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AxoGuard® Nerve Cap for Morton's Neuroma (REPOSE Trial)

N/A
Waitlist Available
Research Sponsored by Axogen Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6, 9, and 12 months
Awards & highlights

REPOSE Trial Summary

This trial is testing a new way to treat nerve pain in the foot, which may be safer and more effective than surgery.

Eligible Conditions
  • Morton's Neuroma
  • Neuropathic Pain

REPOSE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6, 9, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6, 9, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain
Change in Visual Analog Scale (VAS) For Pain Score at 3 post-operative months in Pilot Phase Subjects
Safety: Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs)
+1 more
Secondary outcome measures
Pain
Change in Foot Health Status Questionnaire (FHSQ) Score at 1,3,6,9, and 12 post-operative months compared to baseline.
Changes in Visual Analog Scale (VAS) For Pain score through 12 post-operative months compared to baseline.
+2 more

REPOSE Trial Design

2Treatment groups
Active Control
Group I: AxoGuard® Nerve CapActive Control1 Intervention
Porcine derived extracellular matrix (ECM) based Nerve Termination Device Implantation of appropriate diameter of AxoGuard® Nerve Cap at the time of surgery
Group II: Standard NeurectomyActive Control1 Intervention
Standard surgical treatment for symptomatic neuroma entailing neuroma excision.

Find a Location

Who is running the clinical trial?

Axogen CorporationLead Sponsor
10 Previous Clinical Trials
5,487 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many health care facilities are currently hosting this experiment?

"Gateway Clinical Trials in O'Fallon, Illinois, New Hope Podiatry Group in Los Angeles, California, and EHI Clinical Research in Roswell, Georgia are among the 15 locations for this medical trial."

Answered by AI

What should be the main goals of this trial to be considered successful?

"The core purpose of this research project, which will span approximately 12 months, is to assess the alteration in Visual Analog Scale (VAS) For Pain Score among Pilot Phase Subjects at 3 post-operative periods. Additionally, further safety endpoints such as SAEs, AEs and UADEs between treatment groups intend to be evaluated. Also sought after are changes in quantity, quality and class of pain medication use from 1 month through 12 months compared with baseline readings. Lastly, VAS for Pain scores shall be monitored over the same duration relative to initial measurements utilizing a 10 cm line wherein 0 mm equates to no pain on one extreme"

Answered by AI

Is there availability for new participants to join this trial?

"Per the data on clinicaltrials.gov, this medical trial is no longer searching for participants; it was initially posted in October 2018 and last updated in September 2022. Fortunately, 174 other trials are currently recruiting patients at present."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
California
What site did they apply to?
New Hope Podiatry Group
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain
2018. "Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03940963.
~16 spots leftby Apr 2025
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