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

Diabetic Peripheral Neuropathy Clinical Trial

— OMNIFICENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01735903
• Other study ID #: OMNI1
• Status: Recruiting
• Start date: November 2012
• Est. completion date: July 2025

Study information

• Verified date: February 2021
• Source: Foot Surgery Center of Northern Colorado
• Contact: Megan L Fritz, D.C., M.S.
• Phone: 479-531-6133
• Email: megan.fritz.dc[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Procedure:
• Arm A - Non-Diabetic, Gait and Balance
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.

Locations

Country	Name	City	State
United States	Anderson Podiatry Center, Neuropathy Testing Center of Colorado	Fort Collins	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Foot Surgery Center of Northern Colorado	Association of Extremity Nerve Surgeons

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in sensory perception	Two-point discrimination; Changes in nerve conduction measures; Changes in ankle-brachial index (ABI); Visual Analog Score (VAS) for neuropathic symptoms	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.