Diabetic Peripheral NeuropathyNCT02337218
Electrical Stimulation for Improving Balance in Diabetes
A study testing SENSUS Pain Management System in people with Diabetic Peripheral Neuropathy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a double-blind randomized clinical trial. Both patients and the podiatrist that will evaluate and monitor study patients will be blinded to electrical stimulation application. The manufacturer of the units will be asked to not inform which patient received which unit. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- SENSUS Pain Management System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Mar 2017
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women (non pregnant) 18 years old or above
- Diagnosed for Diabetes Mellitus (type 2)* and ADA criteria Diabetes
- Evidence of peripheral neuropathy on neurologic examination
- Identified by our clinical staff examination and based on the criteria explained in -ADA statement
- Agreed to participate in this study and comply with instruction
Who cannot join
- Amputation and active ulcers or infection
- Cognitive deficits
- MMSE score of 24 or lower
- Unable to stand for more than 5 minutes (including symptomatic orthostatic hypotension or pain)
- Any clinically significant orthopedic, muscular, or peripheral vascular disorders that affect balance
- Alcohol or substance abuse within 6 months or major psychiatric disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
About this study
This is a double-blind randomized clinical trial. Both patients and the podiatrist that will evaluate and monitor study patients will be blinded to electrical stimulation application. The manufacturer of the units will be asked to not inform which patient received which unit. Each unit will be coded with a unique identification number, and the manufacturer units revealed their status, placebo or electric stimulation, only at the end of data collection for the last patient. Subsequently, the investigators could match the status of the identification numbers with the corresponding units to start analyzing the data. Patients that receive an activated electrical stimulation unit will receive a standard dose of 50 volts as described above.
The investigator will enroll a cohort of 80 diabetes (type II) patients with peripheral neuropathy (see section 6 for sample size justification). The diagnosis of diabetes mellitus will be based on World Health Organization criteria.(World-Health-Organization 1999). The inclusion and exclusion criteria are described in table III. The clinical assessments are described in table IV. The investigator will discuss the study design, duration, and its risks with potential subjects asked to participate. The participant will be provided with a consent form to read at their leisure. The investigator will be available to answer questions or provide more explanation as requested by potential participants and their family.
Read the detailed description
There will be a total of five study visits required for each patient. There will be one scheduled visit for baseline evaluation and four additional visits at 2 weeks, 4 weeks, 6 weeks during treatment and 8 weeks (2 weeks post stopping the treatment). The baseline visit will involve completion of a standardized intake form, which will include pertinent demographics such as age, height, weight, education level, occupation, and comorbidities of the study patient (see Table IV). Several clinical assessments will be performed at baseline as well as at each study visit to evaluate severity of neuropathy and skin perfusion as described in the table IV.
Clinical Assessments Baseline Medical History: This will include: duration and type of diabetes, type of diabetes medication (insulin, oral, combination therapy, diet), previous history of foot ulcers, previous history of falls, amputation (toe, foot), lower extremity bypass, lower extremity angioplasty, Coronary artery bypass surgery, cardiac angioplasty, arthritis, liver disease, osteoporosis, malignancy, and bone tumors. The Kaplan co-morbidity index will be used to record disease severity. The New York Heart Association criteria will be used to classify congestive heart failure, and the National Kidney Foundation Disease Outcomes Quality Initiative Clinical Practice Guidelines for chronic kidney disease to stage kidney disease. Research staff will document all prescription and over-the-counter medications. Research staff will measure height and weight to determine body mass index (BMI).
Baseline Social Factors: Marital status, years of education, type of work, tobacco history (pack years, current smoker, current use of chewing tobacco, previous smoker, no tobacco history), drug history (current, previous history, no drug history), education, occupation, and alcohol history will be assessed.
