Surgical Decompression for Diabetic Neuropathy in the Foot
This study has been completed.
Sponsor:
Timothy J. Best Medicine Professional Corporation
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Timothy J. Best Medicine Professional Corporation
ClinicalTrials.gov Identifier:
NCT01006915
First received: October 16, 2009
Last updated: May 4, 2016
Last verified: May 2016
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Purpose
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 | Intervention |
|---|---|
|
Diabetic Polyneuropathy |
Procedure: Surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Surgical Peripheral Nerve Decompression for the Treatment of Diabetic Neuropathy in the Foot |
Resource links provided by NLM:
Further study details as provided by Timothy J. Best Medicine Professional Corporation:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Neuropathic Symptoms as measured by the Total Neuropathy Score (TNS) [ Time Frame: 0,3,6, and 12 months ] [ Designated as safety issue: No ]
- Signs of peripheral neuropathy - two-point discriminations and pressure thresholds, vibration sensibility [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]
- Nerve Conduction Velocity [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: 0,3,6, and 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 21 |
| Study Start Date: | March 2010 |
| Study Completion Date: | March 2016 |
| Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006915
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006915
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 |
| Study First Received: | October 16, 2009 |
| Last Updated: | May 4, 2016 |
| Health Authority: | Canada: Health Canada |
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 |
ClinicalTrials.gov processed this record on September 23, 2016