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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 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: March 27, 2013
Last verified: March 2013
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • EMG signals used intraoperative as objective measurements 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 ] [ 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:
  • Improvement in sensory perception [ Time Frame: up to one month of surgical date, 3 months and 6 months post operative ] [ 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 2014
Estimated Primary Completion Date: January 2014 (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.

    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
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:

  • Age between 18 years and 85 years;
  • Diagnosed with type I or type II diabetes with symptomatic peripheral neuropathy;
  • Without Diabetes, but with peripheral neuropathy and lower limb pain, paresthesia, gait disturbances, or motor weakness;
  • Nerve deficit in all surgical areas - sensory or motor including:
  • Lower limb pain, paresthesia or motor weakness;
  • Positive Tinel's sign observed clinically in all operative tunnels;
  • Visual Analog Scale (VAS) of 6 or above for: burning, tingling, numbness, pain, weakness and/or instability;
  • Gait disturbances ranging from MILD with lack of sensation in plantar foot - to SEVERE with motor deficit with no sensation in plantar foot;
  • Scheduled for lower limb nerve decompression surgery of common, superficial and deep peroneal nerves and posterior tibial nerves;
  • Medically cleared for outpatient surgery per anesthesia guidelines;
  • Informed of the nature of the study, agrees to its provisions and has provided written consent as approved by Institutional Review Board;
  • Able and willing to comply with all study requirements, including follow-up evaluations at both investigational sites.

Exclusions Criteria:

  • Greater than 60% stenosis of the common femoral artery a., superficial femoral a., popliteal a., anterior and posterior tibial aa, or dorsal pedis a.;
  • Untreated hypertension;
  • BMI > 40 or body weight > 300 pounds;
  • Blood glucose greater than 200 the day of surgery or hemoglobin A1c > 8.0;
  • American Society of Anesthesiologist (ASA) level of 4 or greater;
  • Current smoker;
  • Diagnosis of Raynaud's Syndrome;
  • History of recent nerve or lumbar disc surgery, untreated thyroid disease, B12 or Folate deficiency, hepatic disease, renal disease, and/or Parkinson's disease;
  • Ankle edema > Mild;
  • Current treatment with chemotherapeutic agents;
  • 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;
  • Women considering pregnancy or are pregnant.
  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: Mary E. Browne, RN 970-449-8480 ext 119 mbrowne@pvfac.com

Locations
United States, Colorado
Poudre Valley Foot and Ankle Clinic, Neuropathy Testing Center of Colorado Recruiting
Fort Collins, Colorado, United States, 80524
Contact: Mary E. Browne, RN    970-449-8480 ext 119    mbrowne@pvfac.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 Poudre Valley Foot and Ankle Clinic
  More Information

No publications provided

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: March 27, 2013
Health Authority: Poudre Valley Health System, United States of America:
Institutional Review Board, United States of America:

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

ClinicalTrials.gov processed this record on July 31, 2014