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Nerve Protection Device

Axoguard Nerve Cap for Amputation Recovery (REPOSE-XL℠ Trial)

N/A

Recruiting

Research Sponsored by Axogen Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Present for surgery with a previous amputation and be undergoing surgery to address nerve ends

Be an adult male or female ≥ 18 and ≤ 80 years of age

Must not have

Be immunosuppressed or have planned immunosuppressive therapy during the duration of the study

Have signs and symptoms of chemotherapy-induced peripheral neuropathy from previous chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2, 1, 3, 6, 9, 12, and 15 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether a device called the Axoguard Large-Diameter Nerve Cap can help preserve nerve endings after limb trauma or amputation when immediate medical attention is not possible.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for this pilot study, potential risks may include local irritation at the cap site, allergic reactions if sensitive to porcine-derived materials used in the cap, infection risk due to implantation of a foreign body, and general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had an amputation and am having surgery to treat my nerve ends.

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I am between 18 and 80 years old.

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I have enough soft tissue for proper coverage by the Axoguard Nerve Cap.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am immunosuppressed or will be receiving immunosuppressive therapy.

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I experience numbness or pain in my hands/feet from past chemotherapy.

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I have a bone growth in my limb where the nerve cap will be placed that hasn't been treated.

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I cannot have implants due to conditions affecting blood supply or healing.

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I have a history of unexplained nerve pain, sciatica, or chronic back pain.

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I have diabetes with an HbA1c of 8% or higher, or diabetic neuropathy near my amputation site.

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I am currently receiving or will receive treatment that affects nerve or blood vessel growth.

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I have had or will have radiotherapy on the end-neuroma area.

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I have nerve pain in my limb that didn't improve with a specific nerve pain treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2, 1, 3, 6, 9, 12, and 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2, 1, 3, 6, 9, 12, and 15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, 1, 3, 6, 9, 12, and 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety: Adverse Events (AEs), Serious Adverse Events (SAEs), or Unanticipated Adverse Device Effects (UADEs)

Secondary study objectives

Amputation

Change in Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures through TMR or RPNI procedure or 12 post operative months compared to baseline

Change in Timed Up and Go (TUG) Test for Lower Extremity Amputees through 12 post-operative months compared to baseline

+4 more

Other study objectives

Histological Assessment of Explanted Nerve Cap After Secondary Procedure

Nerve End Size Measurements

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Axoguard Nerve Cap®Experimental Treatment1 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

0 / 12Eligibility criteria met