Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT05008185

Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation

Led by Medstar Health Research Institute · Updated on 2024-11-29

80

Participants Needed

2

Research Sites

199 weeks

Total Duration

On this page

Sponsors

M

Medstar Health Research Institute

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is being done to demonstrate the effectiveness of Regenerative Peripheral Nerve Interfaces (RPNI) surgery in treating symptomatic neuromas of the hand and digits following amputation compared to standard of care using a Prospective, Observational Trial

CONDITIONS

Official Title

Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • History of unilateral digit, multiple digit, or partial hand amputation
  • Discrete neuroma pain on clinical exam
  • Confirmation through a local block and/or ultrasound imaging if indicated following standard of care
  • Must have undergone at least a 6-week trial of desensitization therapy with a hand therapist
Not Eligible

You will not qualify if you...

  • Previous surgical treatment for symptomatic neuromas of the digits or hand
  • Other major injuries on the same side of the body causing chronic pain or loss of function
  • Women who are pregnant at the time of enrollment
  • Prisoners
  • Adults unable to provide consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

The Curtis National Hand Center at Medstar Union Memorial Hospital

Baltimore, Maryland, United States, 21218

Actively Recruiting

2

University of Michigan Plastic Surgery

Ann Arbor, Michigan, United States, 48109

Not Yet Recruiting

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Research Team

I

Isaac C Fleming

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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