |
|---|---|---|
| Combined SOC/Pio treatment | Experimental | Prospective trial (1 month SOC, 2 month SOC + Pio Medical Device, 1 month SOC follow-up) month, with collection of endpoints every second week Receives: Device: Pio Medical Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse event
The incidence of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The incidence of treatment-emergent adverse events will be compared to the incidence of standard of care emergent adverse events.
Measured: At each visit, up to 16 weeks
Severity of adverse event
The severity of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The severity of treatment-emergent adverse events will be compared to the severity of standard of care emergent adverse events.
Measured: At each visit, up to 16 weeks
Time of occurrence of adverse event
The time of occurrence of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The time of occurrence of treatment-emergent adverse events will be compared to the time of occurrence of standard of care emergent adverse events.
Measured: At each visit, up to 16 weeks
Type of adverse event
The type of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The type of treatment-emergent adverse events will be compared to the type of standard of care emergent adverse events.
Measured: At each visit, up to 16 weeks
Secondary outcomes (2)
Wound area
The wound area will be measured weekly right before the Pio treatment.
Measured: At first visit of the week, before Pio treatment, up to 16 weeks
Wound volume
The wound volume will be measured weekly right before the Pio treatment.
Measured: At first visit of the week, before Pio treatment, up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start25 Apr 2017
- Primary completion4 Jun 2020
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg Ulcers VenousStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piomic Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Venenklinik Bellevue, Kantonsspital Nidwalden, Spital Männedorf
- Responsible party
- Sponsor
- Investigators
- Jürg Traber, Dr. med, Principal investigator, Venenklinik BellevueChristiane Bittner, Dr. med., Principal investigator, Kantonsspital NidwaldenGeorg Liesch, Dr. med, Principal investigator, Spital Männedorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112395
- Sponsor's protocol ID
- COMS_01
- Status last verified
- Oct 2019
- First submitted
- 3 Apr 2017
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Application of Combined Optical and Magnetic Stimulation (COMS) in Patients Suffering From Chronic Wounds at Lower Extremities: Safety Evaluation
- ClinicalTrials.gov ID
- NCT03112395
- Acronym / sponsor ID
- COMS_01
- Conditions
- Leg Ulcers Venous, Leg Ulcer Arterial, Leg Ulcer Mixed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Piomic Medical AGIndustry (pharma, biotech, devices)
- Collaborators
- Venenklinik Bellevue, Kantonsspital Nidwalden, Spital Männedorf
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 13 Apr 2017 (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 demographic shift and the increasing prevalence of chronic wounds represent major challenges for modern health care systems. Classic chronic wounds (venous ulcer, arterial ulcer, mixed ulcer) persist for months or years with a very slow or even no healing progress. Patients suffer from pain and immobility, which dramatically reduces their quality of life. Complications such as infections or tissue necrosis can lead to a bad outcome and amputation of extremities.
The Pio device offers a non-invasive and non-toxic therapeutic approach. The system combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area. The investigational medical device represents a promising combinational therapeutic approach to synergistically increase the tissues regenerative potential. By stimulating electrophysiological processes at the site of injury, the cells regain its capacity to efficiently regenerate the injured or diseased tissue. It is expected that the patient benefits from a faster healing process, reduced inflammation as well as an improved overall treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined SOC/Pio treatment | Experimental | Device: Pio Medical DeviceProspective trial (1 month SOC, 2 month SOC + Pio Medical Device, 1 month SOC follow-up) month, with collection of endpoints every second week |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Male and female patients
- Age: 18 - 90
- Chronic wound (venous ulcer, arterial ulcer, mixed ulcer) since at least 4 weeks
- Wound area minimal 1 cm2, maximal 50 cm2
Key exclusion criteria (8 listed)
- Women who are pregnant
- Known or suspected non-compliance, drug or alcohol abuse,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons,
- Patients with active devices (e.g. Pacemakers and defibrillators, infusion devices, insulin pumps)
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 |
|---|---|---|
| Pio Medical DeviceThe Pio device combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area. | Device | Combined SOC/Pio treatment |
Primary outcome
Incidence of adverse event
Time frame: At each visit, up to 16 weeks
The incidence of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The incidence of treatment-emergent adverse events will be compared to the incidence of standard of care emergent adverse events.
Severity of adverse event
Time frame: At each visit, up to 16 weeks
The severity of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The severity of treatment-emergent adverse events will be compared to the severity of standard of care emergent adverse events.
Time of occurrence of adverse event
Time frame: At each visit, up to 16 weeks
The time of occurrence of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The time of occurrence of treatment-emergent adverse events will be compared to the time of occurrence of standard of care emergent adverse events.
Type of adverse event
Time frame: At each visit, up to 16 weeks
The type of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The type of treatment-emergent adverse events will be compared to the type of standard of care emergent adverse events.
2 secondary outcomes
Wound area
Time frame: At first visit of the week, before Pio treatment, up to 16 weeks
Wound volume
Time frame: At first visit of the week, before Pio treatment, up to 16 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 30 Jun 2020.
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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.
Jürg Traber, Dr. med principal investigator
Venenklinik Bellevue
Christiane Bittner, Dr. med. principal investigator
Kantonsspital Nidwalden
Georg Liesch, Dr. med principal investigator
Spital Männedorf
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pio Medical Device in people with Leg Ulcers Venous and Leg Ulcer Arterial, run by Piomic Medical AG at 3 sites in Switzerland.
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 8 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 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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?
Incidence of adverse event (time frame: At each visit, up to 16 weeks). The study lists 4 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 30 Jun 2020.