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Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain | Clinical Trials | Clareo Health

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Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain

A Multicenter, Prospective, Randomized and Subject Blinded Comparative Study of AxoGuard® Nerve Cap and Neurectomy for the Treatment of Symptomatic Neuroma and Prevention of Recurrent End-Neuroma Pain

NCT03940963•Axogen Corporation

View on ClinicalTrials.gov

Summary

Comparing safety, pain, user experience, healthcare economic costs, work productivity, impairment and quality of life outcomes between Axoguard® Nerve Cap and neurectomy in the treatment of symptomatic neuromas in the foot or ankle. Study consists of 86 subjects randomized between the treatment groups followed for 12 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be able and willing to provide documented informed consent prior to the conduct of any study procedures;
•2. Be an adult male or non-pregnant female ≥ 18 years of age;
•3. Report baseline pain scores of \>65mm on a 100mm Visual Analog Scale (VAS) at screening;
•4. Have a documented diagnosis of symptomatic neuroma of at least one interdigital nerve in the foot which cannot be repaired to a distal nerve end;
•5. Must have the of the following:
•* Pain with at least 3 of the following characteristics: burning, sharp, shooting, electric, parasthesias, numbness, cold intolerance;
•* Symptoms in a defined neural anatomic distribution
•* History of nerve injury or suspected nerve injury
•Must have at least 1:
•* Positive response to local anesthetic injection
+5 more criteria

Exclusion Criteria

•1. Have undergone surgical treatment of pain from symptomatic neuroma in the target nerve(s)on three or more occasions;
•2. Have biomechanical pathology and associated pain (such as plantar fasciitis, bursitis, sesamoid bone pain, tendinitis, etc);
•3. Have a life expectancy of less than 12 months;
•4. Have a history of or planned radiotherapy in the area of the end-neuroma;
•5. be contraindicated for soft tissue implants.; this includes but is not limited to any pathology that would limit the blood supply; compromise healing or indicate the presence of a local infection;
•6. Have a history of chronic ischemic conditions of the extremity;
•7. Have a diagnosis of type 1 Diabetes Mellitus; or uncontrolled Type 2 Diabetes Mellitus (at the discretion of the investigator);
•8. Have a history of diabetic neuropathy;
•9. Be undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of neural and/or vascular system;
•10. Be immunosuppressed, immunocompromised or have planned immunosuppressive therapy within 12 months following the study procedure;
+8 more criteria

Locations (11)

New Hope Podiatry Group

Los Angeles, California, United States

Anastasia Medical Group

Saint Augustine, Florida, United States

EHI Clinical Research

Roswell, Georgia, United States

Gateway Clinical Trials

O'Fallon, Illinois, United States

OrthoIllinois

Rockford, Illinois, United States

Foot and Ankle Center of Illinois

Springfield, Illinois, United States

The Ohio State University

Columbus, Ohio, United States

Austin Foot and Ankle Specialists

Austin, Texas, United States

Complete Foot and Ankle Care of North Texas

Denton, Texas, United States

JPS Health Network

Fort Worth, Texas, United States

Key Dates

Start Date

October 10, 2018

Primary Completion Date

July 17, 2023

Completion Date

July 17, 2023

Last Updated

January 9, 2025

Enrollment

ACTUAL participants

Conditions

Symptomatic NeuromaMorton's NeuromaChronic Nerve Pain

Interventions

AxoGuard® Nerve Cap

DEVICE

Standard Neurectomy

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain

Inclusion Criteria

Exclusion Criteria

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