Surgical Decompression for Diabetic Neuropathy in the Foot

Diabetic Polyneuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006915
• Other study ID #: DPNPSI-1
• 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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Polyneuropathies

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