NCT07444593

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Biodynamik, Inc · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Diabetic lower extremity ulcers are associated with impaired blood flow, delayed wound healing, high morbidity, and an increased risk of limb loss. In some patients, conventional treatments such as wound care, revascularization procedures, or adjunctive therapies are ineffective or not feasible, leaving limited options short of major amputation. Transverse tibial bone transport (TTT) is a surgical technique that applies controlled distraction to the tibial cortex and has been reported in prior clinical studies to stimulate angiogenesis, improve local perfusion, and support wound healing in ischemic conditions.

Conditions

• Diabetic Foot Ulcer
• Chronic Ulcers of the Lower Limb

Interventions

Type	Name	Description
DEVICE	Biodynamik XT3	Application of XT3 system and transverse tibial bone transport procedure

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-12-31
• Completion: 2027-02-28
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study