RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2012-11

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01735903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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
* 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

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

CONTACT

479-531-6133

megan.fritz.dc@gmail.com

James C Anderson, DPM

CONTACT

970-484-4620

janderson@andersonpodiatrycenter.com

Principal Investigator

James C. Anderson, DPM

PRINCIPAL_INVESTIGATOR

Anderson Podiatry Center

Study Locations (Sites)

Anderson Podiatry Center, Neuropathy Testing Center of Colorado

Fort Collins, Colorado, 80524

United States

Collaborators and Investigators

Sponsor: Foot Surgery Center of Northern Colorado

James C. Anderson, DPM, PRINCIPAL_INVESTIGATOR, Anderson Podiatry Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-11

Study Completion Date2025-07

Study Record Updates

Study Start Date2012-11

Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

Diabetic Peripheral Neuropathy