NCT03112395

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

Completed NA Last updated 30 June 2020

What this trial tests

NA trial testing Pio Medical Device in Leg Ulcers Venous in 36 participants. Completed in 4 June 2020.

Timeline

25 April 2017

Primary endpoint
4 June 2020

4 June 2020

Quick facts

Lead sponsor	Piomic Medical AG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	25 April 2017
Primary completion	4 June 2020
Estimated completion	4 June 2020
Sites	3 locations across Switzerland

Drugs / interventions tested

• Pio Medical Device

Conditions studied

• Leg Ulcers Venous — all drugs for Leg Ulcers Venous →
• Leg Ulcer Arterial — all drugs for Leg Ulcer Arterial →
• Leg Ulcer Mixed — all drugs for Leg Ulcer Mixed →

Sponsor

Piomic Medical AG

Who can join

Adults 18 to 90, any sex, with Leg Ulcers Venous or Leg Ulcer Arterial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Concurrent Optical- and Magnetic-Stimulation-Induced Changes on Wound Healing Parameters, Analyzed by Hyperspectral Imaging: An Exploratory Case Series.
   Traber J, Wild T, Marotz J, Berli MC, et al · · 2023 · cited 4× · PMID 37508777 · DOI 10.3390/bioengineering10070750