Screening Test for frailty assessment: Fried Frailty Criteria: Weight loss >10 pounds in preceding year; Grip strength; Low levels of physical activity; 15 foot walk time; Exhaustion[13] Screening for cognitive problem: MMSE score [15] Foot questionnaire and foot exam
Baseline \& each 2- week follow-up (week 2, week 4, week 6, and week 8):
Peripheral Neuropathy: Research staff will evaluate Vibration Perception Threshold (VPT) Testing to evaluate large fiber neuropathy Semmes-Weinstein monofilaments, and the Modified Neuropathy Disability Score. (Armstrong and Lawrence 1998) will be done. Research staff will assess light touch and pressure sensation at nine sites on each foot using 4, 10, 26, and 60 Semmes-Weinstein gram monofilaments. (Diamond, Mueller et al. 1989) The Modified Neuropathy Disability Score is a scored clinical examination that includes Achilles deep tendon reflex, pressure, vibration sensation and temperature sensation in both feet.
Pain: Visual Analogue Scale Gait test: 8 sensors will be attached to the legs and lower back using comfortable straps and will be asked to walk 20 meters on a flat surface, two times. A third 20 meter walk will be performed with an additional distractive cognitive task (counting -1). The 4th test will be fast walking. Walking performance (e.g., speed, cadence, and stability) and spatio-temporal parameters of gait (e.g., velocity, stride time, gait inter-cycle variability, double support, and gait initiation) will be measured.
Balance test: The BalanSensTM kinematic sensor will be attached to the legs and lower back and will be used to measure the variation of subject's center of mass measured by the Romberg protocol including double stance, semi-tandem, and full-tandem tests. Patients will be asked to stand straight, feet together, hands crossed for 30 seconds, 20 seconds, and 15 seconds respectively for double stance test, semi-tendem, and full tandem tests with eyes open and closed.
Baseline and 6 weeks follow-up Activity Monitoring: Spontaneous daily physical activity will be monitored in home environment for 2 days using PAMSysTM Removal log: participants will be asked to note the time off, time on, and reason for removal if the PAMSysTM is removed during the 2 day collection period.
Quality of life questionnaire: SF12 Other assessment Fall log: participant will receive a log and agree to call the study overseer in the event of a fall during the 4 weeks study period.
Other patient information: if it was available patients record including medical history, neurological exam results, and physical examination may be gathered from patient record after authorization of the subject (see form T504a). In addition, subject photograph or video during experiment may be taken after subject's authorization.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- SENSUS Pain Management System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSUS Pain Management SystemDevice
An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA.
| Study group | Role | What they receive |
|---|---|---|
| SENSUS Pain Management System | Active comparator | Electrical stimulation device worn on the leg delivering a dose of 50 volts. Receives: Device: SENSUS Pain Management System |
| SENSUS Pain Management System - Sham | Sham comparator | Electrical stimulation device worn on the leg and programmed to deliver no stimulation. Receives: Device: SENSUS Pain Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Test (BalanSense Device)
Postural control changes will be measured using the BalanSense device in subjects assigned to use the active Electrical Stimulation (intervention group) and subjects assigned to non-functional stimulator (sham group). Balance will be assessed for both groups at baseline and at each follow-up visit, weeks 2, 4, 6 and 8. Static balance and postural compensatory strategy will be assessed using the body worn sensor technology. Measurements taken with eyes closed and eyes open.
Measured: 8 weeks
Peripheral Neuropathy Measured by Vibration Perception Threshold (VPT) Testing
We will evaluate Vibration Perception Threshold (VPT) Testing to evaluate large fiber neuropathy in the feet.
Measured: 8 weeks
Gait Test (LegSys System)
8 sensors will be attached to the legs and lower back using comfortable straps and will be asked to walk 20 meters on a flat surface, two times. A third 20 meter walk will be performed with an additional distractive cognitive task (counting -1). The 4th test will be fast walking. Walking performance (e.g., speed, cadence, and stability) and spatio-temporal parameters of gait (e.g., velocity, stride time, gait inter-cycle variability, double support, and gait initiation) will be measured at weeks 2, 4, 6 and 8.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionMar 2017
- Study completionMar 2017
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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral NeuropathyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry Lavery, University of Texas Southwestern Medical Center
- Investigators
- Lawrence A Lavery, DPM, MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337218
- Sponsor's protocol ID
- 062012-035
- Status last verified
- Jul 2020
- First submitted
- 7 Nov 2014
- Last updated
- 14 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Wrobel JS, Najafi B. Diabetic foot biomechanics and gait dysfunction. J Diabetes Sci Technol. 2010 Jul 1;4(4):833-45. doi: 10.1177/193229681000400411.
