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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Biodynamik, Inc
Study ID
NCT07444593
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biodynamik XT3 — DEVICE
    Application of XT3 system and transverse tibial bone transport procedure

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of Care (control)
    Standard Wound Care
  • Experimental: Standard Wound Care plus TTT

Primary Outcome Measure

Proportion of subjects with wound closure [ Time Frame: From enrollment to 18 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicJacksonvilleFlorida32224
Lauren Evans
[email protected]
904-953-5416
Bre Jenkins
[email protected]
Elizabeth Wellings, MD (PRINCIPAL_INVESTIGATOR)
Thea Price, MD (SUB_INVESTIGATOR)

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By research site
Mayo Clinic· Jacksonville, FL

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