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Completed

NCT Number: NCT03112395

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

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Key information

Conditions

Leg Ulcers Venous Cardiovascular Diseases Leg Ulcer Leg Ulcer Arterial Leg Ulcer Mixed Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Nidwalden, Stans, Ennetmooserstrasse 19, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pio Medical Device

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Piomic Medical AG

Industry

Collaborators

  • Kantonsspital Nidwalden
  • Spital Männedorf
  • Venenklinik Bellevue

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2017
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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