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Peripheral Nerve InjuriesNCT07360730

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

A study testing High-Purity Type I Collagen (HPTC) Nerve Wrap in people with Peripheral Nerve Injuries and Neuroma of Nerve Repair, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 2 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
High-Purity Type I Collagen (HPTC) Nerve Wrap
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesIndia
Study dates
9 Dec 2025to 3 Mar 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

India2 sites
  • Adichunchanagiri Institute of Medical Sciences

    Mandya, Karnataka, 571448

  • Mysore Medical College and Research Institute

    Mysore, Karnataka, 570001

Other trials in India

About this study

Official title: Prospective Multicentre Registry of High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: Early Clinical Outcomes

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.

Read the detailed description

Peripheral nerve surgery outcomes are often compromised by perineural fibrosis, neuroma formation, and unpredictable axonal regeneration. High-Purity Type I Collagen (HPTC) is a bioengineered resorbable collagen membrane designed to act as a biologic scaffold and perineural barrier, potentially reducing scar adherence and facilitating nerve gliding.

This prospective registry enrolls adult patients undergoing peripheral nerve procedures where HPTC is used as an adjunct circumferential nerve wrap. Functional motor recovery, sensory recovery, pain scores, patient-reported outcomes, and complications will be systematically documented at baseline and follow-up intervals up to four months. This registry aims to generate real-world, multicentre evidence regarding the safety and early clinical effectiveness of HPTC nerve wrapping.

Being tested
High-Purity Type I Collagen (HPTC) Nerve Wrap
Medical subject headings
Peripheral Nerve Injuries, Neuroma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Purity Type I Collagen (HPTC) Nerve WrapDevice

    After completion of nerve repair, coaptation, grafting, transfer, or decompression, a sterile HPTC collagen membrane is hydrated as per manufacturer instructions, trimmed to the length of the treated nerve segment (approximately 1.5-4 cm), and wrapped circumferentially as a loose perineural sleeve. The wrap is secured using fibrin glue or fine absorbable sutures. Standard wound closure and postoperative rehabilitation protocols are followed.

Study groups in NCT07360730
Study groupRoleWhat they receive
HPTC Nerve Wrap ArmExperimentalParticipants undergoing peripheral nerve procedures-including nerve repair, coaptation, grafting, nerve transfer, or decompression-in whom a High-Purity Type I Collagen (HPTC) membrane is used intraoperatively as a circumferential nerve wrap. Outcomes related to motor recovery, sensory recovery, neuropathic pain, complications, and patient-reported functional status are prospectively assessed.
Receives: Device: High-Purity Type I Collagen (HPTC) Nerve Wrap

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Motor Functional Recovery (MRC Grade ≥ M3)

    Motor recovery of the involved muscle groups assessed using the Medical Research Council (MRC) Motor Grading system. Successful recovery was defined as achievement of MRC grade ≥ M3, representing active movement against gravity.

    Measured: 2 months post-operative

  2. Sensory Recovery - Two-Point Discrimination

    Sensory recovery assessed using two-point discrimination testing in the affected nerve distribution, measured as the minimum distance (in millimeters) at which two points are perceived as separate.

    Measured: 2 months post-operative

  3. Number of Participants With Sensory Recovery Assessed by Semmes-Weinstein Monofilament Testing

    Number of participants demonstrating sensory recovery as assessed by Semmes-Weinstein monofilament testing at 2 months postoperatively. Sensory recovery was defined as the ability to perceive a clinically meaningful monofilament threshold in the affected nerve distribution. Higher values indicate greater proportion of participants achieving sensory recovery.

    Measured: 2 months post-operative

Secondary outcomes (4)
  1. Neuropathic Pain Intensity

    Neuropathic pain intensity measured using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents worst imaginable pain.

    Measured: Baseline, 1 month, and 2 months post-operative

  2. Upper Limb Patient-Reported Functional Outcome (QuickDASH)

    Upper limb function assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. The QuickDASH consists of 11 items scored on a scale from 0 to 100, where 0 represents no disability and 100 represents maximum disability. Higher scores indicate worse functional outcome.

    Measured: 1 month and 2 months post-operative

  3. Lower Limb Patient-Reported Functional Outcome (LEFS)

    Lower limb function assessed using the Lower Extremity Functional Scale (LEFS). The LEFS consists of 20 items with a total score ranging from 0 to 80, where higher scores indicate better functional outcome.

    Measured: 1 month and 2 months post-operative

  4. Patient Satisfaction

    Patient satisfaction assessed using a 5-point Likert Satisfaction Scale, with scores ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater patient satisfaction.

