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Completed

NCT Number: NCT01006915

Surgical Decompression for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sault Area Hospital

Sault Ste. Marie, Ontario, P6A 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

Surgical decompression of the common peroneal, tibial, and deep peroneal nerves

Primary outcomes

  1. 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

  1. Neuropathic Symptoms as measured by the Total Neuropathy Score (TNS)

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

  2. Signs of peripheral neuropathy - two-point discriminations and pressure thresholds, vibration sensibility

    Time frame: 0 and 12 months

  3. Nerve Conduction Velocity

    Time frame: 0 and 12 months

  4. Quality of Life

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

Sponsors and collaborators

Lead sponsor

Timothy J. Best Medicine Professional Corporation

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Nov 3, 2009
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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