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

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.

Study Overview

• Status: Completed
• Conditions: Leg Ulcers Venous; Leg Ulcer Arterial; Leg Ulcer Mixed
• Intervention / Treatment: Device: Pio Medical Device

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Kreuzlingen, Switzerland, 8280
    • Venenklinik Bellevue
  • Zurich, Switzerland, 8708
    • Spital Männedorf
  • Ennetmooserstrasse 19
    • Stans, Ennetmooserstrasse 19, Switzerland, 6370
      • Kantonsspital Nidwalden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Device: Pio Medical Device; The Pio device combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Piomic Medical AG
• Collaborators: Venenklinik Bellevue; Kantonsspital Nidwalden; Spital Männedorf
• Investigators: Principal Investigator: Jürg Traber, Dr. med, Venenklinik Bellevue; Principal Investigator: Christiane Bittner, Dr. med., Kantonsspital Nidwalden; Principal Investigator: Georg Liesch, Dr. med, Spital Männedorf

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2017
• Primary Completion (ACTUAL): June 4, 2020
• Study Completion (ACTUAL): June 4, 2020

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (ACTUAL): April 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 28, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: COMS_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No