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Recruiting NCT07079774

TrueLok Elevate PMCF Study

— Observational Wound of Skin Ulcers Soft Tissue Defect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transverse Bone Transport System.
Who it may be relevant to
Registry conditions: Wound of Skin, Ulcers, Soft Tissue Defect. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Italy, South Africa, Spain, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Transverse Bone Transport System
    This 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, a

Primary outcome measures

  • Complete ulcer healing [Time frame: 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Helios Klinikum Wuppertal GmbH — Wuppertal
Italy · 1 center
  • General Regional Hospital F. Miulli of Acquaviva delle Fonti — Acquaviva delle Fonti
South Africa · 1 center
  • Stellenbosch University — Cape Town
Spain · 1 center
  • Hospital de la Santa Creu i Sant Pau — Barcelona
United Kingdom · 1 center
  • Hull University Teaching Hospitals NHS Trust — Hull

Identifiers

NCT: NCT07079774 · CIP-TLEL-25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