Surgical Decompression for Diabetic Neuropathy in the Foot

May 4, 2016 updated by: Timothy J. Best Medicine Professional Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Sault Ste. Marie, Ontario, Canada, P6A 2C4
        • Sault Area Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
0,3,6, and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Timothy J. Best Medicine Professional Corporation

Collaborators

The Physicians' Services Incorporated Foundation

Investigators

  • Principal Investigator: Timothy J Best, MD, MSc, Northern Ontario School of Medicine
  • Study Director: Sante Fratesi, MD, MSc, Northern Ontario School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

October 16, 2009

First Submitted That Met QC Criteria

November 2, 2009

First Posted (Estimate)

November 3, 2009

Study Record Updates

Last Update Posted (Estimate)

May 5, 2016

Last Update Submitted That Met QC Criteria

May 4, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPNPSI-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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