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

NCT07444593 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-27

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer
  • Chronic Ulcers of the Lower Limb

Interventions

DEVICE

Biodynamik XT3

Application of XT3 system and transverse tibial bone transport procedure

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Biodynamik, Inc

    lead INDUSTRY

Principal Investigators

  • Elizabeth Wellings · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-12-31
Completion
2027-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07444593 on ClinicalTrials.gov