Surgical Decompression for Diabetic Neuropathy in the Foot

• ClinicalTrials.gov Identifier: NCT01006915
• Recruitment Status: Completed
• First Posted: November 3, 2009
• Last Update Posted: May 5, 2016
• Sponsor: Timothy J. Best Medicine Professional Corporation
• Collaborator: The Physicians' Services Incorporated Foundation
• Information provided by (Responsible Party): Timothy J. Best Medicine Professional Corporation

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.

Condition or disease	Intervention/treatment	Phase
Diabetic Polyneuropathy	Procedure: Surgery	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Surgical Peripheral Nerve Decompression for the Treatment of Diabetic Neuropathy in the Foot
• Study Start Date: March 2010
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: March 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Surgical decompression; Surgical decompression of the common peroneal, tibial, and deep peroneal nerves	Procedure: Surgery; Surgical decompression of the common peroneal, tibial, and deep peroneal nerves
No Intervention: Standard medical care; Standard diabetic care and medical care provided for diabetic sensorimotor polyneuropathy

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. Neuropathic Symptoms as measured by the Total Neuropathy Score (TNS) [ Time Frame: 0,3,6, and 12 months ]
2. Signs of peripheral neuropathy - two-point discriminations and pressure thresholds, vibration sensibility [ Time Frame: 0 and 12 months ]
3. Nerve Conduction Velocity [ Time Frame: 0 and 12 months ]
4. Quality of Life [ Time Frame: 0,3,6, and 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Ontario

Sault Area Hospital

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

Sponsors and Collaborators

Timothy J. Best Medicine Professional Corporation

The Physicians' Services Incorporated Foundation

Investigators

• Principal Investigator: Timothy J Best, MD, MSc; Northern Ontario School of Medicine
• Study Director: Sante Fratesi, MD, MSc; Northern Ontario School of Medicine

More Information

• Responsible Party: Timothy J. Best Medicine Professional Corporation
• ClinicalTrials.gov Identifier: NCT01006915 History of Changes
• Other Study ID Numbers: DPNPSI-1
• First Posted: November 3, 2009
• Last Update Posted: May 5, 2016
• Last Verified: May 2016

Keywords provided by Timothy J. Best Medicine Professional Corporation:

Diabetic sensorimotor polyneuropathy

Additional relevant MeSH terms:

Diabetic Neuropathies; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases