Is NCT06437028 recruiting in Monroe, NC?

Yes, NCT06437028 is currently recruiting participants at its Monroe, NC location. This diabetic foot ulcer clinical trial is actively enrolling qualified participants.

How do I join the diabetic foot ulcer clinical trial in Monroe?

To join this clinical trial in Monroe, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Monroe clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Diabetic Foot Ulcer Clinical Trial in Monroe, NC

About This Diabetic Foot Ulcer Study in Monroe

The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment. One ulcer on each participant's foot will receive weekly 1) applications of perinatal tissue allografts and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.

Sponsor: Samaritan Biologics

Who Can Participate

Inclusion Criteria

Potential subjects are required to meet all the following criteria for enrollment in the study.

Subjects must be at least 18 years of age or older.

Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.

At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.

The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.

The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.

The target ulcer must be 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 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.

If the 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.

Target ulcers located on the plantar aspect of the foot 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: Potential subjects meeting any of the following criteria will be excluded from enrollment in the study.

A subject known to have a life expectancy of \< 6 months is excluded.

The subject is excluded if the target ulcer is not secondary to diabetes.

If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.

If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.

A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.

A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.

The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.

A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.

The subject is excluded if the surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).

The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1/randomization visit, during which time the subject received SOC.

The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.

A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.

Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.

A potential subject with end stage renal disease requiring dialysis is excluded.

Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.

A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.

A Subject treated with hyperbaric oxygen therapy or a Cellular Acellular, or Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit is excluded.

A subject is excluded if they are malnourished: a score of less than 17 on the Mini Nutritional Assessment (MNA).

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 Monroe?

Yes, this clinical trial (NCT06437028) has an active research site in Monroe, NC 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 Monroe, NC

If you're searching for diabetic foot ulcer treatment options in Monroe, NC, this clinical trial (NCT06437028) 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 Monroe 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.

Diabetic Foot Ulcer Clinical Trial in Monroe, NC

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