Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Bone transport device aims to heal chronic leg ulcers

NCT ID NCT07079774

Disease control Sponsor: Orthofix s.r.l. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study is testing a device called the TrueLok Elevate that uses a technique called transverse bone transport to help heal chronic lower limb ulcers. The device is attached to the leg and slowly moves a piece of bone to stimulate blood flow and tissue healing. Researchers will follow 153 adults for up to 12 months after the device is removed to see if their ulcers heal completely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TrueLok Elevate Transverse Bone Transport System (external fixation device)
What this could lead to
If successful, this device could offer a new way to heal stubborn lower limb ulcers without major surgery, potentially reducing amputations.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. The device requires surgery and a long recovery, and not all ulcers may heal completely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 153 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients affected by chronic foot ulcers

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Lower limb ulcer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

injury ulcer disease ulcer of lower limbs

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Soft tissue defect Ulcers Wound of skin

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    NOT_YET_RECRUITING

    Palermo, 90127, Italy

  • Azienda Ospedaliero Universitaria di Parma

    NOT_YET_RECRUITING

    Parma, PR, 43126, Italy

  • Fakultná nemocnica s poliklinikou Žilina

    NOT_YET_RECRUITING

    Žilina, 01207, Slovakia

  • General Regional Hospital F. Miulli of Acquaviva delle Fonti

    ACTIVE_NOT_RECRUITING

    Acquaviva delle Fonti, Bari, Italy

  • Helios Klinikum Wuppertal GmbH

    RECRUITING

    Wuppertal, Germany

  • Hospital Universitario Parc Taulí

    RECRUITING

    Barcelona, 08208, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • Hull University Teaching Hospitals NHS Trust

    RECRUITING

    Hull, United Kingdom

  • Krankenhaus GmbH Landkreis Weilheim-Schongau

    NOT_YET_RECRUITING

    Weilheim, 82362, Germany

  • Newcastle's Royal Victoria Infirmary

    ACTIVE_NOT_RECRUITING

    Newcastle upon Tyne, NE14LP, United Kingdom

  • San Giovanni Evangelista Hospital

    NOT_YET_RECRUITING

    Tivoli, RM, 00019, Italy

  • Sant'Andrea Hospital - University of Rome "La Sapienza"

    ACTIVE_NOT_RECRUITING

    Roma, RM, 00189, Italy

  • Stellenbosch University

    RECRUITING

    Cape Town, Western Cape, 7505, South Africa

  • Universitätsklinikum Halle

    NOT_YET_RECRUITING

    Halle, 06120, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.