15 Participants Needed

Axoguard Nerve Cap for Amputation Recovery

(REPOSE-XL℠ Trial)

Recruiting at 1 trial location
RA
RA
KI
IV
Overseen ByIan Valerio, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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

I have had an amputation and am having surgery to treat my nerve ends.
I am willing and able to follow the study's treatment and check-up schedule.
I have a nerve end between 4 and 7 mm wide after cleaning and stopping bleeding.
See 3 more

Exclusion Criteria

I am immunosuppressed or will be receiving immunosuppressive therapy.
I have diabetes with an HbA1c of 8% or higher, or diabetic neuropathy near my amputation site.
I experience numbness or pain in my hands/feet from past chemotherapy.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Surgery and Implantation

Implantation of the Axoguard Nerve Cap® at the time of surgery

1 day
1 visit (in-person)

Post-operative Monitoring

Monitoring of adverse events and pain-related measures post-surgery

15 months
Regular visits at 2 weeks, 1, 3, 6, 9, 12, and 15 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Axoguard Nerve Cap®
Trial Overview The study tests the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) on patients with limb trauma or amputations. It aims to protect and preserve terminated nerve endings when immediate repair isn't possible. The feasibility and tolerability of this device will be evaluated over time.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Axoguard Nerve Cap®Experimental Treatment1 Intervention

Axoguard Nerve Cap® is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Axoguard Nerve Cap for:
🇪🇺
Approved in European Union as Axoguard Nerve Cap for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Axogen Corporation

Lead Sponsor

Trials
11
Recruited
5,600+

Published Research Related to This Trial

AxoGuard nerve wrap, used in conjunction with neurolysis and tenosynovectomy, has previously shown no safety concerns in treating recurrent carpal and ulnar tunnel syndrome, but a case of necrotic granulomatous inflammation was reported 2.5 months after its application.
As a salvage treatment, a NuShield placental allograft was successfully used around the median nerve, indicating that placental allografts may be effective for patients with compression neuropathy who do not respond to other surgical interventions.
Necrotic Granulomatous Inflammation after Use of Small Intestine Submucosa Matrix for Recurrent Compression Neuropathy.Koenig, ZA., Burns, JC., Hayes, JD.[2022]
A novel technique using Tisseel fibrin glue to stabilize an Axoguard nerve conduit during lingual nerve injury repair resulted in successful recovery with fewer sutures needed.
Five months after the surgery, the patient reported improved sensation and taste, and neurosensory examination confirmed functional recovery, indicating the technique's efficacy in nerve repair.
Use of Fibrin Glue as an Adjunct in the Repair of Lingual Nerve Injury: Case Report.Theberge, NP., Ziccardi, VB.[2017]
In a study involving 91 rats, using a closed-end bioabsorbable nerve conduit significantly reduced neuropathic pain compared to no capping, indicating its efficacy in preventing painful amputation neuromas.
Both open and closed-end conduits prevented the formation of neuromas and reduced neuroinflammation, but the closed-end version was more effective in blocking scar formation and protecting the nerve stump.
Nerve capping treatment using a bioabsorbable nerve conduit with open or closed end for rat sciatic neuroma.Hama, S., Uemura, T., Onode, E., et al.[2022]

Citations

Necrotic Granulomatous Inflammation after Use of Small Intestine Submucosa Matrix for Recurrent Compression Neuropathy. [2022]
Use of Fibrin Glue as an Adjunct in the Repair of Lingual Nerve Injury: Case Report. [2017]
Nerve capping treatment using a bioabsorbable nerve conduit with open or closed end for rat sciatic neuroma. [2022]
Interdigital direct neurorrhaphy for treatment of painful neuroma due to finger amputation. [2022]
Lingual Nerve Microsurgery Outcomes Using 2 Different Conduits: A Retrospective Cohort Study. [2017]
A Comparative Study of Porcine Small Intestine Submucosa and Cross-Linked Bovine Type I Collagen as a Nerve Conduit. [2022]
Painful Terminal Neuroma Prevention by Capping PRGD/PDLLA Conduit in Rat Sciatic Nerves. [2023]
The prevention and treatment of amputation neuromata by silicone capping. [2022]
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