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Objective Measures of Nerve Integrity, Posture, Gait and Blood Flow, After Nerve Decompression

NCT01735903 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-02-16

No results posted yet for this study

Summary

The purpose of this study is to measure the effect of nerve decompression on the recovery of the treated nerves. To obtain objective data during surgery of the treated nerves' via electrical signals and muscle power when stimulated. Also, to monitor muscle strength, balance/gait and blood flow in the lower extremity before and after surgery.

Conditions

  • Diabetic Peripheral Neuropathy

Interventions

PROCEDURE

Arm A - Non-Diabetic, Gait and Balance

Arm A will enroll patients WITHOUT diabetes, but with peripheral neuropathy and lower limb pain, paresthesia, gait disturbances, or motor weakness and will follow the same protocol except the subject will NOT participate in blood flow testing performed at Colorado State University, and therefore do not include the inclusion/exclusion criterion that are specifically related to the blood flow assessment. Subjects may have any combination of lower limb nerve decompression surgery of the listed surgical sites with or without the addition of Soleal Sling Decompression. Soleal Sling Decompression surgical procedure will require the use of a thigh tourniquet.

Sponsors & Collaborators

  • Association of Extremity Nerve Surgeons

    collaborator OTHER

  • Foot Surgery Center of Northern Colorado

    lead OTHER

Principal Investigators

  • James C. Anderson, DPM · Anderson Podiatry Center

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2025-01-31
Completion
2025-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01735903 on ClinicalTrials.gov