Recruiting

Observational Study

Sponsor:

Foot Surgery Center of Northern Colorado

Code:

NCT01735903

Conditions

Diabetic Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Arm A - Non-Diabetic, Gait and Balance

Study Details

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.

Conditions

Diabetic Peripheral Neuropathy

Study ID

NCT01735903

Start date

Nov, 2012

Status verified date

Feb, 2021

Completion date

Jul, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome 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 [ 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. ]

Central Contacts and Locations

Central contacts

Megan L Fritz, D.C., M.S.

479-531-6133megan.fritz.dc@gmail.com

James C Anderson, DPM

970-484-4620janderson@andersonpodiatrycenter.com

Locations

Anderson Podiatry Center, Neuropathy Testing Center of Colorado

Recruiting

Fort Collins, Colorado, United States, 80524

Contacts

Megan L Fritz, D.C., M.S.

479-531-6133megan.fritz.dc@gmail.com

James C. Anderson, DPM

970-484-4620janderson@andersonpodiatrycenter.com

Principal Investigator:

James C. Anderson, DPM

More Information

Sponsor

Foot Surgery Center of Northern Colorado

Last update posted

Feb 16, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Foot Surgery Center of Northern Colorado on 2021-02-16.