Surgical Decompression for Diabetic Neuropathy in the Foot

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Timothy J. Best Medicine Professional Corporation.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Timothy J. Best Medicine Professional Corporation
ClinicalTrials.gov Identifier:
NCT01006915
First received: October 16, 2009
Last updated: December 19, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Diabetic Polyneuropathy
Procedure: Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgical Peripheral Nerve Decompression for the Treatment of Diabetic Neuropathy in the Foot

Resource links provided by NLM:


Further study details as provided by Timothy J. Best Medicine Professional Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropathic Symptoms as measured by the Total Neuropathy Score (TNS) [ Time Frame: 0,3,6, and 12 months ] [ Designated as safety issue: No ]
  • Signs of peripheral neuropathy - two-point discriminations and pressure thresholds, vibration sensibility [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]
  • Nerve Conduction Velocity [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 0,3,6, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006915

Contacts
Contact: Susan McLean, RN 888-779-1166 susan.mclean@superiorfht.ca

Locations
Canada, Ontario
Sault Area Hospital Recruiting
Sault Ste. Marie, Ontario, Canada, P6A 2C4
Contact: Susan McLean, RN    888-779-1166    susan.mclean@superiorfht.ca   
Principal Investigator: Timothy J Best, MD, MSc         
Sub-Investigator: Sante Fratesi, MD, MSc         
Sponsors and Collaborators
Timothy J. Best Medicine Professional Corporation
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
  More Information

No publications provided

Responsible Party: Timothy J. Best Medicine Professional Corporation
ClinicalTrials.gov Identifier: NCT01006915     History of Changes
Other Study ID Numbers: DPNPSI-1
Study First Received: October 16, 2009
Last Updated: December 19, 2011
Health Authority: Canada: Health Canada

Keywords provided by Timothy J. Best Medicine Professional Corporation:
Diabetic sensorimotor polyneuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014