TrueLok Elevate transverse bone transport for lower‑limb ulcers
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
This project tests the TrueLok Elevate device in adults with chronic lower‑limb ulcers to see if controlled bone cuts and gradual distraction improve local blood flow and help wounds heal.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 153 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Orthofix s.r.l. Industry-sponsored |
| Locations | 5 sites (Wuppertal and 4 other locations) |
| Trial ID | NCT07079774 on ClinicalTrials.gov |
What this trial studies
This is an observational, multicenter registry of the TrueLok Elevate Transverse Bone Transport System used during indicated surgical care for adults with bony or soft‑tissue defects and chronic lower‑limb ulcers. The device uses a controlled corticotomy and slow transverse distraction to stimulate local vascularization and promote wound healing while patients receive standard postoperative follow‑up. Eligible patients have ulcers present for at least three months that have not responded to standard non‑surgical or surgical wound care. Data will be collected on wound healing, limb salvage, device performance, and safety across participating centers in Europe and South Africa.
Who should consider this trial
Good fit: Adults (18+) with chronic lower‑limb ulcers present ≥3 months that have failed standard non‑surgical or surgical wound treatments and who are indicated for transverse bone transport surgery are the ideal candidates.
Not a fit: Patients who cannot adhere to postoperative care or follow‑up due to cognitive, behavioural, or other medical limitations, or those who respond to standard wound care or are not surgical candidates, are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, this approach could improve local blood flow and help stubborn lower‑limb ulcers close, potentially reducing the need for further surgery or amputation.
How similar studies have performed: Case series and small observational reports of transverse bone transport (including tibial transports) have reported improved wound healing and limb salvage in refractory lower‑limb ulcers, but randomized controlled data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Wuppertal and 4 other locations
- Helios Klinikum Wuppertal GmbH — Wuppertal, Germany (Recruiting)
- General Regional Hospital F. Miulli of Acquaviva delle Fonti — Acquaviva delle Fonti, Bari, Italy (Recruiting)
- Stellenbosch University — Cape Town, Western Cape, South Africa (Recruiting)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
- Hull University Teaching Hospitals NHS Trust — Hull, Hull, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Jay Erturan, MD
- Email: jerturan@orthofix.co.uk
- Phone: 7779 32 32 44
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.