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

Study Overview
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Brief Summary
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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.

Official Title
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Local Application of Combined Optical and Magnetic Stimulation (COMS) in Patients Suffering From Chronic Wounds at Lower Extremities: Safety Evaluation

Conditions
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Leg Ulcers Venous, Leg Ulcer Arterial, Leg Ulcer Mixed

Intervention / Treatment
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* Device: Pio Medical Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined SOC/Pio treatment<br>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<br>* The Pio device combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | At each visit, up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound area | The wound area will be measured weekly right before the Pio treatment. | 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. | At first visit of the week, before Pio treatment, up to 16 weeks |