Diabetic PolyneuropathyNCT01006915
Surgical Decompression for Diabetic Neuropathy in the Foot
A study testing Surgery in people with Diabetic Polyneuropathy, run by Timothy J. Best Medicine Professional Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Peripheral Nerve Decompression for the Treatment of Diabetic Neuropathy in the Foot
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
- Being tested
- Surgery
- Keywords
- Diabetic sensorimotor polyneuropathy
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Surgical decompression of the common peroneal, tibial, and deep peroneal nerves
| Study group | Role | What they receive |
|---|---|---|
| Surgical decompression | Experimental | Surgical decompression of the common peroneal, tibial, and deep peroneal nerves Receives: Procedure: Surgery |
| Standard medical care | No intervention | Standard diabetic care and medical care provided for diabetic sensorimotor polyneuropathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if lower extremity nerve decompression in patients suffering from symptomatic diabetic peripheral neuropathy significantly alleviates pain.
Measured: 0,3,6, and 12 months
Secondary outcomes (4)
Neuropathic Symptoms as measured by the Total Neuropathy Score (TNS)
Measured: 0,3,6, and 12 months
Signs of peripheral neuropathy - two-point discriminations and pressure thresholds, vibration sensibility
Measured: 0 and 12 months
Nerve Conduction Velocity
Measured: 0 and 12 months
Quality of Life
Measured: 0,3,6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startMar 2010
- Primary completionMar 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy J. Best Medicine Professional Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Timothy J Best, MD, MSc, Principal investigator, Northern Ontario School of MedicineSante Fratesi, MD, MSc, Study director, Northern Ontario School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006915
- Sponsor's protocol ID
- DPNPSI-1
- Status last verified
- May 2016
- First submitted
- 16 Oct 2009
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Peripheral Nerve Decompression for the Treatment of Diabetic Neuropathy in the Foot
- ClinicalTrials.gov ID
- NCT01006915
- Acronym / sponsor ID
- DPNPSI-1
- Conditions
- Diabetic Polyneuropathy
- Keywords
- Diabetic sensorimotor polyneuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Timothy J. Best Medicine Professional CorporationUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Mar 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 3 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical decompression | Experimental | Procedure: SurgerySurgical decompression of the common peroneal, tibial, and deep peroneal nerves |
| Standard medical care | No intervention | –Standard diabetic care and medical care provided for diabetic sensorimotor polyneuropathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgerySurgical decompression of the common peroneal, tibial, and deep peroneal nerves | Procedure or surgery | Surgical decompression |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy J Best, MD, MSc principal investigator
Northern Ontario School of Medicine
Sante Fratesi, MD, MSc study director
Northern Ontario School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery in people with Diabetic Polyneuropathy, run by Timothy J. Best Medicine Professional Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.