High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: A Prospective Registry (NCT07360730) | Clinical Trial Compass
CompletedNot Applicable
High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: A Prospective Registry
India40 participantsStarted 2025-12-09
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 to 70 years
* Patients undergoing peripheral nerve procedures including: Primary nerve repair, Nerve coaptation, Nerve grafting, Nerve transfer, Revision nerve decompression
* Upper or lower limb nerve involvement
* Intraoperative use of HPTC nerve wrap
* Ability to comply with follow-up
* Written informed consent provided
Exclusion Criteria:
* Active infection at the surgical site
* Known hypersensitivity to collagen products
* Severe uncontrolled systemic illness
* Pregnancy or lactation
* Re-operation at the same nerve site within the previous 6 months
* Inability to provide informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Motor Functional Recovery (MRC Grade ≥ M3)
Timeframe: 2 months post-operative
2
Sensory Recovery - Two-Point Discrimination
Timeframe: 2 months post-operative
3
Number of Participants With Sensory Recovery Assessed by Semmes-Weinstein Monofilament Testing
Timeframe: 2 months post-operative
Trial details
NCT IDNCT07360730
SponsorAdichunchanagiri Institute of Medical Sciences, B G Nagara