Axoguard Nerve Cap for Amputation Recovery

(REPOSE-XL℠ Trial)

Not currently recruiting at 1 trial location

Overseen By Ian Valerio, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Axogen Corporation

Must not be taking: Chemotherapy, Radiation, Immunosuppressants, others

Disqualifiers: Infection, Diabetes, Neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called the Axoguard Nerve Cap, designed to assist individuals who have undergone limb amputation or experienced serious limb trauma. The treatment focuses on protecting nerve ends when immediate surgery isn't possible, aiming to ease recovery and reduce nerve pain. It suits those planning secondary nerve surgery, such as Targeted Muscle Reinnervation, or undergoing surgery to manage nerve ends after an amputation. Participants should have a nerve end size between 4 and 7 mm and sufficient soft tissue for secure placement of the nerve cap. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatments for nerve pain.

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.

What prior data suggests that the Axoguard Nerve Cap is safe for amputation recovery?

Research has shown that the Axoguard Nerve Cap is generally well-tolerated. In studies, patients using the Axoguard Nerve Cap reported less pain compared to those receiving standard care. This suggests that the device not only reduces pain but is also safe to use. Additional studies focusing on safety, pain levels, and quality of life have found similar positive results, supporting its tolerability.

The Axoguard Nerve Cap, made from a material derived from pigs, is designed to protect nerve endings after an injury or amputation. It is important to note that this nerve cap has been tested in various situations and has shown positive results in reducing pain and preserving nerve function.

Overall, existing evidence supports the Axoguard Nerve Cap as a safe treatment option for managing nerve injuries after limb trauma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for amputation recovery that often focus on pain management and basic wound care, the Axoguard Nerve Cap® offers an innovative approach by targeting nerve endings directly. This treatment uses a porcine-derived extracellular matrix to envelop the nerve stumps, which can potentially reduce painful neuroma formation. Researchers are excited because this method could improve healing outcomes and enhance quality of life for amputees by addressing nerve issues at the source, rather than just managing symptoms.

What evidence suggests that the Axoguard Nerve Cap is effective for amputation recovery?

Studies have shown that the Axoguard Nerve Cap, which participants in this trial will receive, helps reduce pain for individuals with nerve injuries, such as those following an amputation. In earlier research, this device proved more effective at lowering pain than the usual treatment, which involves surgery to remove part of a nerve. The Axoguard Nerve Cap covers and protects nerve ends, preventing painful nerve scars. Users of this nerve cap reported less pain and an improved quality of life. Overall, the Axoguard Nerve Cap has shown promising results in aiding recovery from nerve damage with reduced pain. ^{1 2 3 6 7}

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.

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.

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?

Group I: Axoguard Nerve Cap® Experimental Treatment 1 Intervention

Active Comparator: Porcine derived extracellular matrix (ECM) based Nerve Termination Device Implantation of appropriate diameter of Axoguard Nerve Cap® (sizes 5-7 mm) at the time of surgery

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

Approved in United States as Axoguard Nerve Cap for:

• Protection of peripheral nerve ends to reduce symptomatic or painful neuroma development

Approved in European Union as Axoguard Nerve Cap for:

• Protection of peripheral nerve ends to reduce symptomatic or painful neuroma development

Who Is Running the Clinical Trial?

Axogen Corporation

Lead Sponsor

Trials

11

Recruited

5,600+

Published Research Related to This Trial

In a study involving 10 rabbits, silicone capping of amputated nerves effectively prevented neuroma formation when the cap's length-to-diameter ratio was maintained between 5:1 and 10:1, indicating a specific design is crucial for success.

In a clinical trial with 18 patients suffering from traumatic neuromas, 15 patients experienced relief from pain after silicone capping, although some required revision surgery, highlighting the treatment's potential effectiveness but also the need for careful monitoring and follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevention and treatment of amputation neuromata by silicone capping. Swanson, AB., Boeve, NR., Lumsden, RM.[2022]

In a study involving 18 male Lewis rats, the Axoguard Nerve Connector (SIS) promoted a favorable macrophage type 2 (M2) response, which is associated with tissue healing and regeneration, compared to the NeuraGen Nerve Guide (Col) that showed a dominant macrophage type 1 (M1) response linked to inflammation.

