Jacksonville, FLNCT07444593Now EnrollingIRB Ready

Diabetic Foot Ulcer Clinical Trial in Jacksonville, FL

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

Sponsored by Biodynamik, Inc

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Expert Care in Jacksonville

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 Jacksonville, FL

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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 Jacksonville

    Convenient for FL 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 Jacksonville site if eligible
  4. 4Begin participation

About This Diabetic Foot Ulcer Study in Jacksonville

The purpose of this study is to evaluate the safety and clinical performance of transverse tibial bone transport in patients with chronic ischemic and diabetic lower extremity ulcers. This study will assess wound healing outcomes and limb preservation in a population with limited therapeutic alternatives.

Sponsor: Biodynamik, Inc

Who Can Participate

Inclusion Criteria

Adults (\>=22 years).
Chronic diabetic foot ulcer wound persisting \>=12 weeks and less than 104 weeks refractory to standard wound care.
Wound location within distal 1/3 tibia and below including foot.
Wound stages: WiFi \>= 3
At least one patent lower extremity tibial vessel (after revascularization if needed).
Able to provide informed consent and comply with study procedures.

Exclusion Criteria

Active systemic infection (positive blood cultures)
Severe sepsis (2 out of 4 SIRS criteria with impact on organ dysfunction)
Subacute lower extremity wound \<12 weeks with or without standard wound cares
Internal hardware within 10cm of possible TTT placement
Most proximal aspect of wound within 10cm of most distal pin of possible TTT placement
End Stage Renal Disease requiring dialysis
Renal function values
eGFR: \<15ml/min and
Creatinine: \>6mg/dL and
BUN: \>50 mg/dL
Lab values of Serum albumin less than 2.5 g/dL or hemoglobin less than 8.0 g/dL or platelet count less than 75,000/μL
Wounds less than 1 cm3 or greater than 30 cm3
Wounds that are circumferential as defined as a wound involving 360° of the limb circumference, with complete circumferential wounds defined as 360° involvement.
Corticosteroids \>10mg prednisone equivalent daily for \>2 weeks
Patients with osteomyelitis in the ipsilateral tibia at planned corticotomy site
TNF-inhibitors or JAK inhibitors or chemotherapy-dose methotrexate
Cognitive or social limitations precluding consent or follow-up
Current participation in another investigational study (drug or device)
Immunocompromised (WBC \<4) or undergoing active chemotherapy
Hemoglobin A1c \>10
BMI \<18.5 kg/m2
Pregnant, lactating, or planning to become pregnant
Severe hepatic impairment defined by patient on a transplant list, MELD \> 20 or Child's class C.
A history of conditions that may impair wound healing in the opinion of the Investigator, for example, autoimmune disorders, renal failure patients on dialysis, or medications that impair the healing process.
Active local wound infection as defined by erythema greater than 0.5 cm from the wound margin AND at least one other localized sign of inflammation (purulent discharge, induration, localized warmth, or pain/tenderness)
Life expectancy less than 12 months

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 Jacksonville?

Yes, this clinical trial (NCT07444593) has an active research site in Jacksonville, 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 Treatment Options in Jacksonville, FL

If you're searching for diabetic foot ulcer treatment options in Jacksonville, FL, this clinical trial (NCT07444593) 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 Jacksonville 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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