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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-25

Study Completion Date

2020-06-04

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.

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Detailed Description

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Conditions

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Leg Ulcers Venous Leg Ulcer Arterial Leg Ulcer Mixed

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Pio Medical Device

Intervention Type DEVICE

The Pio device combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area.

Interventions

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Pio Medical Device

The Pio device combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No