Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorBiodynamik, Inc
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Biodynamik XT3
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Biodynamik, Inc
Lead sponsor
Mayo Clinic
Collaborator
Source ClinicalTrials.gov