Axoguard Nerve Cap for Amputation Recovery
(REPOSE-XL℠ Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention to the nerve injuries is not possible.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are undergoing treatments like chemotherapy or radiation therapy, or if you are immunosuppressed, you would not be eligible to participate.
Is Axoguard Nerve Cap generally safe for human use?
Previous studies on Axoguard nerve wrap, which is similar to Axoguard Nerve Cap, have shown no safety concerns, with no reported cases of infection, persistent inflammation, or recurrent issues. However, there was a case of necrotic granulomatous inflammation (a type of tissue reaction) reported after its use, indicating that while generally safe, there may be rare adverse reactions.12345
How is the Axoguard Nerve Cap treatment different from other treatments for amputation recovery?
The Axoguard Nerve Cap is unique because it uses a bioabsorbable material made from porcine small intestine submucosa to cap nerve endings, which helps prevent painful neuroma formation after amputation. This approach provides a physical barrier to protect nerves and creates a favorable environment for nerve healing, unlike traditional methods that may not address neuroma prevention as effectively.12467
What data supports the effectiveness of the treatment Axoguard Nerve Cap for amputation recovery?
The Axoguard nerve wrap, a component of the Axoguard Nerve Cap, has shown promising results in treating compression neuropathies, with no safety concerns reported. Additionally, in a case of lingual nerve injury, the use of an Axoguard nerve conduit led to improved sensation and taste, indicating its potential effectiveness in nerve repair.13678
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 who have had limb trauma or amputation and are scheduled for nerve surgery within 6-12 months, or need surgery to address nerve ends. Participants must have a terminated nerve end between 4-7 mm in diameter and be able to cover it with the Axoguard Nerve Cap. They should not be undergoing treatments affecting neural growth, have uncontrolled diabetes, infections, allergies to anesthetics, sensitivity to porcine products, or other conditions that would exclude them.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Implantation
Implantation of the Axoguard Nerve Cap® at the time of surgery
Post-operative Monitoring
Monitoring of adverse events and pain-related measures post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Axoguard Nerve Cap®
Axoguard Nerve Cap® is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Axogen Corporation
Lead Sponsor