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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01006915
Other study ID # DPNPSI-1
Secondary ID
Status Completed
Phase N/A
First received October 16, 2009
Last updated May 4, 2016
Start date March 2010
Est. completion date March 2016

Study information

Verified date May 2016
Source Timothy J. Best Medicine Professional Corporation
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date March 2016
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Procedure:
Surgery
Surgical decompression of the common peroneal, tibial, and deep peroneal nerves

Locations

Country Name City State
Canada Sault Area Hospital Sault Ste. Marie Ontario

Sponsors (2)

Lead Sponsor Collaborator
Timothy J. Best Medicine Professional Corporation The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine if lower extremity nerve decompression in patients suffering from symptomatic diabetic peripheral neuropathy significantly alleviates pain. 0,3,6, and 12 months No
Secondary Neuropathic Symptoms as measured by the Total Neuropathy Score (TNS) 0,3,6, and 12 months No
Secondary Signs of peripheral neuropathy - two-point discriminations and pressure thresholds, vibration sensibility 0 and 12 months No
Secondary Nerve Conduction Velocity 0 and 12 months No
Secondary Quality of Life 0,3,6, and 12 months No
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