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

Foot Surgery Center of Northern Colorado

Status: Enrolling

Conditions: Diabetic Peripheral Neuropathy

Treatments: Procedure: Arm A - Non-Diabetic, Gait and Balance

Study type: Observational

Funder types: Other

Identifiers

NCT01735903

OMNI1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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