Clinical Trial

High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: A Prospective Registry

Completed
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Summary
This prospective multicentre observational registry evaluates early clinical outcomes following the use of High-Purity Type I Collagen (HPTC) as a circumferential nerve wrap during peripheral nerve procedures. Eligible procedures include nerve repair, coaptation, grafting, nerve transfers, and decompressions in the upper and lower limbs. Primary outcomes include early motor recovery assessed using the Medical Research Council (MRC) motor grading system. Secondary outcomes include sensory recovery, neuropathic pain, patient-reported functional outcomes, complication rates, and patient satisfaction assessed at standardized postoperative intervals up to two months.
Protocol Amendment History 2 changes
critical Trial completed 2026-03-31
critical Primary endpoint(s) modified 2026-03-31
Trial Details
NCT Number NCT07360730
Lead Sponsor Adichunchanagiri Institute of Medical Sciences, B G Nagara
Collaborators: Mysore Medical College and Research Institute
Conditions Peripheral Nerve Injuries, Neuroma of Nerve Repair, Nerve Graft; Complications, Mechanical, Peripheral Nerve Decompression Injury, Neuroma
Enrollment 40 participants
Start Date 2025-12-09
Primary Completion 2026-02-26 (estimated)
Study Completion 2026-03-03 (estimated)
Updated on ClinicalTrials.gov 2026-03-30