Loading clinical trials...

Surgical Decompression for Diabetic Neuropathy in the Foot | Clinical Trials | Clareo Health

COMPLETEDNA

Surgical Decompression for Diabetic Neuropathy in the Foot

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

NCT01006915•Timothy J. Best Medicine Professional Corporation

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Sault Area Hospital

Sault Ste. Marie, Ontario, Canada

Key Dates

Start Date

March 1, 2010

Primary Completion Date

March 1, 2015

Completion Date

March 1, 2016

Last Updated

May 5, 2016

Enrollment

ACTUAL participants

Conditions

Diabetic Polyneuropathy

Interventions

Surgery

PROCEDURE

Effect of Feldenkrais Method in Enhancing Postural Control for Patients with Diabetic Polyneuropathy

NCT06904417

Diabetic Polyneuropathy

View study

NOT_YET_RECRUITING

Serum Neurofilament Light Chain Levels and Neuropathy Severity in Diabetic Polyneuropathy

NCT07480330

Diabetic Polyneuropathy

View study

NOT_YET_RECRUITING

PULP SENSIBILITY AND MASSETER INHIBITORY REFLEX IN DIABETIC POLYNEUROPATHY

NCT07369297

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 5, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Surgical Decompression for Diabetic Neuropathy in the Foot

Inclusion Criteria

Exclusion Criteria

Effect of Feldenkrais Method in Enhancing Postural Control for Patients with Diabetic Polyneuropathy

Serum Neurofilament Light Chain Levels and Neuropathy Severity in Diabetic Polyneuropathy

PULP SENSIBILITY AND MASSETER INHIBITORY REFLEX IN DIABETIC POLYNEUROPATHY

A Double-Blind, Placebo-Controlled Study of Fermented Deglycyrrhizinated Licorice Extract

VR in Diabetic Polyneuropathy

Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study