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

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.

Conditions

• Leg Ulcers Venous
• Leg Ulcer Arterial
• Leg Ulcer Mixed

Interventions

DEVICE

Pio Medical Device

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

Sponsors & Collaborators

• Venenklinik Bellevue

  collaborator OTHER

• Kantonsspital Nidwalden

  collaborator UNKNOWN

• Spital Männedorf

  collaborator UNKNOWN

• Piomic Medical AG

  lead INDUSTRY

Principal Investigators

• Jürg Traber, Dr. med · Venenklinik Bellevue

• Christiane Bittner, Dr. med. · Kantonsspital Nidwalden

• Georg Liesch, Dr. med · Spital Männedorf

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-25

Primary Completion

2020-06-04

Completion

2020-06-04

Countries

• Switzerland

Study Locations