Surgical Decompression for Diabetic Neuropathy in the Foot

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Polyneuropathy

Intervention / Treatment
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* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical decompression<br>Surgical decompression of the common peroneal, tibial, and deep peroneal nerves | Procedure: Surgery<br>* Surgical decompression of the common peroneal, tibial, and deep peroneal nerves<br>|
| No Intervention: Standard medical care<br>Standard diabetic care and medical care provided for diabetic sensorimotor polyneuropathy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if lower extremity nerve decompression in patients suffering from symptomatic diabetic peripheral neuropathy significantly alleviates pain. |  | 0,3,6, and 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic sensorimotor polyneuropathy