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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Foot Surgery Center of Northern Colorado
Sponsor:
Collaborator:
Association of Extremity Nerve Surgeons
Information provided by (Responsible Party):
James Anderson, DPM, Foot Surgery Center of Northern Colorado
ClinicalTrials.gov Identifier:
NCT01735903
First received: November 15, 2012
Last updated: August 8, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Diabetic Peripheral Neuropathy
Procedure: Arm A - Non-Diabetic, Gait and Balance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Objective Measures of Nerve Integrity, Posture, Gait and Blood Flow, After Nerve Decompression In diabetiC Neuropathy PatiENTs

Further study details as provided by Foot Surgery Center of Northern Colorado:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Change in sensory perception [ Time Frame: 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. ] [ Designated as safety issue: No ]
    • Two-point discrimination
    • Changes in nerve conduction measures
    • Changes in ankle-brachial index (ABI)
    • Visual Analog Score (VAS) for neuropathic symptoms


Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

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

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Poudre Valley Foot and Ankle Clinic patients and Neuropathy Testing Center of Colorado
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735903

Contacts
Contact: Megan L Fritz, D.C., M.S. 479-531-6133 megan.fritz.dc@gmail.com
Contact: James C Anderson, DPM 970-484-4620 janderson@andersonpodiatrycenter.com

Locations
United States, Colorado
Anderson Podiatry Center, Neuropathy Testing Center of Colorado Recruiting
Fort Collins, Colorado, United States, 80524
Contact: Megan L Fritz, D.C., M.S.    479-531-6133    megan.fritz.dc@gmail.com   
Contact: James C. Anderson, DPM    970-484-4620    janderson@andersonpodiatrycenter.com   
Principal Investigator: James C. Anderson, DPM         
Sponsors and Collaborators
Foot Surgery Center of Northern Colorado
Association of Extremity Nerve Surgeons
Investigators
Principal Investigator: James C. Anderson, DPM Anderson Podiatry Center
  More Information

Responsible Party: James Anderson, DPM, Principal Investigator, Foot Surgery Center of Northern Colorado
ClinicalTrials.gov Identifier: NCT01735903     History of Changes
Other Study ID Numbers: OMNI1 
Study First Received: November 15, 2012
Last Updated: August 8, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on December 02, 2016