| NCT ID | NCT07079774 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Orthofix s.r.l. |
| Condition | Wound of Skin |
| Study Type | OBSERVATIONAL |
| Enrollment | 153 participants |
| Start Date | 2025-11-24 |
| Primary Completion | 2028-11-24 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 153 participants in total. It began in 2025-11-24 with a primary completion date of 2028-11-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07079774 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Wound of Skin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07079774 currently recruiting?
Yes, NCT07079774 is actively recruiting participants. Contact the research team at jerturan@orthofix.co.uk for enrollment information.
Where is the NCT07079774 trial being conducted?
This trial is being conducted at Wuppertal, Germany, Acquaviva delle Fonti, Italy, Cape Town, South Africa, Barcelona, Spain and 1 additional location.
Who is sponsoring the NCT07079774 clinical trial?
NCT07079774 is sponsored by Orthofix s.r.l.. The trial plans to enroll 153 participants.