tolerability and feasibility pilot clinical study of a large-diameter nerve cap for protecting and preserving terminated nerve ends

Conditions: Symptomatic Neuroma; Amputation; Chronic Nerve Pain

Summary: 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.


Eligibility criteria:
inclusion criteria: potential subjects must: 1. sign and date an irb-approved written informed consent form prior to initiation of any study procedures; 2. be an adult male or female ≥ 18 and ≤ 80 years of age; 3. present for surgery with either: 1. limb trauma and/or planned amputation of a limb and be candidates who are planned for a secondary nerve surgery such as targeted muscle reinnervation (tmr) or regenerative peripheral nerve interface (rpni) procedures within 6-12 months from time of amputation, or; 2. a previous amputation and be undergoing surgery to address nerve ends; 4. have at least one nerve end measuring greater than 4 mm and less than 7 mm in diameter after debridement and hemostasis of the proximal nerve stump; 5. have sufficient soft tissue available to be adequately covered by the axoguard nerve cap; 6. be willing and able to comply with all aspects of the treatment and follow-up assessments and to return for all required study visits throughout the study duration. exclusion criteria: potential subjects must not: 1. currently undergoing or are expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment that affects the growth of neural and/or vascular tissues; 2. have signs and symptoms of chemotherapy-induced peripheral neuropathy from previous chemotherapy; 3. be immunosuppressed or have planned immunosuppressive therapy during the duration of the study; 4. current uncontrolled local or systemic infection as indicated by positive blood culture or other pathological indicators of infection; 5. be contraindicated for soft tissue implants. this includes but is not limited to any pathology that would limit the blood supply to the target area or otherwise compromise healing; 6. have a life expectancy of less than 15-months; 7. have a history of or be planning to undergo radiotherapy in the area of the end-neuroma; 8. have bony exostosis of the affected limb that is not treated at the time of nerve cap placement; 9. have uncontrolled type 1 or type 2 diabetes mellitus with hba1c of 8% or greater or those with diabetic neuropathy in the target area or proximal to the amputation site; 10. have a history of idiopathic neuropathy/radiculopathy, known sciatica or chronic back pain; 11. documented history of centralized nerve pain that does not respond to a peripheral nerve block in the affected limb; 12. have a known allergy to anesthetic agents; 13. have a known sensitivity to porcine-derived products; 14. be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or 15. be deemed unsuitable for inclusion in the study at the discretion of the investigator.

Keywords: peripheral nerve injuries peripheral nervous system disease neuroma nerve pain nervous system diseases trauma - nervous system amputation nerve repair surgical treatment of pain