Wound of SkinNCT07079774
TrueLok Elevate PMCF Study
An observational study of Wound of Skin and Ulcers, run by Orthofix s.r.l. at 14 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound of Skin, Ulcers, Soft Tissue Defect
- What is being tested?
- Transverse Bone Transport System
- Type of treatment
- Medical device
- How many people
- 153 participants
- Where
- 14 sitesin 6 countries
- Study dates
- 24 Nov 2025to 24 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by chronic foot ulcers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 6 countries
Italy5 sites, 3 recruiting
- Active, not recruiting
General Regional Hospital F. Miulli of Acquaviva delle Fonti
Acquaviva delle Fonti, Bari
- Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127
Giovanni Guercio, Professor, +390916552600, giovanni.guercio@unipa.it
- Not yet recruiting
Azienda Ospedaliero Universitaria di Parma
Parma, PR, 43126
Francesco Pogliacomi, Professor, +390521703505, francesco.pogliacomi@unipr.it
- Active, not recruiting
Sant'Andrea Hospital - University of Rome "La Sapienza"
Roma, RM, 00189
- Not yet recruiting
San Giovanni Evangelista Hospital
Tivoli, RM, 00019
Antonio Vadalà, MD, +3907743164461, anto.vada76@gmail.com
Germany3 sites, 3 recruiting
- Not yet recruiting
Universitätsklinikum Halle
Halle, 06120
Natalia Gutteck, MD, +4903455574870, natalia.gutteck@uk-halle.de
- Not yet recruiting
Krankenhaus GmbH Landkreis Weilheim-Schongau
Weilheim, 82362
Ludwig Schwering, MD, +498811880, l.schwering@gmx.de
- Recruiting
Helios Klinikum Wuppertal GmbH
Wuppertal
Marco Speicher, MD
Spain2 sites, 2 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Laia Capdevila Lopez, MD, elopezcapdevila@gmail.com
- Recruiting
Hospital Universitario Parc Taulí
Barcelona, 08208
Pau Rigol Ramon, MD, +34 937231010, prigolramon@gmail.com
United Kingdom2 sites, 1 recruiting
- Recruiting
Hull University Teaching Hospitals NHS Trust
Hull
Hermant Sharma, Prof.
- Active, not recruiting
Newcastle's Royal Victoria Infirmary
Newcastle upon Tyne, NE14LP
Slovakia1 site, 1 recruiting
- Not yet recruiting
Fakultná nemocnica s poliklinikou Žilina
Žilina, 01207
Juraj Kacian, MD, +421415110111, kacian73@gmail.com
South Africa1 site, 1 recruiting
- Recruiting
Stellenbosch University
Cape Town, Western Cape, 7505
Nando Ferreira, Prof., nferreira@sun.ac.za
About this study
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
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.
- Conditions
- Wound of Skin, Ulcers, Soft Tissue Defect
- Being tested
- Transverse Bone Transport System
- Medical subject headings
- Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse Bone Transport SystemDevice
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, 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start24 Nov 2025
- Primary completion24 Nov 2028 (estimated)
- Study completion24 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound of SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthofix s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079774
- Sponsor's protocol ID
- CIP-TLEL-25
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07079774
- Acronym / sponsor ID
- CIP-TLEL-25
- Conditions
- Wound of Skin, Ulcers, Soft Tissue Defect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Orthofix s.r.l.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 24 Nov 2028 (estimated)
- Study completion
- 24 Nov 2028 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by chronic foot ulcers
Key inclusion criteria (4 listed)
- 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
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transverse Bone Transport SystemThis 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 | Device | – |
Primary outcome
Complete ulcer healing
Time frame: 12 months
Proportion of subjects achieving complete ulcer healing within 12 months of device removal. Healing is defined as full epithelialisation with no open wound.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound of Skin and Ulcers, run by Orthofix s.r.l. at 14 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy, Germany, Spain, United Kingdom, Slovakia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay Erturan, MD (7779 32 32 44 ext. +44, jerturan@orthofix.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ulcer healing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.