RecruitingOBSERVATIONAL

TrueLok Elevate PMCF Study

This study is called the TrueLok Elevate PMCF Study and it is looking at a device designed to help heal serious skin wounds, ulcers, and fix body tissue problems. This device, called the TrueLok Elevate Transverse Bone Transport System, is a special kind of frame that helps mend bones and soft tissues. It works by gently stretching the bone after a small cut, which encourages the body to heal itself and grow new tissue. This study focuses on adult patients who have long-lasting ulcers on their lower leg that haven't responded to normal treatments. The aim is to see how well this system helps these serious wounds heal and if it helps the surrounding tissue improve.

At a glance

Status

Recruiting

Sponsor

Orthofix s.r.l.

Enrolment target

153

Start

24 Nov 2025

Estimated completion

24 Nov 2028

Wound of Skin Ulcers Soft Tissue Defect

What is this study about?

This study is about a medical device called the TrueLok Elevate Transverse Bone Transport System. It's like an external frame that's used to help with difficult skin wounds, ulcers, and other tissue problems. Imagine you have a gap in your bone or a big wound that isn't healing. This system works by gently pulling apart a small cut made in the bone. This slow, controlled stretching encourages the bone to grow new tissue to fill the gap, and also helps the surrounding soft tissue heal better by improving blood flow.

The main aim of this study is to see how well this TrueLok Elevate system works in real-world use for adult patients. They are particularly interested in people with long-lasting ulcers on their lower legs – these are wounds that have been there for at least three months and haven't gotten better with regular treatments like special dressings, therapies to reduce pressure, or antibiotics. The study wants to understand if this system can effectively help these stubborn wounds close and improve the overall health of the affected area.

This is not a study comparing a new treatment to an old one; rather, it’s a study observing how a specific device performs in patients under normal care when treating these difficult conditions. If you have been told by your doctor that this treatment might be suitable for your non-healing ulcer, this study might be an option to consider. It’s about ensuring this medical device is working as expected and providing good results for patients.

Key takeaways

This study evaluates a device called TrueLok Elevate for severe skin and bone problems.
It aims to help heal long-lasting lower leg ulcers that haven't improved with standard care.
Participation involves surgery to fit the device, followed by regular check-ups.
Open to adults aged 18+ with specific chronic wound conditions.
Potential benefits include improved wound healing, but risks will be explained.
You can withdraw from the study at any time without affecting your medical treatment.

Who may be eligible?

To be part of this study, you need to be an adult aged 18 or older. You must also be able to understand the study information and give your consent (permission) to take part. It's important that you also agree to follow the study plan, including attending any follow-up appointments. The main reason for joining is if your doctor believes the TrueLok Elevate system is the right treatment for a long-lasting ulcer on your lower leg.

Your ulcer must have been present for at least three months and not have improved with standard treatments like special dressings, pressure relief, antibiotics, or other common therapies. Your doctor will assess whether your specific condition fits all these requirements.

There are also some reasons why you might not be able to join. For example, if you have mental health conditions that would make it hard to follow instructions, or if you have certain serious infections or allergies to the materials used in the TrueLok Elevate system (such as stainless steel or titanium). You also can't be taking part in another study that might interfere with this one, have certain serious medical illnesses, an active cancer that is spreading, or a very short life expectancy.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a chronic (long-standing) ulcer on your lower leg that has been there for at least 3 months?
Has your ulcer not responded well to usual treatments like special dressings or antibiotics?
Are you able to attend follow-up appointments and understand study requirements?
Do you have any known allergies to stainless steel or titanium?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement would begin with signing a consent form after discussing it thoroughly with the study team. The main part of your participation would involve undergoing the surgical procedure to have the TrueLok Elevate device fitted, as recommended by your doctor for your lower leg ulcer. Following the surgery, you would have regular follow-up appointments to monitor your healing process and the device.

At these appointments, the study team would check your wound, the device, and your general health. They might take measurements, photos, or ask you questions about how you are feeling and managing. While the study doesn't involve any special medications, you would continue with any prescribed treatments for your ulcer or other conditions as advised by your doctor.

The total length of your participation would depend on your individual healing process and the study's follow-up schedule. The study aims to track the device's performance over time, so regular visits would be an important part of your commitment. The study team will explain the specific schedule of visits and the assessments involved during each one.

Potential risks and benefits

Participating in this study means you would be receiving the TrueLok Elevate system, which your doctor believes could help heal your long-lasting lower leg ulcer that hasn't responded to other treatments. The potential benefit is better wound healing and improvement in your condition. However, as with any medical procedure or device, there are potential risks, such as infection, pain, discomfort from the device, or problems with the bone healing. All these risks would be fully explained to you before you agree to participate. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Helios Klinikum Wuppertal GmbH
Verified postcode
Wuppertal, Germany· Recruiting
General Regional Hospital F. Miulli of Acquaviva delle Fonti
Verified postcode
Acquaviva delle Fonti, Italy· Recruiting
Stellenbosch University
Verified postcode
Cape Town, South Africa· Recruiting
Hospital de la Santa Creu i Sant Pau
Verified postcode
Barcelona, Spain· Recruiting
Hull University Teaching Hospitals NHS Trust
Verified postcode
Hull, United Kingdom· Recruiting

Common questions

What is TrueLok Elevate?

It's a medical device, a special external frame, used to help heal serious skin wounds, ulcers, and fix problems with bones and soft tissues, particularly on the lower leg.

Who is this study for?

It's for adults aged 18 and over who have a long-lasting ulcer on their lower leg that hasn't healed despite other usual treatments.

What happens if I join the study?

You would have surgery to fit the TrueLok Elevate device, and then have regular check-ups to monitor your healing and how the device is working.

Are there any side effects or risks?

As with any medical treatment, there can be risks like infection, pain, or issues with healing. These will be fully discussed with you by your medical team.

Can I leave the study at any time?

Yes, you are free to stop participating in the study at any point, and this won't affect your ongoing medical care.

How to find out more

Jay Erturan, MD

jerturan@orthofix.co.uk 7779 32 32 44 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.