Surgical Peripheral Nerve Decompression for the Treatment of Diabetic Neuropathy in the Foot

Timothy J. Best Medicine Professional Corporation1 site in 1 country21 target enrollmentMarch 2010

ConditionsDiabetic Polyneuropathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Polyneuropathy
Sponsor: Timothy J. Best Medicine Professional Corporation
Enrollment: 21
Locations: 1
Primary Endpoint: To determine if lower extremity nerve decompression in patients suffering from symptomatic diabetic peripheral neuropathy significantly alleviates pain.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to determine whether or not surgical decompression of the common peroneal, tibial, and deep peroneal nerves in the legs of persons with diabetic peripheral neuropathy is effective treatment.

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

March 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Timothy J. Best Medicine Professional Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \>18 years
•Presence of Type 1 or 2 diabetes mellitus (fasting plasma glucose \> 7 mmol/L or casual plasma glucose \> 11.1 mmol/L and symptoms of diabetes or a 2hr plasma glucose in a 75g oral glucose tolerance test \> 11.1 mmol/L)
•Symptoms of paresthesias (including burning pain) or numbness present symmetrically in both feet, determined to be on a peripheral nerve basis
•Total Neuropathy score of ≥ 2 based on symptoms, signs, and nerve conduction study abnormality
•Average pain on Likert scale (range 0 - 10) ≥5
•Good diabetic control with Hgb A1C \< 8
•Presence of Tinel's sign at the Tarsal Tunnel
•Possession of valid Ontario Hospital Insurance Plan (OHIP) coverage

Exclusion Criteria

•Other types of diabetes mellitus (gestational, drug-induced, etc.)
•Other cause of neuropathy than diabetes such as vasculitis, amyloidosis, toxic neuropathy, HIV, renal failure, alcohol abuse, etc. Pure entrapment neuropathy without evidence of DSP
•Symptomatic lumbosacral spine disease
•Symptomatic lower extremity vascular disease
•Previous foot ulceration or amputation. Other contraindications to surgery such as significant ankle edema, venous stasis, morbid obesity, or previous surgery/injury which would be incompatible with appropriate wound healing
•History of Peripheral Arterial Disease
•HbA1c \> 8.0 - Adults lacking capacity to consent, pregnant women, prisoners, non-English speakers who require an interpreter, and those unwilling or unable to participate in the full study follow-up

Outcomes

Primary Outcomes

To determine if lower extremity nerve decompression in patients suffering from symptomatic diabetic peripheral neuropathy significantly alleviates pain.

Time Frame: 0,3,6, and 12 months

Secondary Outcomes

Nerve Conduction Velocity(0 and 12 months)
Neuropathic Symptoms as measured by the Total Neuropathy Score (TNS)(0,3,6, and 12 months)
Quality of Life(0,3,6, and 12 months)
Signs of peripheral neuropathy - two-point discriminations and pressure thresholds, vibration sensibility(0 and 12 months)