Is NCT06810726 recruiting in Corpus Christi, TX?

Yes, NCT06810726 is currently enrolling participants at its Corpus Christi, TX location. This diabetic foot ulcer clinical trial is accepting qualified participants.

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

To join this clinical trial in Corpus Christi, 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 Corpus Christi 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 Corpus Christi, TX (Phase 2)

About This Diabetic Foot Ulcer Study in Corpus Christi

The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2, mild to moderate, neuroischemic diabetic chronic foot ulcers in subjects with Type 1 and Type 2 Diabetes Mellitus. The main question\[s\] it aims to answer \[is/are\]: Measure 1: Wound Closure with Tropocells Autologous PRF System for DFU Measure 2: Safety of Tropocells A

Sponsor: Estar Medical dba Medical Technologies, LTD

Who Can Participate

Inclusion Criteria

Male or female ≥ 18 years of age

Type 1 or Type 2 Diabetes

Grade 2, DFU, non-infected, below the ankle,1.0-12.0 cm2, present ≥ 30 day

Ulcer Size 1.0 cm2 to 12.0 cm2

Wound location will be distal to the malleolus, excluding between the toes, with no exposed capsule, tendon, or bone, and no tunneling, undermining, or sinus tracts, a depth of ≤ 5mm

If more than one non-healing wound is present, the selected ulcer will be the largest and ≥ 1 cm2 in size.

At least 2.0 cm between the index wound and other wounds.

Study ulcer has been present for at least 30 days and has undergone the 14-day

Adequate vascular perfusion of the affected limb, as defined by at least one of the following: Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2, Toe Pressure (TP) ≥ 30 mmHg, Transcutaneous partial pressure of oxygen (TcPO2) ≥ 30 mmHg, or skin perfusion pressure (SPP) ≥ 30 mmHg.

WIFI SCORE- wound grade 1, ischemia grade 0-1, and infection grade 0)

Screening Period of the standard of care with 20% or less wound closure.

No Clinical Signs of Infection at the wound site or the affected limb.

Post-debridement without signs of necrotic tissue.

Normal Platelet count ≥ 105,000 and \<450, 000 (according to CBC)

Hemoglobin (Hgb) ≥10 g/dL and Hematocrit (HCT) ≥ 27% (according to CBC)

Controlled glucose level HbA1C ≤ 12%, with active treatment being conducted to reduce the value to by a primary provider or endocrinologist

No Chronic Renal Failure (CRF); Estimated glomerular filtration rate (eGFR) ≥ 15

PT/PTT - INR between 2.0-3.0 (with blood thinners).

Nutritional Status with no severe protein deficiency, Pre-albumen \>15 mg/dL

Demonstrated adequate offloading using DH Walker boot with Plastazote Insole (OR equivalent off-loading device).

If a female of childbearing potential, must have a negative serum or urine pregnancy test at screening and use contraception or abstinence during trial.

Male subjects agree to use contraception or abstinence during the trial.

The subject has provided written informed consent before any screening procedures and agrees to comply with study procedures and requirements.

Exclusion Criteria

Life expectancy is less than 12 months.

Anemia Hgb ≤ 10 g/dL and HCT ≤ 27%.

Ulcers of other than diabetic foot pathophysiology.

Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days.

Documented sepsis, proven with blood cultures, within 2 weeks of the trial or during the Screening Phase.

Soft tissue infection at the designated ulcer or the same extremity within 2 weeks of the time of screening.

Osteomyelitis at the designated wound site; using ESR ≥ and /or CRP ≥ 7.9 mg/d as a screen.

CKD Level G5: Chronic Renal Failure (CRF) sufficient to require dialysis.

Religious constraints to using blood products, including autologous blood.

Alcohol or substance abuse (other than tobacco) within 2 months before enrollment.

Blood-borne or communicable diseases that would likely prevent full participation in the trial (e.g., HIV, AIDs, COVID, TB).

Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days of initiating the trial.

The subject has severe lymphedema (Stage 3) where the individual cannot lift the extremity on their own secondary to the amount of edema and fluid weight.

The subject is undergoing hemodialysis.

Subjects who are cognitively impaired, unable to understand the informed consent, or have a health care proxy.

Subjects with sickle cell anemia, thrombocytopenia, leukemia, or blood dyscrasia.

History of problems with coagulation, abnormal thrombocytes (platelets), or receiving heparin intravenously; subjects taking coumadin, aspirin, clopidogrel, or other oral anti-coagulants are not excluded.

Anemia where weekly blood draws of 12 or 23 per week may not be tolerated.

Received electrostimulation, hyperbaric treatments, growth factors, or any cell or tissue-derived therapy for any wounds 30 days before entry into the study.

Systemic corticosteroids, (except for subjects receiving inhaled corticosteroid treatments for asthma or COPD) 30 days before entry into the study.

Received within 30 days before the study or scheduled to receive medications or treatments known to interfere with or affect the rate or quality of wound closure (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy within the past 12 months, dialysis, radiation therapy to the treatment area, vascular surgery, angioplasty, or thrombolysis.

Received radiation therapy or chemotherapy within the previous 3 months.

Subjects with known sensitivity to blood components such as those in the PRF kit.

The subject has inadequate venous access for repeated blood draws required for the PRP preparation.

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 Corpus Christi?

Yes, this clinical trial (NCT06810726) has an active research site in Corpus Christi, TX 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 Corpus Christi, TX

If you're searching for diabetic foot ulcer treatment options in Corpus Christi, TX, this clinical trial (NCT06810726) 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 Corpus Christi research site is actively enrolling participants for this phase 2 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 Corpus Christi, TX

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