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NCT07285486 · ClinicalTrials.gov registry record
Regenerative Peripheral Nerve Interfaces for the Treatment of Painful Neuromas in Major Limb Amputees
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 132
- Enrollment target
NCT07285486 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 132 participants.
The verdict
NCT07285486 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 132 participants
- Enrollment target
Study Summary
The Regenerative Peripheral Nerve Interface (RPNI) is a novel strategy to prevent neuroma formation in transected peripheral nerves. The RPNI consists of a residual peripheral nerve that is implanted into a free skeletal muscle graft either at the time of limb amputation or after excision of a terminal neuroma bulb. The sprouting axons of the nerve readily reinnervate the free muscle graft, thereby greatly reducing the chance of neuroma formation. This investigation has a prospective cohort study design involving major lower limb amputees drawn from both the University of Michigan Health Systems and VA Health System of Ann Arbor. To objectively evaluate the effect of RPNI surgery on patients' perception of pain and to measure other health-related quality of life metrics relating to neuroma pain, this clinical trial will utilize specific, validated patient-reported outcomes measures (PROMs) to assess targeted domains in patients with major limb amputation. These survey instruments will determine: 1) patterns of pain medication use, including the use of opioids, 2) functional status and use of a prosthetic device, 3) changes in neuroma pain quality, 4) limitations in activities of daily living due to neuroma pain, 5) depression and anxiety relating to neuroma pain.
Interventions
- PROCEDURE Amputation with Regenerative Peripheral Nerve Interfaces (RPNI)
- OTHER Amputation Without RPNI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2017-06-08 |
| Est. Completion | 2023-06-26 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07285486
The ClinicalTrials.gov registry entry for NCT07285486 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Amputation with Regenerative Peripheral Nerve Interfaces (RPNI) is the first listed.
NCT07285486 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07285486 about?
NCT07285486 is a clinical study titled "Regenerative Peripheral Nerve Interfaces for the Treatment of Painful Neuromas in Major Limb Amputees". The Regenerative Peripheral Nerve Interface (RPNI) is a novel strategy to prevent neuroma formation in transected peripheral nerves. The RPNI consists of a residual peripheral nerve that is implanted into a free skeletal muscle graft either at the time of limb amputation or after excision of a termi...
What is the current status of trial NCT07285486?
This trial is currently completed. The enrollment target is 132 participants. The study started on 2017-06-08. Estimated completion is 2023-06-26.
What interventions are being tested in trial NCT07285486?
The interventions under investigation include: Amputation with Regenerative Peripheral Nerve Interfaces (RPNI) (PROCEDURE), Amputation Without RPNI (OTHER).
Who is sponsoring clinical trial NCT07285486?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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