NCT01006915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2009

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

5 years

First QC Date

October 16, 2009

Last Update Submit

May 4, 2016

Conditions

Diabetic Polyneuropathy

Keywords

Diabetic sensorimotor polyneuropathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

Surgical decompression

EXPERIMENTAL

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

Procedure: Surgery

Standard medical care

NO INTERVENTION

Standard diabetic care and medical care provided for diabetic sensorimotor polyneuropathy

Interventions

SurgeryPROCEDURE

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

Surgical decompression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sault Area Hospital

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

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Timothy J Best, MD, MSc

    Northern Ontario School of Medicine

    PRINCIPAL INVESTIGATOR

  • Sante Fratesi, MD, MSc

    Northern Ontario School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2009

First Posted

November 3, 2009

Study Start

March 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2016

Last Updated

May 5, 2016

Record last verified: 2016-05

Locations

CA(1)