Is NCT06681428 recruiting in Miami, FL?

Yes, NCT06681428 is currently recruiting participants at its Miami, FL location. This diabetic foot ulcer (dfu) clinical trial is actively enrolling qualified participants.

How do I join the diabetic foot ulcer (dfu) clinical trial in Miami?

To join this clinical trial in Miami, 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 Miami 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 (DFU) Clinical Trial in Miami, FL

About This Diabetic Foot Ulcer (DFU) Study in Miami

The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.

Sponsor: Tides Medical

Who Can Participate

Inclusion Criteria

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

At least 18 years old, inclusive.

Presence of a DFU, Wagner Grade 1, extending through the dermis provided it is below the medial aspect of the malleolus.

The index ulcer (ulcer to be evaluated in the study) will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.

Index ulcer has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.

Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.

Within 3 months of SV1, adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 using the affected study extremity. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \> 0.6 is acceptable.

The target ulcer has been offloaded for at least 14 days, prior to TV1.

Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.

Subject understands and is willing to participate in the clinical study and can comply with weekly visits.

Subjects must have read and signed the IRB approved ICF before screening procedures are performed.

Exclusion Criteria

Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent treatment.

Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes

Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer

Index ulcer is infected

Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study

Subjects on any investigational drug(s), Investigational products, or therapeutic device(s) within 30 days preceding SV1

History of radiation at the ulcer site (regardless of time since last radiation treatment)

Index ulcer has been previously treated or will need to be treated with any prohibited therapies

Subjects with a previous diagnosis of HIV or Hepatitis C

Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment

Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision)

Subject is pregnant or breast-feeding

Presence of diabetes with poor metabolic control as documented with an HbA1c \>12.0 within last 90 days

Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of enrollment

Presence of acute Charcot Neuroarthropathy to the affected limb

Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit

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 Miami?

Yes, this clinical trial (NCT06681428) has an active research site in Miami, FL 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 (DFU) Treatment Options in Miami, FL

If you're searching for diabetic foot ulcer (dfu) treatment options in Miami, FL, this clinical trial (NCT06681428) 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 Miami research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diabetic foot ulcer (dfu) 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 (dfu) clinical trials near you to find additional studies recruiting in your area.

Diabetic Foot Ulcer (DFU) Clinical Trial in Miami, FL

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