Phase 4 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are 18 years of age or older at the time of signing the consent form
• People who are willing and able to attend all required appointments and follow the study schedule for 24 months
• People who have signed an ethics-approved consent form before any study procedures begin
• People who have had a completely severed nerve in the arm repaired using either a donor nerve graft taken from the leg (sural nerve autograft) or a processed nerve graft product called Avance Nerve Graft — for specific nerves in the forearm and elbow region (confirm with trial site for exact nerve locations)
• People where the damaged section of the nerve could be fully removed, leaving healthy nerve tissue on both ends, within the arm regions specified by the trial
• People with more than one eligible nerve injury who had all eligible nerves repaired using the same type of graft (either all Avance or all sural nerve — not a mix of both)
• People where the gap in the nerve after the damaged section was removed measured more than 25 mm
• People whose nerve repair was performed within 120 days (about 4 months) of the original injury
• People whose nerve repair involved the surgeon connecting both the top and bottom ends of the nerve gap following the standard methods for each graft type
• People for whom both graft options (Avance Nerve Graft or sural nerve autograft) were medically suitable choices for all nerve repairs involved

Who may not be able to join:

• People currently taking part in another clinical study that could interfere with this trial's treatments or assessments
• People with existing deformities or injuries to the arm, hand, or fingers that would affect the trial's ability to measure results
• People with a history of any nerve disease or nerve damage affecting the injured arm, including diabetic nerve disease or nerve damage from compression or trauma
• People with a history of a progressive nerve or autoimmune condition affecting nerves or movement, such as ALS, multiple sclerosis, or Parkinson's disease
• People with a history of long-term poor blood supply (chronic ischemia) in the upper arm or hand
• People who are expected to take medications during the study that are known to interfere with nerve healing or cause nerve damage
• People who are receiving or expected to receive chemotherapy, radiation therapy, or other treatments known to affect nerve or blood vessel growth
• People who are unlikely to follow all study requirements and standard medical care for the full duration of the study
• People with a median nerve repair where the ulnar nerve was also fully cut due to injury or surgery
• People whose repair involves a nerve stump at the upper end that carries only sensory (feeling) signals, not motor (movement) signals
• People with a partial nerve cut — only fully severed nerves are eligible
• People with nerve damage at two or more separate points along the same nerve pathway requiring more than one reconstruction along that nerve
• People with insufficient skin or tissue coverage over the repair area, or extensive surrounding tissue damage, that would prevent proper recovery assessment
• People whose nerve was torn away from its attachment point (avulsion) or stretched until it ruptured (traction injury)
• People who had a limb, hand, or finger reattached after amputation, where that limb or digit is involved in the trial's key assessments
• People whose nerve repair used a side-to-side or end-to-side joining technique (confirm with trial site for terminology)
• People who had a nerve transfer, tendon transfer, or other procedure at the time of nerve repair that would affect the ability to measure muscle function
• People whose repair used joining devices containing metal components or activated polymers, or where the nerve ends were joined using only fibrin glue
• People with vascular (blood vessel) damage that resulted in inadequate blood flow to the area even after repair — specifically, people where both the radial and ulnar arteries were injured (one injured artery is permitted)

Important: Always verify eligibility with the trial site directly before applying.