The SIS conduits demonstrated better vascularization and fibroblast ingrowth, while the Col conduits formed a capsule-like structure, indicating that the choice of biomaterial significantly influences the host tissue response and could affect clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Study of Porcine Small Intestine Submucosa and Cross-Linked Bovine Type I Collagen as a Nerve Conduit. Zhukauskas, R., Fischer, DN., Deister, C., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Fibrin Glue as an Adjunct in the Repair of Lingual Nerve Injury: Case Report. Theberge, NP., Ziccardi, VB.[2017]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Necrotic Granulomatous Inflammation after Use of Small Intestine Submucosa Matrix for Recurrent Compression Neuropathy. Koenig, ZA., Burns, JC., Hayes, JD.[2022]

The study evaluated a new biocompatible nerve conduit made from PRGD/PDLLA, which significantly reduced neuropathic pain and improved recovery in rats after sciatic nerve amputation, as indicated by lower autotomy scores and better tissue structure.

The PRGD/PDLLA conduits not only prevented inflammatory infiltration and excessive collagen deposition but also promoted proper myelination and nerve repair, suggesting they could be an effective solution to prevent neuroma formation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Painful Terminal Neuroma Prevention by Capping PRGD/PDLLA Conduit in Rat Sciatic Nerves. Yi, J., Jiang, N., Li, B., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a retrospective study of seven patients, interdigital neurorrhaphy after neuroma resection showed significant improvements in pain and upper limb functionality, with mean improvements of 29.8% on the Visual Analog Scale (VAS) and 55.5% on the Disabilities of the Arm, Shoulder and Hand (DASH) score over an average follow-up of 28.3 months.

No long-term complications were reported, suggesting that interdigital neurorrhaphy is a safe and feasible surgical option for treating painful digital neuroma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interdigital direct neurorrhaphy for treatment of painful neuroma due to finger amputation. Martins, RS., Siqueira, MG., Heise, CO., et al.[2022]

In a study comparing two types of nerve conduits (NeuraGen and AxoGuard) used in lingual nerve microsurgery, both conduits resulted in similar improvements in sensory recovery, indicating their comparable efficacy.

All patients achieved functional sensory recovery (FSR) as per the Medical Research Council Scale, with no significant differences in outcomes between the two conduits, suggesting both are effective options for nerve repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lingual Nerve Microsurgery Outcomes Using 2 Different Conduits: A Retrospective Cohort Study. Wilson, MT., Chuang, SK., Ziccardi, VB.[2017]

Citations

1. ir.axogeninc.com ir.axogeninc.com/press-releases/detail/974/axogen-inc-announces-positive-topline-results-from

Axogen, Inc. Announces Positive Topline Results from ... Axoguard Nerve Cap demonstrated statistical superiority vs. standard-of-care neurectomy in the reduction of total pain reported by participants over the course ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03940963

NCT03940963 | Study of AxoGuard® Nerve Cap and ... Comparing safety, pain, user experience, healthcare economic costs, work productivity, impairment and quality of life outcomes between Axoguard® Nerve Cap ...

3. clinicaltrial.be clinicaltrial.be/en/details/44542?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Tolerability and Feasibility Pilot Clinical Study of a La... This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and ...

4. axogeninc.com axogeninc.com/clinical-data/

comparability of allograft vs. autograft nerve repair A prospective randomized controlled study to assess the impact of Axoguard Nerve Cap® in the management of painful neuroma as compared to standard neurectomy.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04865679/tolerability-and-feasibility-pilot-clinical-study-of-a-large-diameter-nerve-cap-for-protecting-and-preserving-terminated-nerve-ends

Tolerability and Feasibility Pilot Clinical Study of a Large ... This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and ...

6. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1199701.pdf

Tolerability and Feasibility Pilot Clinical Study of a Large ... The primary objective of this study is to evaluate Axoguard Nerve Cap in large diameter sizes (5mm - 7mm) for protecting and preserving terminated large ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10473362/

The Use of Nerve Caps after Nerve Transection in ... At 1-year follow-up, subjective outcomes and Migraine Headache Index scores were tabulated. Results: Two patients underwent nerve capping as a ...