Surgical Decompression for Diabetic Neuropathy in the Foot

Not Applicable

Completed

• Conditions: Diabetic Polyneuropathy

• Registration Number: NCT01006915
• Lead Sponsor: Timothy J. Best Medicine Professional Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-16
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Study Start: 2010-03
• Primary Completion: 2015-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-04
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Sault Area Hospital; 🇨🇦 Sault Ste. Marie, Ontario, Canada