Peripheral Neuropathy Clinical Trial
Official title:
A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
Verified date | April 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | March 2027 |
Est. primary completion date | March 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria - Are between the ages of 18-75 years - Have clinical indications for whole sural nerve biopsy - Have a sural nerve SNAP with amplitude > or = 2 microvolt (µV) - Are able to comply with protocol requirements - Can provide written informed consent - Willingness to complete study procedures Exclusion Criteria - Current smoker. - History of prior musculoskeletal (joint or soft tissue) infection. - Pre-operative nares culture positive for methicillin-resistant Staphylococcus Aureus (MRSA) or methicillin-sensitive Staphylococcus Aureus (MSSA) - Have systemic immune disorders, such as Crohn's Disease, rheumatoid arthritis, or psoriasis with the exception of hyper/hypothyroidism. - Have diabetes mellitus. - Have previous trauma to the biopsy site. - Have any major, clinically significant medical condition (e.g., within six months of baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure) that, in the opinion of the investigator, would compromise the safety of patient. - Are pregnant or breast-feeding. - Unwilling to use adequate contraception. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety as determined by number of participants with post-surgical reactions | Post-surgical reactions will include evaluations of the following:
Percussion tenderness at site of proximal stump or repair site; Skin redness at the site of biopsy (length and width measured with calipers); Development of mild or moderate swelling along the site (yes or no). It is anticipated that this will resolve to a lower grade or progress to grade 4. Development of severe swelling or pustules or evidence of tube extrusion or wound dehiscence. |
up to 5 years post surgery | |
Secondary | Neuropathic pain as measured by SNAP | Sensory nerve action potential (SNAP) will be measured at the ankle using small electric shocks and recording pads on the skin. This will be done by an experienced and board-certified electrophysiologist. | 3 months & 12 months | |
Secondary | Neuropathic pain as measured by visual analogue pain scale | The Visual Analogue Scale (VAS) consists of a straight line with the endpoints of 'No pain' and 'Pain as bad as it could possibly be'. The subject is asked to mark his or her pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark defines the subject's pain. | weekly, monthly for first 3 months, then 12 months and yearly for 4 years | |
Secondary | Neuropathic pain as measured by visual analogue pain assessment questionnaire | Subjects will be asked to check all of the following that apply: 1) fever, 2) unexplained or new joint aches and pain, 3) increased skin redness at or near the site of the biopsy, 4) increased swelling at or near the site of the biopsy, 5) some degree of pain or discomfort at or near the site of the biopsy | weekly, monthly for first 3 months, then 12 months and yearly for 4 years | |
Secondary | Neuroma formation | Non-invasive nerve ultrasound will be performed to determine neuroma formation | 3 months & 12 months | |
Secondary | Sensory nerve regeneration as measured by SNAP | The amplitude of sensory nerve action potential (SNAP) will be used to determine sensory nerve regeneration | 3 months & 12 months | |
Secondary | Sensory nerve regeneration as measured by ultrasound | Non-invasive nerve ultrasound will be performed to determine sensory nerve regeneration | 3 months & 12 months |
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