PubMed 20663446Thakral G, Kim PJ, LaFontaine J, Menzies R, Najafi B, Lavery LA. Electrical stimulation as an adjunctive treatment of painful and sensory diabetic neuropathy. J Diabetes Sci Technol. 2013 Sep 1;7(5):1202-9. doi: 10.1177/193229681300700510.
PubMed 24124947Najafi B, Crews RT, Wrobel JS. A novel plantar stimulation technology for improving protective sensation and postural control in patients with diabetic peripheral neuropathy: a double-blinded, randomized study. Gerontology. 2013;59(5):473-80. doi: 10.1159/000352072. Epub 2013 Jul 16.
PubMed 23860103Aminian K, Najafi B, Bula C, Leyvraz PF, Robert P. Spatio-temporal parameters of gait measured by an ambulatory system using miniature gyroscopes. J Biomech. 2002 May;35(5):689-99. doi: 10.1016/s0021-9290(02)00008-8.
PubMed 11955509Najafi B, Aminian K, Loew F, Blanc Y, Robert PA. Measurement of stand-sit and sit-stand transitions using a miniature gyroscope and its application in fall risk evaluation in the elderly. IEEE Trans Biomed Eng. 2002 Aug;49(8):843-51. doi: 10.1109/TBME.2002.800763.
PubMed 12148823Najafi B, Horn D, Marclay S, Crews RT, Wu S, Wrobel JS. Assessing postural control and postural control strategy in diabetes patients using innovative and wearable technology. J Diabetes Sci Technol. 2010 Jul 1;4(4):780-91. doi: 10.1177/193229681000400403.
PubMed 20663438
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation for Improving Balance in Diabetes
- ClinicalTrials.gov ID
- NCT02337218
- Acronym / sponsor ID
- 062012-035
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Posted 14 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind randomized clinical trial. Both patients and the podiatrist that will evaluate and monitor study patients will be blinded to electrical stimulation application. The manufacturer of the units will be asked to not inform which patient received which unit. Each unit will be coded with a unique identification number, and the manufacturer units revealed their status, placebo or electric stimulation, only at the end of data collection for the last patient. Subsequently, the investigators could match the status of the identification numbers with the corresponding units to start analyzing the data. Patients that receive an activated electrical stimulation unit will receive a standard dose of 50 volts as described above.
The investigator will enroll a cohort of 80 diabetes (type II) patients with peripheral neuropathy (see section 6 for sample size justification). The diagnosis of diabetes mellitus will be based on World Health Organization criteria.(World-Health-Organization 1999). The inclusion and exclusion criteria are described in table III. The clinical assessments are described in table IV. The investigator will discuss the study design, duration, and its risks with potential subjects asked to participate. The participant will be provided with a consent form to read at their leisure. The investigator will be available to answer questions or provide more explanation as requested by potential participants and their family.
Detailed description
There will be a total of five study visits required for each patient. There will be one scheduled visit for baseline evaluation and four additional visits at 2 weeks, 4 weeks, 6 weeks during treatment and 8 weeks (2 weeks post stopping the treatment). The baseline visit will involve completion of a standardized intake form, which will include pertinent demographics such as age, height, weight, education level, occupation, and comorbidities of the study patient (see Table IV). Several clinical assessments will be performed at baseline as well as at each study visit to evaluate severity of neuropathy and skin perfusion as described in the table IV.
