πŸ›οΈ Verified NIH Record β€’ Updated 2026-04-22

Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds (NCT07444593)

SMILE - TTT: Surgical MIcrovascularization of Lower Extremities for Diabetic Foot Ulcers - Transverse Tibial Transport Study

🟑 Not Yet Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: Biodynamik, Inc

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic β€” Jacksonville, Florida

Age range: 22 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (1 Sites)

  • Mayo Clinic β€” Jacksonville, Florida

πŸ“ž Contact the Study Coordinator

Phone: (904) 953-2496

Email: Wellings.elizabeth@mayo.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—