Surgical Decompression for Diabetic Neuropathy in the Foot
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ClinicalTrials.gov Identifier: NCT01006915 |
Recruitment Status :
Completed
First Posted : November 3, 2009
Last Update Posted : May 5, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Polyneuropathy | Procedure: Surgery | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Surgical decompression
Surgical decompression of the common peroneal, tibial, and deep peroneal nerves
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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
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- 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 ]
- Neuropathic Symptoms as measured by the Total Neuropathy Score (TNS) [ Time Frame: 0,3,6, and 12 months ]
- Signs of peripheral neuropathy - two-point discriminations and pressure thresholds, vibration sensibility [ Time Frame: 0 and 12 months ]
- Nerve Conduction Velocity [ Time Frame: 0 and 12 months ]
- Quality of Life [ Time Frame: 0,3,6, and 12 months ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006915
Canada, Ontario | |
Sault Area Hospital | |
Sault Ste. Marie, Ontario, Canada, P6A 2C4 |
Principal Investigator: | Timothy J Best, MD, MSc | Northern Ontario School of Medicine | |
Study Director: | Sante Fratesi, MD, MSc | Northern Ontario School of Medicine |
Responsible Party: | Timothy J. Best Medicine Professional Corporation |
ClinicalTrials.gov Identifier: | NCT01006915 |
Other Study ID Numbers: |
DPNPSI-1 |
First Posted: | November 3, 2009 Key Record Dates |
Last Update Posted: | May 5, 2016 |
Last Verified: | May 2016 |
Diabetic sensorimotor polyneuropathy |
Diabetic Neuropathies Polyneuropathies Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |