Monroeville, PANCT07086443Now EnrollingIRB Ready

Diabetic Foot Ulcer Clinical Trial in Monroeville, PA

Access cutting-edge diabetic foot ulcer treatment through this phase 4 clinical trial at a research site in Monroeville. Study-provided care at no cost to qualified participants.

Sponsored by Sequence LifeScience, Inc.

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Expert Care in Monroeville

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

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Check if you qualify for this diabetic foot ulcer clinical trial in Monroeville, PA

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Why Participate?

  • No-Cost Study Care

  • Local to Monroeville

    Convenient for PA 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 Monroeville site if eligible
  4. 4Begin participation

About This Diabetic Foot Ulcer Study in Monroeville

The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.

Sponsor: Sequence LifeScience, Inc.

Who Can Participate

Inclusion Criteria

The potential subject must be at least 18 years of age or older.
The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the imaging device length times width.
The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.
The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.
The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
ABI between 0.7 and ≤ 1.3;
TCOM ≥ 40 mmHg;
PVR: biphasic. 8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and

Exclusion Criteria

will be designated as the target ulcer.
The potential subject must have a target ulcer located on the 50% below the malleolus and not on the dorsal toes.
The ulcer must be offloaded for at least 14 days prior to enrollment.
The potential subject must consent to using the prescribed offloading method for the duration of the study.
The potential subject must agree to attend the weekly study visits required by the protocol.
The potential subject must be willing and able to participate in the informed consent process. Exclusion Criteria:
The potential subject is known to have a life expectancy of \< 6 months.
The potential subject's target ulcer is not secondary to diabetes.
The target ulcer is infected or there is cellulitis in the surrounding skin.
The target ulcer exposes tendon or bone.
There is evidence of osteomyelitis complicating the target ulcer.
The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.
The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
The potential subject has end stage renal disease requiring dialysis.
The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
The potential subject has a malnutrition.
The potential subject has a known allergy or sensitivity to PBS, IPA, processing solutions, reagents, or latex.

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 Monroeville?

Yes, this clinical trial (NCT07086443) has an active research site in Monroeville, PA 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 Monroeville, PA

If you're searching for diabetic foot ulcer treatment options in Monroeville, PA, this clinical trial (NCT07086443) 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 Monroeville research site is actively enrolling participants for this phase 4 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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