Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT01735903
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01735903
Study Brief:
Protocol Section:
NCT01735903