TrueLok Elevate PMCF Study

Launched by ORTHOFIX S.R.L. · Jul 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment device called the TrueLok Elevate Transverse Bone Transport System, which is designed to help heal long-lasting wounds or ulcers on the lower legs, especially those related to diabetes or other soft tissue damage. The device works by gently moving small sections of bone to improve blood flow and support healing in the affected area. This study is for adults who have had ulcers for at least three months that haven’t improved with usual treatments like wound cleaning, pressure relief, or antibiotics.

Adults aged 18 and older who need surgery using this device to treat stubborn leg ulcers might be eligible to join. Participants will need to agree to follow study instructions and attend follow-up visits after surgery. People with certain health issues, such as infections that affect the whole body, allergies to the device materials, or other serious conditions, may not be able to take part. The study is not yet recruiting, but if you qualify and join, you can expect to receive this specialized treatment and regular care as part of the trial to see how well the device helps wounds heal.

Gender

ALL

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