Objective Measures of Nerve Integrity, Posture, Gait and Blood Flow, After Nerve Decompression In diabetiC Neuropathy PatiENTs

Status: Unknown
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Patient has been diagnosed with diabetic peripheral neuropathy and has nerve deficit in all proposed surgical areas, sensory and/or motor

• Patient has a positive provocative (i.e. Tinel's sign) observed clinically in the popliteal and tibial nerve trees.

• Patient is between 18 years and 85 years of age

• Patient is a type I or type II diabetic that is currently under medical treatment

• Patient has a Hgb A1C lab value of 8.0% or less

• Patient symptom based VAS scale is 6 or above for at least one of the following: pain, burning, numbness, tingling, weakness or instability

• Patient is scheduled for surgery and has been cleared for outpatient surgery per anesthesia guidelines established for the Foot Surgery Center of Northern Colorado

• Patient is able and willing to comply with all study requirements, including the follow-up evaluations and will return to the investigational site for all required office visits and CSU visits

• Patient has been informed of the nature of the study, agrees to its provisions and has provided written consent

Locations
United States
Colorado
Anderson Podiatry Center, Neuropathy Testing Center of Colorado
RECRUITING
Fort Collins
Contact Information
Primary
Megan L Fritz, D.C., M.S.
megan.fritz.dc@gmail.com
479-531-6133
Backup
James C Anderson, DPM
janderson@andersonpodiatrycenter.com
970-484-4620
Time Frame
Start Date: 2012-11
Completion Date: 2025-07
Participants
Target number of participants: 40
Sponsors
Collaborators: Association of Extremity Nerve Surgeons
Leads: Foot Surgery Center of Northern Colorado

This content was sourced from clinicaltrials.gov