Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03584022

Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

Peripheral Neuropathy Clinical Trial

Official title:
A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

Clinical Trial Summary

This is safety study. Subjects will be undergoing the surgical procedure of nerve biopsy. After routine surgery without grafting, patients develop swelling, redness, tenderness and dysesthesia at the biopsy site. In order to determine whether grafting is safe compared to not repairing the nerve, it is necessary to compare treated vs. untreated patients using systematic, sensitive and reproducible criteria.

Clinical Trial Description

Patients will be evaluated for eligibility and then, after gaining informed consent, the surgical procedure will be scheduled. Baseline evaluations include physical/neurological examination, nerve conduction study and ultrasonography of the sural nerve, and testing for erythrocyte sedimentation rate, C-reactive protein and complete blood counts (with white blood cell differential). Surgery is done in an operating room under local or monitored anesthesia, depending on patient preference. An incision will be made above the ankle. Immediately after the surgery, the patient will repeat the baseline physical/neurological exams, and sural nerve ultrasonography. Participants will be evaluated either in the clinic or by phone on a regular basis and will be required to keep a journal and fill out symptom questionnaires for up to 12 months post-procedure. Development of a grade 4 local reaction at any time will fulfill criteria for review by the Data and Safety Monitoring Board (DSMB) for implant removal and definition as a failure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03584022
Study type Interventional
Source Mayo Clinic
Contact
Status Active, not recruiting
Phase N/A
Start date November 9, 2018
Completion date March 2027
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Recruiting NCT05152368 - Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Trigeminal Neuralgia and Peripheral Neuropathy Phase 1
Completed NCT02549534 - Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer N/A
Active, not recruiting NCT02701075 - MC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain N/A
Completed NCT01196442 - Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer N/A
Completed NCT00763087 - Effect of Weight-Bearing Exercise on People With Diabetes and Neuropathic Feet N/A
Completed NCT00079807 - Painful HIV Neuropathy and Alpha-Lipoic Acid Phase 1/Phase 2
Completed NCT03292328 - Yoga for Symptoms of Nerve Damage Caused by Chemotherapy N/A
Active, not recruiting NCT05379140 - Use Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With HIV N/A
Recruiting NCT05673746 - Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer N/A
Completed NCT05189535 - "Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients" Phase 2/Phase 3
Recruiting NCT06219590 - Acetylcholine Iontophoresis As A New Challenge With Type 2 Diabetic Peripheral Neuropathy: A Possible New Therapy N/A
Enrolling by invitation NCT05595109 - Role of Silymarin in Chemotherapy Toxicity and Cognition Improvement in Breast Cancer Patients Phase 2/Phase 3
Completed NCT05916118 - Exercise and Oxaliplatin-induced Peripheral Neuropathy N/A
Withdrawn NCT03881748 - Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy N/A
Not yet recruiting NCT03112057 - Visualize Nociceptor Changes in Neuropathic Human N/A
Completed NCT02936843 - Targeting Inflammation With Salsalate in Type 1 Diabetes Neuropathy Phase 2/Phase 3
Terminated NCT01458015 - Tapentadol Versus Oxycodon - a Mechanism-based Treatment Approach in Neuropathic Pain Phase 4
Completed NCT01006408 - Treatment Trial Using Low Level Laser Therapy (LLLT) for Treatment of Chemotherapy Induced Peripheral Neuropathy N/A
Completed NCT00471445 - Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients Phase 3