Clinical trial NCT01006915: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Polyneuropathy
Keywords: Diabetic sensorimotor polyneuropathy
Lead sponsor: Timothy J. Best Medicine Professional Corporation
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2009-11-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To determine if lower extremity nerve decompression in patients suffering from symptomatic diabetic peripheral neuropathy significantly alleviates pain.
timeFrame: 0,3,6, and 12 months
Secondary outcomes:
measure: Neuropathic Symptoms as measured by the Total Neuropathy Score (TNS)
timeFrame: 0,3,6, and 12 months
measure: Signs of peripheral neuropathy - two-point discriminations and pressure thresholds, vibration sensibility
timeFrame: 0 and 12 months
measure: Nerve Conduction Velocity
timeFrame: 0 and 12 months
measure: Quality of Life
timeFrame: 0,3,6, and 12 months
Other outcomes:
Locations:
city: Sault Ste. Marie
country: Canada
facility: Sault Area Hospital
state: Ontario
Study officials:
affiliation: Northern Ontario School of Medicine
name: Timothy J Best, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Northern Ontario School of Medicine
name: Sante Fratesi, MD, MSc
role: STUDY_DIRECTOR
References: