TrueLok Elevate transverse bone transport for lower‑limb ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Helios Klinikum Wuppertal GmbH
  Wuppertal, Germany Recruiting
• Stellenbosch University
  Cape Town, Western Cape, South Africa Recruiting
• Hospital de la Santa Creu i Sant Pau
  Barcelona, Spain Recruiting
• Hospital Universitario Parc Taulí
  Barcelona, Spain Recruiting
• Hull University Teaching Hospitals NHS Trust
  Hull, United Kingdom Recruiting
• Universitätsklinikum Halle
  Halle, Germany Not yet recruiting

Study contacts

• Study coordinator: Jay Erturan, MD
• Email: jerturan@orthofix.co.uk
• Phone: 7779 32 32 44

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.