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

NCT01735903 | Unknown DMC

• 1 other identifier: OMNI1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• EMG signals used intraoperative as objective measurements of change before and after nerve decompression surgery. Gait, balance and blood flow measurements before and after peripheral nerve decompression surgery

  Primary Endpoint is assessed by changes in: * Neuromotor function in the lower limb as measured by intraoperative electromyographic(EMG) recordings of the muscles in the anterior and lateral compartments of the leg and muscles of the foot. * Blood flow in the lower limb both distal to and proximal to the nerve release sites, as measured by duplex doppler of the external femoral artery (a.), superficial femoral a., popliteal a., anterior and posterior tibial a., dorsal pedis a. Shear stress changes in these arteries. * Lower limb performance defined as: * Dorsiflexor strength and speed of contraction * Proprioception at the ankle * One-legged standing balance * Functional reach * Sensory function in the foot * Usual gait speed * Standardized tests of mobility

  Within one month of surgical date, surgical date, 3 months and 6 months post operative or 4 months postoperative if the subjects elect to have the contralateral limb surgery prior to 3 months following the initial surgery.

Secondary Outcomes (1)

• Change in sensory perception

  up to one month of surgical date, 3 months and 6 months post operative or 4 months postoperative if the subjects elect to have the contralateral limb surgery prior to 3 months following the initial surgery.

Interventions

Arm A - Non-Diabetic, Gait and Balance PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Poudre Valley Foot and Ankle Clinic patients and Neuropathy Testing Center of Colorado

You may qualify if:

• 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
• Patient has a BMI of greater than 40 or body weight greater than 300 pounds
• Patient has untreated hypertension (systolic blood pressure \> 160 and/or diastolic \> 100)
• Patient's ASA is 4 or greater
• Patient has blood glucose greater than 200 the day of surgery
• Patient has Raynaud's Syndrome
• Patient is a current smoker

Sponsors & Collaborators

• Foot Surgery Center of Northern Colorado: lead
• Association of Extremity Nerve Surgeons: collaborator

Study Sites (1)

Anderson Podiatry Center, Neuropathy Testing Center of Colorado

Fort Collins, Colorado, 80524, United States

RECRUITING

MeSH Terms

Interventions

Gait

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• James C. Anderson, DPM

  Anderson Podiatry Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan L Fritz, D.C., M.S.

CONTACT

479-531-6133; megan.fritz.dc@gmail.com

James C Anderson, DPM

CONTACT

970-484-4620; janderson@andersonpodiatrycenter.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 28, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

US (1)