Recruitment

Recruitment Status
Recruiting

Inclusion Criteria

Patient has been informed of the nature of the study, agrees to its provisions and has provided written consent
Patient has a positive provocative (i.e. Tinel's sign) observed clinically in the popliteal and tibial nerve trees.
Patient is a type I or type II diabetic that is currently under medical treatment
...
Patient has been informed of the nature of the study, agrees to its provisions and has provided written consent
Patient has a positive provocative (i.e. Tinel's sign) observed clinically in the popliteal and tibial nerve trees.
Patient is a type I or type II diabetic that is currently under medical treatment
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 symptom based VAS scale is 6 or above for at least one of the following: pain, burning, numbness, tingling, weakness or instability
Patient has a Hgb A1C lab value of 8.0% or less
Patient has been diagnosed with diabetic peripheral neuropathy and has nerve deficit in all proposed surgical areas, sensory and/or motor
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 between 18 years and 85 years of age

Exclusion Criteria

Patient is being treated with chemotherapeutic agents
Patient has Raynaud's Syndrome
Patient has blood glucose greater than 200 the day of surgery
...
Patient is being treated with chemotherapeutic agents
Patient has Raynaud's Syndrome
Patient has blood glucose greater than 200 the day of surgery
Patient has untreated hypertension (systolic blood pressure > 160 and/or diastolic > 100)
Patient is a woman who is considering pregnancy or who is pregnant
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
Patient has a BMI of greater than 40 or body weight greater than 300 pounds
Patient is a current smoker
Patient's ASA is 4 or greater
Patient has ankle edema greater than mild - (Moderate to Severe)
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

Summary

Conditions
Diabetic Peripheral Neuropathy
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 85 years
Gender
Both males and females

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 ner...

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.

Inclusion Criteria

Patient has been informed of the nature of the study, agrees to its provisions and has provided written consent
Patient has a positive provocative (i.e. Tinel's sign) observed clinically in the popliteal and tibial nerve trees.
Patient is a type I or type II diabetic that is currently under medical treatment
...
Patient has been informed of the nature of the study, agrees to its provisions and has provided written consent
Patient has a positive provocative (i.e. Tinel's sign) observed clinically in the popliteal and tibial nerve trees.
Patient is a type I or type II diabetic that is currently under medical treatment
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 symptom based VAS scale is 6 or above for at least one of the following: pain, burning, numbness, tingling, weakness or instability
Patient has a Hgb A1C lab value of 8.0% or less
Patient has been diagnosed with diabetic peripheral neuropathy and has nerve deficit in all proposed surgical areas, sensory and/or motor
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 between 18 years and 85 years of age

Exclusion Criteria

Patient is being treated with chemotherapeutic agents
Patient has Raynaud's Syndrome
Patient has blood glucose greater than 200 the day of surgery
...
Patient is being treated with chemotherapeutic agents
Patient has Raynaud's Syndrome
Patient has blood glucose greater than 200 the day of surgery
Patient has untreated hypertension (systolic blood pressure > 160 and/or diastolic > 100)
Patient is a woman who is considering pregnancy or who is pregnant
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
Patient has a BMI of greater than 40 or body weight greater than 300 pounds
Patient is a current smoker
Patient's ASA is 4 or greater
Patient has ankle edema greater than mild - (Moderate to Severe)
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

Tracking Information

NCT #
NCT01735903
Collaborators
Association of Extremity Nerve Surgeons
Investigators
  • Principal Investigator: James C. Anderson, DPM Anderson Podiatry Center
  • James C. Anderson, DPM Anderson Podiatry Center
About Us
Innovation
Privacy
Terms
Copyright
Get Well Soon © Copyright 2024