TrueLok Elevate PMCF Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOrthofix s.r.l.
About this trial
The TrueLok Elevate Transverse Bone Transport System is a modular external fixation device designed for transverse bone transport. It promotes local vascular and wound healing through controlled corticotomy and gradual distraction. The system is intended for adult patients with bony and/or soft tissuedefects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Present for at least 3 months, and
Unresponsive to standard non-surgical or surgical wound management, including but not limited to debridement, negative pressure wound therapy (VAC), offloading, antibiotics, or vascular optimisation
Disqualifiers
Heart rate >90 beats/min
Respiratory rate >20 breaths/min
PaCO2 <32-mm Hg
White blood cell count >12.000 or <4.000/cu mm
Trial population
Patients affected by chronic foot ulcers
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Transverse Bone Transport System
DeviceThis is a prospective, international, multicentre, observational post-market clinical follow-up (PMCF) study. Adult subjects will be treated according to the manufacturer's Instructions for Use, with follow-up extending to 12 months post-device removal. Participating sites include centres in the US, Europe, the UK, and South Africa. Subjects will be followed using a phased framework: T0: Index Surgery (baseline data, operative details, ulcer status) T1: End of Distraction (device parameters, adverse events, ulcer status) T2: End of Compression (similar to T1) T3: Device Removal (confirmation of union, ulcer status) Post-removal visits: F3: 3 months F6: 6 months F12: 12 months
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Complete ulcer healing
Proportion of subjects achieving complete ulcer healing within 12 months of device removal. Healing is defined as full epithelialisation with no open wound.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov