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

NCT03112395 | Completed DMC

• 1 other identifier: COMS_01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Wound area

  At first visit of the week, before Pio treatment, up to 16 weeks

• Wound volume

  At first visit of the week, before Pio treatment, up to 16 weeks

Study Arms (1)

Combined SOC/Pio treatment

EXPERIMENTAL

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

Interventions

Pio Medical Device DEVICE

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

Combined SOC/Pio treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Piomic Medical AG: lead
• Venenklinik Bellevue: collaborator
• Kantonsspital Nidwalden: collaborator
• Spital Männedorf: collaborator

Study Sites (3)

Kantonsspital Nidwalden

Stans, Ennetmooserstrasse 19, 6370, Switzerland

Location

Venenklinik Bellevue

Kreuzlingen, 8280, Switzerland

Location

Spital Männedorf

Zurich, 8708, Switzerland

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jürg Traber, Dr. med

  Venenklinik Bellevue

  PRINCIPAL INVESTIGATOR

• Christiane Bittner, Dr. med.

  Kantonsspital Nidwalden

  PRINCIPAL INVESTIGATOR

• Georg Liesch, Dr. med

  Spital Männedorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 13, 2017
• Study Start: April 25, 2017
• Primary Completion: June 4, 2020
• Study Completion: June 4, 2020
• Last Updated: June 30, 2020

Record last verified: 2019-10

Locations

CH (3)