Measuring nerve recovery after nerve decompression surgery for diabetic neuropathy
Objective Measures of Nerve Integrity, Posture, Gait and Blood Flow, After Nerve Decompression In diabetiC Neuropathy PatiENTs
Foot Surgery Center of Northern Colorado · NCT01735903
This study is testing how nerve decompression surgery can help people with diabetic neuropathy recover their nerve function and improve their mobility.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Foot Surgery Center of Northern Colorado (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Fort Collins, Colorado) |
| Trial ID | NCT01735903 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effects of nerve decompression surgery on nerve recovery in patients with diabetic peripheral neuropathy. It will collect objective data during surgery by monitoring electrical signals and muscle power, as well as evaluating muscle strength, balance, gait, and blood flow in the lower extremities before and after the procedure. The study seeks to provide quantifiable outcomes regarding the effectiveness of nerve decompression in improving nerve function and overall patient mobility.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 85 diagnosed with diabetic peripheral neuropathy and experiencing significant nerve deficits.
Not a fit: Patients who do not have diabetic peripheral neuropathy or those with uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide objective evidence supporting nerve decompression as an effective treatment for diabetic peripheral neuropathy.
How similar studies have performed: While the use of neural electrical monitoring has shown success in other surgical contexts, this specific application in diabetic neuropathy is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fort Collins, Colorado
- Anderson Podiatry Center, Neuropathy Testing Center of Colorado — Fort Collins, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: James C. Anderson, DPM — Anderson Podiatry Center
- Study coordinator: Megan L Fritz, D.C., M.S.
- Email: megan.fritz.dc@gmail.com
- Phone: 479-531-6133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Peripheral Neuropathy