Clinical trial NCT01735903: Objective Measures of Nerve Integrity, Posture, Gait and Blood Flow, After Nerve Decompression
Official title: Objective Measures of Nerve Integrity, Posture, Gait and Blood Flow, After Nerve Decompression In diabetiC Neuropathy PatiENTs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Foot Surgery Center of Northern Colorado
Sponsor class: OTHER
Collaborators: name: Association of Extremity Nerve Surgeons
First posted: 2012-11-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Poudre Valley Foot and Ankle Clinic patients and Neuropathy Testing Center of Colorado

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.

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:

* 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
* Patient is a woman who is considering pregnancy or who is pregnant
* Patient has history of recent nerve or lumbar disc surgery, untreated thyroid disease, B12 or Folate deficiency, hepatic disease, renal disease, and/or Parkinson's disease, or neuropathy due to chemotherapy or radiation therapy
* Patient is being treated with chemotherapeutic agents
* Patient has ankle edema greater than mild - (Moderate to Severe)
* Patient is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint

Primary outcomes:
measure: 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
timeFrame: 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:
measure: Change in sensory perception
timeFrame: 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.
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Anderson Podiatry Center, Neuropathy Testing Center of Colorado
state: Colorado
Study officials:
affiliation: Anderson Podiatry Center
name: James C. Anderson, DPM
role: PRINCIPAL_INVESTIGATOR
References: