Local Application of Combined Optical and Magnetic Stimulation (COMS) for Treatment of Chronic Wounds: Safety Evaluation

• ClinicalTrials.gov Identifier: NCT03112395
• Recruitment Status: Completed
• First Posted: April 13, 2017
• Last Update Posted: June 30, 2020
• Sponsor: Piomic Medical AG
• Collaborators: Venenklinik Bellevue; Kantonsspital Nidwalden; Spital Männedorf
• Information provided by (Responsible Party): Piomic Medical AG

Study Description

Brief 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. 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 Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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	Device: Pio Medical Device; The Pio device combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Switzerland

Kantonsspital Nidwalden

Stans, Ennetmooserstrasse 19, Switzerland, 6370

Venenklinik Bellevue

Kreuzlingen, Switzerland, 8280

Spital Männedorf

Zurich, Switzerland, 8708

Sponsors and Collaborators

Piomic Medical AG

Venenklinik Bellevue

Kantonsspital Nidwalden

Spital Männedorf

Investigators

• Principal Investigator: Jürg Traber, Dr. med; Venenklinik Bellevue
• Principal Investigator: Christiane Bittner, Dr. med.; Kantonsspital Nidwalden
• Principal Investigator: Georg Liesch, Dr. med; Spital Männedorf

More Information

• Responsible Party: Piomic Medical AG
• ClinicalTrials.gov Identifier: NCT03112395
• Other Study ID Numbers: COMS_01
• First Posted: April 13, 2017
• 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

Additional relevant MeSH terms:

Varicose Ulcer; Leg Ulcer; Ulcer; Pathologic Processes; Skin Ulcer; Skin Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases