Objective Measures of Nerve Integrity, Posture, Gait and Blood Flow, After Nerve Decompression In diabetiC Neuropathy PatiENTs
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Peripheral Neuropathy
- Sponsor
- Foot Surgery Center of Northern Colorado
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
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.
Detailed Description
Nerve decompression (ND)as treatment for the foot complications of diabetic sensorimotor peripheral neuropathy (DSPN) is a controversial topic although many patients find it provides gratifying relief of pain and numbness. Neural electrical monitoring has been used intra-operatively to diagnosis nerve abnormality, monitoring for ongoing normal nerve function and confirm nerve integrity for spine surgeries and thyroid surgeries with success. Presently there is not objective data to indicate the the use of neural electrical monitoring is reliable or effective. The goal of this study is to measure objectively and quantifiable clinical surgical outcomes of nerve decompression surgery in diabetic neuropathy patients. The study is designed to measure changes in nerve function, gait, balance and blood flow in the lower limb.
Investigators
James Anderson, DPM
Principal Investigator
Foot Surgery Center of Northern Colorado
Eligibility Criteria
Inclusion Criteria
- •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
- •Exclusions Criteria:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Time Frame: 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.
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
Secondary Outcomes
- 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.)