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

Leg Ulcers Venous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112395
• Other study ID #: COMS_01
• Status: Completed
• Phase: N/A
• Start date: April 25, 2017
• Est. completion date: June 4, 2020

Study information

• Verified date: October 2019
• Source: Piomic Medical AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 4, 2020
• Est. primary completion date: June 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Switzerland	Venenklinik Bellevue	Kreuzlingen
Switzerland	Kantonsspital Nidwalden	Stans	Ennetmooserstrasse 19
Switzerland	Spital Männedorf	Zurich

Sponsors (4)

Lead Sponsor	Collaborator
Piomic Medical AG	Kantonsspital Nidwalden, Spital Männedorf, Venenklinik Bellevue

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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