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Concurrent optical and magnetic stimulation for treatment of refractory diabetic foot ulcer

  • Status
    Accepting Candidates
  • Age
    22 Years - 90 Years
  • Sexes
    All
  • Healthy Volunteers
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Description

The purpose of this study is to evaluate the COMS One Therapy System in combination with standard of care treatment to treat long-term diabetic foot ulcers compared to standard of care treatment alone. Changes in ulcer healing will be evaluated before, during, and after treatment with the device. The COMS One Therapy System is currently approved for use in Europe, but has not yet been approved in the US by the Food and Drug Administration (FDA); therefore, while the device is being used in the US it will be considered investigational. The study will be conducted in 15-20 sites across the US, and a total of 224 patients will be enrolled in the trial. If you decide to take part in this study, you will be assigned to one of two possible treatments.

Active study treatment with the COMS One Therapy System and standard of care treatment

OR

Placebo, also known as a sham device, and standard of care treatment. The Sham device was designed to look identical to the COMS One device.

Details

Protocol number COMS_03

Eligibility

Inclusion criteria:

  1. Type 1 or Type 2 diabetes mellitus
  2. Presence of one full-thickness diabetic foot ulcer located at or below the malleoli that does not have bone exposure and has been present for >30 days but 10mg/day for more than 10 days or any dose >30days
  3. Lab values that do not meet study criteria

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.