    Measured: 2 months post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start9 Dec 2025
  3. Primary completion26 Feb 2026
  4. Study completion3 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07360730
Sponsor's protocol ID
AIMS/IEC/269/2025
Status last verified
Mar 2026
First submitted
2 Jan 2026
Last updated
30 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported for the primary and secondary outcomes of this study, including motor recovery scores (MRC grading), sensory assessment results, pain scores (VAS), patient-reported outcome measures (QuickDASH/LEFS), complication data, and relevant baseline demographic and procedural variables.

Publications

  • Klein S, Vykoukal J, Felthaus O, Dienstknecht T, Prantl L. Collagen Type I Conduits for the Regeneration of Nerve Defects. Materials (Basel). 2016 Mar 23;9(4):219. doi: 10.3390/ma9040219.

    PubMed 28773346
  • Kokkalis ZT, Mavrogenis AF, Ballas EG, Papagelopoulos PJ, Soucacos PN. Collagen nerve wrap for median nerve scarring. Orthopedics. 2015 Feb;38(2):117-21. doi: 10.3928/01477447-20150204-04.

    PubMed 25665110
  • Tanaka H, Kurimoto S, Hirata H. Efficacy of collagen conduit wrapping with collagen fibers on nerve regeneration in sciatic nerve injury with partial transection: An experimental study in the rat model. J Biomed Mater Res B Appl Biomater. 2024 Jan;112(1):e35369. doi: 10.1002/jbm.b.35369.

    PubMed 38247253
  • Narayan N, Shivannaiah C, Gowda S. Evaluating the Efficacy of High-Purity Type I Collagen-Based Skin Substitute Versus Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers: A Randomized Controlled Clinical Trial. Cureus. 2025 Jul 30;17(7):e89031. doi: 10.7759/cureus.89031. eCollection 2025 Jul.

    PubMed 40747200
  • Narayan N, Ramegowda YH, Raghupathi DS, Chethan S, Gowda S. Biological Skin Substitutes in Pressure Ulcers: High-Purity Type I Collagen-Based Versus Amnion/Chorion Membrane. Cureus. 2025 Aug 25;17(8):e90956. doi: 10.7759/cureus.90956. eCollection 2025 Aug.

    PubMed 40862036
  • Narayan N, Shivaiah R, Kumar V, Kumar KM, Chethan S, Gowda S. Comparative Efficacy of High Purity Type I Collagen-Based Skin Substitute and Dehydrated Human Amnion/Chorion Membrane in Diabetic Foot Ulcers: A Multicentre Randomized Controlled Trial. Cureus. 2025 Oct 19;17(10):e94952. doi: 10.7759/cureus.94952. eCollection 2025 Oct.

    PubMed 41122365
  • Narayan N, Raghupathi D, Ramamurthy V, Chethan S, Gowda S. A Comparative Analysis in the Treatment of Full-Thickness Wounds: Negative-Pressure Wound Therapy (NPWT) Combined With High-Purity Type I Collagen-Based Skin Substitute Versus NPWT Alone. Cureus. 2025 Nov 16;17(11):e96977. doi: 10.7759/cureus.96977. eCollection 2025 Nov.

    PubMed 41250786
  • Lee S, Ahmad A, Jeon G. Combining Bootstrap Aggregation with Support Vector Regression for Small Blood Pressure Measurement. J Med Syst. 2018 Feb 28;42(4):63. doi: 10.1007/s10916-018-0913-x.

    PubMed 29488105
  • Mayrhofer-Schmid M, Klemm TT, Aman M, Kneser U, Eberlin KR, Harhaus L, Boecker AH. Shielding the Nerve: A Systematic Review of Nerve Wrapping to Prevent Adhesions in the Rat Sciatic Nerve Model. J Pers Med. 2023 Sep 24;13(10):1431. doi: 10.3390/jpm13101431.

    PubMed 37888042
  • Radecka W, Nogalska W, Siemionow M. Peripheral Nerve Protection Strategies: Recent Advances and Potential Clinical Applications. J Funct Biomater. 2025 Apr 24;16(5):153. doi: 10.3390/jfb16050153.

    PubMed 40422818

Questions about this trial

What is this clinical trial studying?

A study testing High-Purity Type I Collagen (HPTC) Nerve Wrap in people with Peripheral Nerve Injuries and Neuroma of Nerve Repair, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 2 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motor Functional Recovery (MRC Grade ≥ M3) (time frame: 2 months post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07360730, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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