DiabetesNCT02363803

Lidocaine for Diabetic Peripheral Neuropathy

A study testing lidocaine in people with Diabetes and Peripheral Neuropathy, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Diabetic nerve pain [painful diabetic peripheral neuropathy] is a common medical problem with few reliably effective treatments. There is some evidence that sensory testing may help determine how individuals will respond to analgesic therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Peripheral Neuropathy, Pain
What is being tested?: lidocaine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteUnited States
Study dates: Feb 2015to 17 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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;
Diagnosis of Diabetes Mellitus (Fasting Plasma Glucose > 126 mg/dL and/or HbA1C >6.5%);
Distal symmetric pain in lower extremities with duration of more than 3 months;
Presence of either numbness or at least 1 sensory disturbance (increased or decreased sensitivity) in the feet.
Spontaneous pain with intensity of ≥ 4 on 0-10 Numerical Rating Scale (NRS).

Who cannot join

Not giving consent to participate in the study;
Unable to complete self-report pain questionnaire;
History of moderate to severe renal or liver failure;
History of other central or peripheral neurologic disorders;
History of cardiac arrhythmias;
Contraindication to intravenous lidocaine;
Pregnancy or lactation.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine/Barnes Jewish Hospital
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Predicting Individual Response to Analgesic Treatment in Painful Diabetic Neuropathy

Read the detailed description

Diabetic peripheral neuropathy [DPN] is caused by diabetes-related metabolic damage to the sensory nervous system. It affects more than 3 million Americans and is leading cause of nerve damage-associated pain worldwide. Currently approved drugs such as gabapentin, pregabalin, and duloxetine provide pain relief only in 1 out of 4 or 5 people with DPN, pointing to a great need to identify effective therapy for these patients. Recent literature suggests that certain methods of assessing sensory nerve function in neuropathic pain patients may provide prediction to individual analgesic response; however, no placebo-controlled studies have been performed with the primary goal of identifying treatment response predictors in DPN.

We propose in this study to examine whether sensory testing to determine mechanical pain threshold [MPT] or heat pain threshold [HPT] will predict the subject's response to IV lidocaine analgesic therapy. We hypothesize that people with painful DPN who have high MPT or HPT are more likely to respond to lidocaine treatment. This is a prospective, double blind, placebo-controlled study with the primary objective of determining whether the results from the sensory testing predict the response to systemic lidocaine in patients with painful DPN.

Consented subjects will attend a screening visit and two intervention visits, during which they will undergo sensory testing and receive intravenous lidocaine or placebo infusion in a cross-over design. At enrollment, each patient will be assigned a study number, which will match a previously prepared computer-generated list of randomization numbers to determine the sequence of interventions: lidocaine and then placebo, or vice versa. An unblinded research nurse coordinator will be assigned to match the study number with randomized treatment sequence, and this person will prepare the study medications, which will look identical. This research nurse coordinator will not be involved at any stage at patient assessment or data analysis. The participants and all other study personnel will be blinded to the treatment allocation.

Conditions: Diabetes, Peripheral Neuropathy, Pain
Being tested: lidocaine, Placebo
Medical subject headings: Diabetes Mellitus, Peripheral Nervous System Diseases, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lidocaineDrug
lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.
PlaceboDrug
Normal saline, approved for hypovolemia, and homeostasis.

Study groups in NCT02363803
Study group	Role	What they receive
Normal saline infusion then lidocaine infusion	Placebo comparator	Intravenous infusion of normal saline over a 40 minute period. second intervention: Intravenous infusion of lidocaine [5mg/kg] over a 40 minute period. Receives: Drug: lidocaine; Drug: Placebo
Lidocaine infusion, then normal saline infusion	Active comparator	Intravenous infusion of lidocaine [5mg/kg] over a 40 minute period. second intervention: Intravenous infusion of normal saline over a 40 minute period. Receives: Drug: lidocaine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Spontaneous Pain at 60-120 Minutes After Lidocaine Infusion Initiated (Assessed on 0-10 NRS)
Spontaneous pain will be assessed on numerical rating scale NRS (0= no pain, 10=worst pain imaginable) prior to infusion and then repeatedly for 120 minutes. The outcome measure will use the average of pain intensity measured at timepoints in the 60-120 min range after beginning of infusion. The mean %change in pain (from baseline) will be compared between lidocaine and placebo arms.
Measured: Baseline compared to 60-120 minutes after starting the infusion

Secondary outcomes (4)

Evoked Mechanical and Thermal Sensation at Baseline and 60 Minutes After Infusion Initiation.
Thermal and mechanical responses will be assessed at baseline and 60 minutes after infusions. Evoked intensities measured on a 0-10 sensory scale, where 5 is normal sensation, a number lower than 5 is reduced sensation and a number higher than 5 is greater sensation.
Measured: - 60 minutes (baseline) and + 60 minutes of initiating infusion
NPSI (Neuropathic Pain Symptom Inventory) Descriptors of Pain at Baseline and 60 Min After Infusion
NPSI pain descriptors will be assessed prior to infusion of placebo and lidocaine (baseline) and again at 60 minutes post-infusion. Descriptors are expressed on a 0-10 scale; 0-minimum (least), and 10 maximum (worst) score.
Measured: Baseline to 60 minutes of initiating infusion
Change in Spontaneous Pain Intensity as a Function of Baseline MPT
Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at 60-120 minutes (averaged) from the study drug infusion. The slopes (Pearson coefficients) of the correlation obtained from lidocaine vs. placebo will be compared.
Measured: baseline to 60-120 minutes after starting the infusion
Change in Spontaneous Pain Intensity as a Function of Baseline HPT
Correlation between Heat Pain Threshold (HPT in degrees Celsius) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at 60-120 minutes (averaged) from the study drug infusion. The slopes (Pearson coefficients) of the correlation obtained from lidocaine vs. placebo will be compared.
Measured: Baseline to 60-120 minutes after starting the infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201517 Oct 2018

