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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03112395
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : June 30, 2020
Sponsor:
Collaborators:
Venenklinik Bellevue
Kantonsspital Nidwalden
Spital Männedorf
Information provided by (Responsible Party):
Piomic Medical AG

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.


Condition or disease Intervention/treatment Phase
Leg Ulcers Venous Leg Ulcer Arterial Leg Ulcer Mixed Device: Pio Medical Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Local Application of Combined Optical and Magnetic Stimulation (COMS) in Patients Suffering From Chronic Wounds at Lower Extremities: Safety Evaluation
Actual Study Start Date : April 25, 2017
Actual Primary Completion Date : June 4, 2020
Actual Study Completion Date : June 4, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Incidence of adverse event [ Time Frame: At each visit, up to 16 weeks ]
    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.

  2. Severity of adverse event [ Time Frame: At each visit, up to 16 weeks ]
    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.

  3. Time of occurrence of adverse event [ Time Frame: At each visit, up to 16 weeks ]
    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.

  4. Type of adverse event [ Time Frame: At each visit, up to 16 weeks ]
    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.


Secondary Outcome Measures :
  1. Wound area [ Time Frame: At first visit of the week, before Pio treatment, up to 16 weeks ]
    The wound area will be measured weekly right before the Pio treatment.

  2. Wound volume [ Time Frame: At first visit of the week, before Pio treatment, up to 16 weeks ]
    The wound volume will be measured weekly right before the Pio treatment.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112395


Locations
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Switzerland
Kantonsspital Nidwalden
Stans, Ennetmooserstrasse 19, Switzerland, 6370
Venenklinik Bellevue
Kreuzlingen, Switzerland, 8280
Spital Männedorf
Zurich, Switzerland, 8708
Sponsors and Collaborators
Piomic Medical AG
Venenklinik Bellevue
Kantonsspital Nidwalden
Spital Männedorf
Investigators
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Principal Investigator: Jürg Traber, Dr. med Venenklinik Bellevue
Principal Investigator: Christiane Bittner, Dr. med. Kantonsspital Nidwalden
Principal Investigator: Georg Liesch, Dr. med Spital Männedorf
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Responsible Party: Piomic Medical AG
ClinicalTrials.gov Identifier: NCT03112395    
Other Study ID Numbers: COMS_01
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: October 2019

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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
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases