TrueLok Elevate PMCF Study

Post-Market Clinical Follow-up Study of the TrueLok Elevate Transverse Bone Transport System for the Treatment of Lower Limb Ulcers as Soft Tissue Defects

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.

Study Overview

• Status: Recruiting
• Conditions: Wound of Skin; Ulcers; Soft Tissue Defect
• Intervention / Treatment: Device: Transverse Bone Transport System

• Study Type: Observational
• Enrollment (Estimated): 153

Contacts and Locations

• Study Contact: Name: Jay Erturan, MD; Phone Number: +44 7779 32 32 44; Email: jerturan@orthofix.co.uk
• Study Contact Backup: Name: Daniela Cangiano, PhD; Phone Number: +39 0456719000; Email: danielacangiano@orthofix.it

Study Locations

• Germany
  • Wuppertal, Germany
    • Recruiting
    • HELIOS Klinikum Wuppertal GmbH
    • Contact: Marco Speicher, MD
• Italy
  • Bari
    • Acquaviva delle Fonti, Bari, Italy
      • Recruiting
      • General Regional Hospital F. Miulli of Acquaviva delle Fonti
      • Contact: Nicola Tartaglia, MD
• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7505
      • Recruiting
      • Stellenbosch University
      • Contact: Nando Ferreira, Prof.; Email: nferreira@sun.ac.za
• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Laia Capdevila Lopez, MD; Email: elopezcapdevila@gmail.com
• United Kingdom
  • Hull
    • Hull, Hull, United Kingdom
      • Recruiting
      • Hull University Teaching Hospitals NHS Trust
      • Contact: Hermant Sharma, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients affected by chronic foot ulcers

Description

Inclusion Criteria:

Aged 18 years or older at the time of surgery Willing and able to sign and date the study-specific informed consent form in accordance with national and institutional ethics requirements Willing and able to comply with requirements of the protocol, including follow-up requirements Indicated for surgical intervention using the TrueLok Elevate Transverse Bone Transport System for the treatment of soft tissue defects in the form of lower limb ulcers

Presence of a chronic ulcer, defined as:

• 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

Exclusion Criteria:

Mental or cognitive impairment or physiological or behavioural conditions that, in the opinion of the investigator, would preclude reliable adherence to postoperative care instructions, follow-up assessments, or study procedures

Known or presenting with the following signs of a systemic inflammatory response syndrome (SIRS) as exhibiting two or more of the following conditions:

o

• 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
• 10% immature (band) forms Known hypersensitivity or allergy to any material used in the TrueLok Elevate Transverse Bone Transport System (e.g., stainless steel, titanium) Current participation in another interventional clinical study that, in the opinion of the investigator, may interfere with the objectives or outcomes of this study Presence of active malignancy or systemic infection that, in the investigator's opinion, may interfere with wound healing or the study protocol Life expectancy of less than 12 months Simultaneous bilateral application of the TrueLok Elevate Transverse Bone Transport System Current incarceration at the time of enrolment Any condition or clinical circumstance that, in the opinion of the investigator, would make participation not in the best interest of the subject or would interfere with the study objectives

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Orthofix s.r.l.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): November 24, 2028
• Study Completion (Estimated): November 24, 2028

Study Registration Dates

• First Submitted: July 3, 2025
• First Submitted That Met QC Criteria: July 14, 2025
• First Posted (Actual): July 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ulcer
• Other Study ID Numbers: CIP-TLEL-25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No