NCT03112395

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Piomic Medical AG · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Pio Medical Device	The Pio device combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area.

Timeline

• Start date: 2017-04-25
• Primary completion: 2020-06-04
• Completion: 2020-06-04
• First posted: 2017-04-13
• Last updated: 2020-06-30

Locations

3 sites across 1 country: Switzerland