Castro Valley, CANCT05758545Now EnrollingIRB Ready

Diabetic Foot Ulcer Clinical Trial in Castro Valley, CA

Access cutting-edge diabetic foot ulcer treatment through this clinical trial at a research site in Castro Valley. Study-provided care at no cost to qualified participants.

Sponsored by Piomic Medical

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Expert Care in Castro Valley

Access diabetic foot ulcer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related diabetic foot ulcer treatment provided free

Apply for This Castro Valley Location

Check if you qualify for this diabetic foot ulcer clinical trial in Castro Valley, CA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Castro Valley

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Castro Valley site if eligible
  4. 4Begin participation

About This Diabetic Foot Ulcer Study in Castro Valley

The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device through 24 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.

Sponsor: Piomic Medical

Who Can Participate

Inclusion Criteria

Subjects are male or female, ≥22 and ≤90 years of age
Female subjects of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at screening and throughout the duration of their study participation.
The participant (or LAR if applicable) must be able to understand and sign the informed consent form (ICF) and comply with requirements set in the protocol including trial visits, trial treatment and dressing regimens and compliance with required offloading device (if applicable)
Type 1 or Type 2 diabetes mellitus
Presence of one full-thickness DFU located at or below the malleoli (If the subject has more than one DFU that meets eligibility criteria, the investigator will designate one DFU as the target DFU to be treated in the trial)
Wagner Grade 1 or 2 (without bone exposure)
There is a minimum 2 cm margin between the target DFU and any other ulcer on that same foot, post-debridement
Target DFU duration \>30 days and \<52 weeks
Target DFU area between 0.5 - 25 cm2 at screening (Target DFU is ≥ 0.5cm2 after debridement at start of Run-In Phase)
Adequate vascular perfusion of the target limb (same limb as where the target DFU is located) as evidenced by: either a skin perfusion pressure (SPP) measurement of ≥30mmHg OR an ankle-brachial index (ABI) \>0.7 but less than 1.2 or a toe-brachial index (TBI) \>0.4 but less than 1.1 or a transcutaneous oxygen pressure (TcPO2) \>40mmHg

Exclusion Criteria

Known pregnancy or lactating
Active skin cancer, a history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated.
Subject who is taking any medications the Investigator believes may interfere with healing of the target DFU
Subject who is currently undergoing treatment for an active systemic infection, including osteomyelitis
Wagner Grade 3, 4 or 5
Participation in another trial with investigational drug or device within the 30 days preceding and during the present trial
Any co-morbid medical condition which places the subject at unreasonable risks in the opinion of the Investigator
Subject has chronic renal insufficiency requiring dialysis (end stage renal disease)
Subject is being treated with systemic corticosteroids (prednisone, dexamethasone, hydrocortisone, methylprednisolone, or similar) \>10mg/day for more than 10 days or any dose \>30 days
For subjects in the 2-Week Run-In Phase: more than 30% closure of target DFU at Screening Run-In Phase Visit I or Randomization/Baseline Visit or more than 50% closure of target DFU between the 2 Week Historical Period and Randomization/Baseline Visit (measured post-debridement)
For subjects in the 4-Week Run-In Phase: more than 30% closure of target DFU at Screening Run-In Visit II or between Screening Run-In Phase Visit II and Randomization/Baseline Visit or more than 50% closure of target DFU between Screening Run-In Phase Visit I and Randomization/Baseline Visit (measured post-debridement)
Blood chemistry or counts values as follows (based on subject's medical files):
Pre-albumin \<10 mg/dL OR albumin \<2.8 g/dL
Serum BUN \>60 mg/dL
Serum creatinine \>4.0 mg/dL
WBC \<2.0 x 109/L
Hemoglobin \<8.0 g/dL
Absolute neutrophil \<1.0 x 109/L
Platelet count \<50 x 109/L
HbA1C \>12%

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Castro Valley?

Yes, this clinical trial (NCT05758545) has an active research site in Castro Valley, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Diabetic Foot Ulcer Treatment Options in Castro Valley, CA

If you're searching for diabetic foot ulcer treatment options in Castro Valley, CA, this clinical trial (NCT05758545) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Castro Valley research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diabetic foot ulcer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all diabetic foot ulcer clinical trials near you to find additional studies recruiting in your area.

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