Bone transport device aims to heal chronic leg ulcers

NCT ID NCT07079774

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

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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

Contacts and locations

Locations

General Regional Hospital F. Miulli of Acquaviva delle Fonti
RECRUITING

Acquaviva delle Fonti, Bari, Italy
Helios Klinikum Wuppertal GmbH
RECRUITING

Wuppertal, Germany
Hospital de la Santa Creu i Sant Pau
RECRUITING

Barcelona, 08041, Spain
Hull University Teaching Hospitals NHS Trust
RECRUITING

Hull, Hull, United Kingdom
Stellenbosch University
RECRUITING

Cape Town, Western Cape, 7505, South Africa

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