Surgical Decompression for Diabetic Neuropathy in the Foot

NCT ID: NCT01006915

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2016-03-31

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.

Conditions

Diabetic Polyneuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgical decompression

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

Group Type: EXPERIMENTAL

Surgery

Intervention Type: PROCEDURE

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

Standard medical care

Standard diabetic care and medical care provided for diabetic sensorimotor polyneuropathy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Surgery

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

Timothy J. Best Medicine Professional Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy J Best, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Northern Ontario School of Medicine

Sante Fratesi, MD, MSc

Role: STUDY_DIRECTOR

Northern Ontario School of Medicine

Locations

Sault Area Hospital

Sault Ste. Marie, Ontario, Canada

Countries

Canada

Other Identifiers

DPNPSI-1

Identifier Type: -

Identifier Source: org_study_id