First posted16 Feb 2015 (estimated)
Study startFeb 2015
Primary completion17 Oct 2018
Study completion17 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
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: Crossover
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02363803
Sponsor's protocol ID: 201412073
Status last verified: Nov 2019
First submitted: 3 Feb 2015
Last updated: 15 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predicting Individual Response to Analgesic Treatment in Painful Diabetic Neuropathy
ClinicalTrials.gov ID: NCT02363803
Acronym / sponsor ID: 201412073
Conditions: Diabetes, Peripheral Neuropathy, Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: Feb 2015 (actual)
Primary completion: 17 Oct 2018 (actual)
Study completion: 17 Oct 2018 (actual)
First posted: 16 Feb 2015 (estimated)
Results: Posted 30 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Normal saline infusion then lidocaine infusion	Placebo comparator	Drug: lidocaine, Drug: PlaceboIntravenous infusion of normal saline over a 40 minute period. second intervention: Intravenous infusion of lidocaine [5mg/kg] over a 40 minute period.
Lidocaine infusion, then normal saline infusion	Active comparator	Drug: lidocaine, Drug: PlaceboIntravenous infusion of lidocaine [5mg/kg] over a 40 minute period. second intervention: Intravenous infusion of normal saline over a 40 minute period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age ≥18;
Diagnosis of Diabetes Mellitus (Fasting Plasma Glucose > 126 mg/dL and/or HbA1C >6.5%);
Distal symmetric pain in lower extremities with duration of more than 3 months;
Presence of either numbness or at least 1 sensory disturbance (increased or decreased sensitivity) in the feet.
Spontaneous pain with intensity of ≥ 4 on 0-10 Numerical Rating Scale (NRS).

Key exclusion criteria (7 listed)

Not giving consent to participate in the study;
Unable to complete self-report pain questionnaire;
History of moderate to severe renal or liver failure;
History of other central or peripheral neurologic disorders;
History of cardiac arrhythmias;

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
lidocainelidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.	Drug	Lidocaine infusion, then normal saline infusion, Normal saline infusion then lidocaine infusion
PlaceboNormal saline, approved for hypovolemia, and homeostasis.	Drug	Lidocaine infusion, then normal saline infusion, Normal saline infusion then lidocaine infusion

Primary outcome

Change in Spontaneous Pain at 60-120 Minutes After Lidocaine Infusion Initiated (Assessed on 0-10 NRS)
Time frame: Baseline compared to 60-120 minutes after starting the infusion
Spontaneous pain will be assessed on numerical rating scale NRS (0= no pain, 10=worst pain imaginable) prior to infusion and then repeatedly for 120 minutes. The outcome measure will use the average of pain intensity measured at timepoints in the 60-120 min range after beginning of infusion. The mean %change in pain (from baseline) will be compared between lidocaine and placebo arms.

4 secondary outcomes

Evoked Mechanical and Thermal Sensation at Baseline and 60 Minutes After Infusion Initiation.
Time frame: - 60 minutes (baseline) and + 60 minutes of initiating infusion
NPSI (Neuropathic Pain Symptom Inventory) Descriptors of Pain at Baseline and 60 Min After Infusion
Time frame: Baseline to 60 minutes of initiating infusion
Change in Spontaneous Pain Intensity as a Function of Baseline MPT
Time frame: baseline to 60-120 minutes after starting the infusion
Change in Spontaneous Pain Intensity as a Function of Baseline HPT
Time frame: Baseline to 60-120 minutes after starting the infusion

Results and safety

Results posted to the registry on 30 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saline First, Then Lidocaine	17	17
Lidocaine First, Then Saline	17	17

Primary outcome: Change in Spontaneous Pain at 60-120 Minutes After Lidocaine Infusion Initiated (Assessed on 0-10 NRS)

Time frame: Baseline compared to 60-120 minutes after starting the infusion. Mean (Standard Deviation). Unit: percentage of pain change from baseline

Measure	Normal Saline Infusion n = 31	Lidocaine Infusion n = 31
Value	33 (46)	51 (40)

Normal Saline Infusion vs Lidocaine Infusion: p = 0.03, t-test, 2 sided

Population analysed: Participants who completed both infusions and had non-zero pain scores at the start of each infusion.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 0-120 minutes after infusion initiation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Saline Infusion	0 of 33 (0%)	11 of 33 (33.3%)	0 of 33
Lidocaine Infusion	0 of 34 (0%)	13 of 34 (38.2%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Diabetes

Active, not recruitingPhase 3
Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
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RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection

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.

Simon Haroutounian, PhD principal investigator

Department of Anesthesiology, WUSTL

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing lidocaine in people with Diabetes and Peripheral Neuropathy, run by Washington University School of Medicine at 1 site in United States.

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 5 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 15 Nov 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 30 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Spontaneous Pain at 60-120 Minutes After Lidocaine Infusion Initiated (Assessed on 0-10 NRS) (time frame: Baseline compared to 60-120 minutes after starting the infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02363803.

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 15 Nov 2019.