Local Application of Combined Optical and Magnetic Stimulation (COMS) for Treatment of Chronic Wounds: Safety Evaluation
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ClinicalTrials.gov Identifier: NCT03112395 |
Recruitment Status :
Completed
First Posted : April 13, 2017
Last Update Posted : June 30, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leg Ulcers Venous Leg Ulcer Arterial Leg Ulcer Mixed | Device: Pio Medical Device | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Local Application of Combined Optical and Magnetic Stimulation (COMS) in Patients Suffering From Chronic Wounds at Lower Extremities: Safety Evaluation |
Actual Study Start Date : | April 25, 2017 |
Actual Primary Completion Date : | June 4, 2020 |
Actual Study Completion Date : | June 4, 2020 |

Arm | Intervention/treatment |
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Experimental: Combined SOC/Pio treatment
Prospective trial (1 month SOC, 2 month SOC + Pio Medical Device, 1 month SOC follow-up) month, with collection of endpoints every second week
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Device: Pio Medical Device
The Pio device combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area. |
- 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.
- Wound area [ Time Frame: At first visit of the week, before Pio treatment, up to 16 weeks ]The wound area will be measured weekly right before the Pio treatment.
- Wound volume [ Time Frame: At first visit of the week, before Pio treatment, up to 16 weeks ]The wound volume will be measured weekly right before the Pio treatment.

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112395
Switzerland | |
Kantonsspital Nidwalden | |
Stans, Ennetmooserstrasse 19, Switzerland, 6370 | |
Venenklinik Bellevue | |
Kreuzlingen, Switzerland, 8280 | |
Spital Männedorf | |
Zurich, Switzerland, 8708 |
Principal Investigator: | Jürg Traber, Dr. med | Venenklinik Bellevue | |
Principal Investigator: | Christiane Bittner, Dr. med. | Kantonsspital Nidwalden | |
Principal Investigator: | Georg Liesch, Dr. med | Spital Männedorf |
Responsible Party: | Piomic Medical AG |
ClinicalTrials.gov Identifier: | NCT03112395 |
Other Study ID Numbers: |
COMS_01 |
First Posted: | April 13, 2017 Key Record Dates |
Last Update Posted: | June 30, 2020 |
Last Verified: | October 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Varicose Ulcer Leg Ulcer Ulcer Pathologic Processes Skin Ulcer |
Skin Diseases Varicose Veins Vascular Diseases Cardiovascular Diseases |