Clinical Assessments Baseline Medical History: This will include: duration and type of diabetes, type of diabetes medication (insulin, oral, combination therapy, diet), previous history of foot ulcers, previous history of falls, amputation (toe, foot), lower extremity bypass, lower extremity angioplasty, Coronary artery bypass surgery, cardiac angioplasty, arthritis, liver disease, osteoporosis, malignancy, and bone tumors. The Kaplan co-morbidity index will be used to record disease severity. The New York Heart Association criteria will be used to classify congestive heart failure, and the National Kidney Foundation Disease Outcomes Quality Initiative Clinical Practice Guidelines for chronic kidney disease to stage kidney disease. Research staff will document all prescription and over-the-counter medications. Research staff will measure height and weight to determine body mass index (BMI).
Baseline Social Factors: Marital status, years of education, type of work, tobacco history (pack years, current smoker, current use of chewing tobacco, previous smoker, no tobacco history), drug history (current, previous history, no drug history), education, occupation, and alcohol history will be assessed.
Screening Test for frailty assessment: Fried Frailty Criteria: Weight loss >10 pounds in preceding year; Grip strength; Low levels of physical activity; 15 foot walk time; Exhaustion[13] Screening for cognitive problem: MMSE score [15] Foot questionnaire and foot exam
Baseline \& each 2- week follow-up (week 2, week 4, week 6, and week 8):
Peripheral Neuropathy: Research staff will evaluate Vibration Perception Threshold (VPT) Testing to evaluate large fiber neuropathy Semmes-Weinstein monofilaments, and the Modified Neuropathy Disability Score. (Armstrong and Lawrence 1998) will be done. Research staff will assess light touch and pressure sensation at nine sites on each foot using 4, 10, 26, and 60 Semmes-Weinstein gram monofilaments. (Diamond, Mueller et al. 1989) The Modified Neuropathy Disability Score is a scored clinical examination that includes Achilles deep tendon reflex, pressure, vibration sensation and temperature sensation in both feet.
Pain: Visual Analogue Scale Gait test: 8 sensors will be attached to the legs and lower back using comfortable straps and will be asked to walk 20 meters on a flat surface, two times. A third 20 meter walk will be performed with an additional distractive cognitive task (counting -1). The 4th test will be fast walking. Walking performance (e.g., speed, cadence, and stability) and spatio-temporal parameters of gait (e.g., velocity, stride time, gait inter-cycle variability, double support, and gait initiation) will be measured.
Balance test: The BalanSensTM kinematic sensor will be attached to the legs and lower back and will be used to measure the variation of subject's center of mass measured by the Romberg protocol including double stance, semi-tandem, and full-tandem tests. Patients will be asked to stand straight, feet together, hands crossed for 30 seconds, 20 seconds, and 15 seconds respectively for double stance test, semi-tendem, and full tandem tests with eyes open and closed.
Baseline and 6 weeks follow-up Activity Monitoring: Spontaneous daily physical activity will be monitored in home environment for 2 days using PAMSysTM Removal log: participants will be asked to note the time off, time on, and reason for removal if the PAMSysTM is removed during the 2 day collection period.
Quality of life questionnaire: SF12 Other assessment Fall log: participant will receive a log and agree to call the study overseer in the event of a fall during the 4 weeks study period.
