Clinical trial NCT03112395: Local Application of Combined Optical and Magnetic Stimulation (COMS) for Treatment of Chronic Wounds: Safety Evaluation
Official title: Local Application of Combined Optical and Magnetic Stimulation (COMS) in Patients Suffering From Chronic Wounds at Lower Extremities: Safety Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Ulcers Venous
Leg Ulcer Arterial
Leg Ulcer Mixed
Lead sponsor: Piomic Medical AG
Sponsor class: INDUSTRY
Collaborators: name: Venenklinik Bellevue
name: Kantonsspital Nidwalden
name: Spital Männedorf
First posted: 2017-04-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse event
timeFrame: At each visit, up to 16 weeks
measure: Severity of adverse event
timeFrame: At each visit, up to 16 weeks
measure: Time of occurrence of adverse event
timeFrame: At each visit, up to 16 weeks
measure: Type of adverse event
timeFrame: At each visit, up to 16 weeks
Secondary outcomes:
measure: Wound area
timeFrame: At first visit of the week, before Pio treatment, up to 16 weeks
measure: Wound volume
timeFrame: At first visit of the week, before Pio treatment, up to 16 weeks
Other outcomes:
Locations:
city: Stans
country: Switzerland
facility: Kantonsspital Nidwalden
state: Ennetmooserstrasse 19
city: Kreuzlingen
country: Switzerland
facility: Venenklinik Bellevue
city: Zurich
country: Switzerland
facility: Spital Männedorf
Study officials:
affiliation: Venenklinik Bellevue
name: Jürg Traber, Dr. med
role: PRINCIPAL_INVESTIGATOR
affiliation: Kantonsspital Nidwalden
name: Christiane Bittner, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Spital Männedorf
name: Georg Liesch, Dr. med
role: PRINCIPAL_INVESTIGATOR
References: