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Surgical Decompression for Diabetic Neuropathy in the Foot

Primary Purpose

Diabetic Polyneuropathy

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Surgery

About this trial

This is an interventional treatment trial for Diabetic Polyneuropathy focused on measuring Diabetic sensorimotor polyneuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sault Area Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgical decompression

Standard medical care

Arm Description

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

Standard diabetic care and medical care provided for diabetic sensorimotor polyneuropathy

Outcomes

Primary Outcome Measures

To determine if lower extremity nerve decompression in patients suffering from symptomatic diabetic peripheral neuropathy significantly alleviates pain.

Secondary Outcome Measures

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

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

Nerve Conduction Velocity

Quality of Life

Full Information

NCT ID

NCT01006915

First Posted

October 16, 2009

Last Updated

May 4, 2016

Sponsor

Timothy J. Best Medicine Professional Corporation

Collaborators

The Physicians' Services Incorporated Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01006915

Brief Title

Surgical Decompression for Diabetic Neuropathy in the Foot

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Timothy J. Best Medicine Professional Corporation

Collaborators

The Physicians' Services Incorporated Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Polyneuropathy

Keywords

Diabetic sensorimotor polyneuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Surgical decompression

Arm Type

Experimental

Arm Description

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

Arm Title

Standard medical care

Arm Type

No Intervention

Arm Description

Standard diabetic care and medical care provided for diabetic sensorimotor polyneuropathy

Intervention Type

Procedure

Intervention Name(s)

Surgery

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Time Frame

0,3,6, and 12 months

Title

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

Time Frame

0 and 12 months

Title

Nerve Conduction Velocity

Time Frame

0 and 12 months

Title

Quality of Life

Time Frame

0,3,6, and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy J Best, MD, MSc

Organizational Affiliation

Northern Ontario School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sante Fratesi, MD, MSc

Organizational Affiliation

Northern Ontario School of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Sault Area Hospital

City

Sault Ste. Marie

State/Province

Ontario

ZIP/Postal Code

P6A 2C4

Country

Canada

12. IPD Sharing Statement

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Surgical Decompression for Diabetic Neuropathy in the Foot

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