Other patient information: if it was available patients record including medical history, neurological exam results, and physical examination may be gathered from patient record after authorization of the subject (see form T504a). In addition, subject photograph or video during experiment may be taken after subject's authorization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SENSUS Pain Management System | Active comparator | Device: SENSUS Pain Management SystemElectrical stimulation device worn on the leg delivering a dose of 50 volts. |
| SENSUS Pain Management System - Sham | Sham comparator | Device: SENSUS Pain Management SystemElectrical stimulation device worn on the leg and programmed to deliver no stimulation. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women (non pregnant) 18 years old or above
- Diagnosed for Diabetes Mellitus (type 2)* and ADA criteria Diabetes
- Evidence of peripheral neuropathy on neurologic examination
- Identified by our clinical staff examination and based on the criteria explained in -ADA statement
- Agreed to participate in this study and comply with instruction
Key exclusion criteria (6 listed)
- Amputation and active ulcers or infection
- Cognitive deficits
- MMSE score of 24 or lower
- Unable to stand for more than 5 minutes (including symptomatic orthostatic hypotension or pain)
- Any clinically significant orthopedic, muscular, or peripheral vascular disorders that affect balance
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 |
|---|---|---|
| SENSUS Pain Management SystemAn electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA. | Device | SENSUS Pain Management System, SENSUS Pain Management System - Sham |
Primary outcome
Balance Test (BalanSense Device)
Time frame: 8 weeks
Postural control changes will be measured using the BalanSense device in subjects assigned to use the active Electrical Stimulation (intervention group) and subjects assigned to non-functional stimulator (sham group). Balance will be assessed for both groups at baseline and at each follow-up visit, weeks 2, 4, 6 and 8. Static balance and postural compensatory strategy will be assessed using the body worn sensor technology. Measurements taken with eyes closed and eyes open.
Peripheral Neuropathy Measured by Vibration Perception Threshold (VPT) Testing
Time frame: 8 weeks
We will evaluate Vibration Perception Threshold (VPT) Testing to evaluate large fiber neuropathy in the feet.
Gait Test (LegSys System)
Time frame: 8 weeks
8 sensors will be attached to the legs and lower back using comfortable straps and will be asked to walk 20 meters on a flat surface, two times. A third 20 meter walk will be performed with an additional distractive cognitive task (counting -1). The 4th test will be fast walking. Walking performance (e.g., speed, cadence, and stability) and spatio-temporal parameters of gait (e.g., velocity, stride time, gait inter-cycle variability, double support, and gait initiation) will be measured at weeks 2, 4, 6 and 8.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20663446Wrobel JS, Najafi B. Diabetic foot biomechanics and gait dysfunction. J Diabetes Sci Technol. 2010 Jul 1;4(4):833-45. doi: 10.1177/193229681000400411.
- Background: PubMed 24124947Thakral G, Kim PJ, LaFontaine J, Menzies R, Najafi B, Lavery LA. Electrical stimulation as an adjunctive treatment of painful and sensory diabetic neuropathy. J Diabetes Sci Technol. 2013 Sep 1;7(5):1202-9. doi: 10.1177/193229681300700510.
- Background: PubMed 23860103Najafi B, Crews RT, Wrobel JS. A novel plantar stimulation technology for improving protective sensation and postural control in patients with diabetic peripheral neuropathy: a double-blinded, randomized study. Gerontology. 2013;59(5):473-80. doi: 10.1159/000352072. Epub 2013 Jul 16.
- Background: PubMed 11955509Aminian K, Najafi B, Bula C, Leyvraz PF, Robert P. Spatio-temporal parameters of gait measured by an ambulatory system using miniature gyroscopes. J Biomech. 2002 May;35(5):689-99. doi: 10.1016/s0021-9290(02)00008-8.
- Background: PubMed 12148823Najafi B, Aminian K, Loew F, Blanc Y, Robert PA. Measurement of stand-sit and sit-stand transitions using a miniature gyroscope and its application in fall risk evaluation in the elderly. IEEE Trans Biomed Eng. 2002 Aug;49(8):843-51. doi: 10.1109/TBME.2002.800763.
- Results publication: PubMed 20663438Najafi B, Horn D, Marclay S, Crews RT, Wu S, Wrobel JS. Assessing postural control and postural control strategy in diabetes patients using innovative and wearable technology. J Diabetes Sci Technol. 2010 Jul 1;4(4):780-91. doi: 10.1177/193229681000400403.
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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.
Lawrence A Lavery, DPM, MPH principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENSUS Pain Management System in people with Diabetic Peripheral Neuropathy, run by University of Texas Southwestern Medical Center 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 6 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 14 Aug 2020. 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 14 Aug 2020). 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?
Balance Test (BalanSense Device) (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 NCT02337218, which also lists 6 linked publications.
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 14 Aug 2020.