Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
Running, not enrolling · Not applicable
Conditions studied: Peripheral Neuropathy, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Vasculitic Neuropathy (Disorder), Amyloidosis, Hereditary Neuropathy, Sarcoid Neuropathy
In brief
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.
Key facts
- Study ID
- NCT03584022
- Run by
- Mayo Clinic
- People needed
- 20
- Starts
- 2018-11-09
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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