Surgical Decompression for Diabetic Neuropathy in the Foot
Study Details
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 |
|---|---|---|
|
N/A |
Study Design
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
- To determine if lower extremity nerve decompression in patients suffering from symptomatic diabetic peripheral neuropathy significantly alleviates pain. [0,3,6, and 12 months]
Secondary Outcome Measures
- Neuropathic Symptoms as measured by the Total Neuropathy Score (TNS) [0,3,6, and 12 months]
- Signs of peripheral neuropathy - two-point discriminations and pressure thresholds, vibration sensibility [0 and 12 months]
- Nerve Conduction Velocity [0 and 12 months]
- Quality of Life [0,3,6, and 12 months]
Eligibility Criteria
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
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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
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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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DPNPSI-1