Foot Ulcer, DiabeticADA NPWTNCT02308800
Negative Pressure Wound Therapy as a Drug Delivery System (ADANPWT)
A study testing Quantum™ Therapy - NPWT with Prontosan and Quantum™ Therapy in people with Foot Ulcer, Diabetic, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound therapy with continuous irrigation and negative pressure wound therapy without irrigation. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- Quantum™ Therapy - NPWT with Prontosan and Quantum™ Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2017
- 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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes mellitus
- Men/women ≥21 years old
- Foot or ankle wounds sized 5 cm2 -100 cm2
- ABI≥0.5 or toe pressures >30 mmHg
Who cannot join
- Active Charcot arthropathy
- Unable to use NPWT at home
- Untreated bone or soft tissue infection
- Unable to keep research appointments
- Active alcohol or substance abuse (> 14 drinks per week over the last 3 months) or substance abuse (current use of cocaine, heroine or methamphetamine or if drug or alcohol use will interfere with follow up visits in foot clinic in the opinion of the investigator)
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center
Dallas, Texas, 75390-9132
About this study
Official title: Negative Pressure Wound Therapy as a Drug Delivery System
The investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound therapy with continuous irrigation and negative pressure wound therapy without irrigation.
The investigators will enroll 150 patients from two centers: The University of Texas Southwestern University Hospital and Parkland Hospital. The investigators will screen and enroll patients with wounds in the inpatient setting. Patients will randomized to receive traditional NPWT or NPWT with continuous irrigation while they are hospitalized. The average hospitalization for patents that receive NPWT is 13.3 days. Patients that do not have their wound surgically closed during hospitalization will be discharged with negative pressure wound therapy without irrigation for up to a total of four weeks of therapy. After discharge from the hospital, subjects will be seen twice weekly by home health, and the investigators will evaluate subjects in clinic every 7 days (±7 days) for a total of 16-week period or until the wound heals.
Read the detailed description
Screening Procedures
- Review and sign the Informed Consent and HIPAA Authorization
- The study doctor will review the inclusion and exclusion criteria
- Demographics (such as age, gender, race or ethnicity)
- Sitting blood pressure and pulse at admission
- Collection of Height and weight at admission
- Collection of the medical and surgical history
- Collection of the history of the wound
- Wound assessment(s) - wound etiology, wound history, location of study wound and infection assessment
- Hyperspectral imaging within 30 days of screening
- Vascular/Neurological evaluation - we will do various tests and measurements to assess the sensation (feeling) and circulation (blood flow) in the subject's feet and lower legs. To assess the sensation, we will do a monofilament sensory test and a vibration threshold perception test on the study foot. We will calculate the neuropathy disability score of both feet. To assess circulation, we will record Skin Perfusion Pressures in the study foot using a Sensilase System (Vasamed, Eden Prairie, MN) within 30 days of screening. We will calculate the ankle brachial index (ABI) at screening and collect available arterial doppler data from the medical record within 6 months of screening. None of these tests are invasive (using needles), uncomfortable or have risks greater than standard care.
- Results of standard-of-care laboratory tests including a white blood cell count, blood chemistry (tests to see how well organs, such as the liver and kidneys are working), glycated hemoglobin, albumin, prealbumin, erythrocyte sedimentation rate, C-reactive protein and blood glucose. Results of a serum pregnancy test (standard care for women of child-bearing potential as part of pre-op labs) will also be collected. Collection of a list of the subject's current antibiotics
- We will provide the SF-36 Questionnaire and other patient-reported outcomes questionnaires and collect them while subjects are inpatient.
This visit will last about 2 hours.
If you qualify for the study, you will participate in the following procedures:
Group Assignment
If the researchers believe the subject can take part in this study, s/he will be assigned randomly (like a flip of a coin) to receive one of the following therapies:
- Negative Pressure Wound Therapy with Irrigation
- Negative Pressure Wound Therapy without Irrigation
The group is assigned randomly (like flipping a coin). The sponsor or researchers do not know in advance what group assignment each subject will receive. Neither the subject nor the researchers will be allowed to choose which group s/he is assigned to.
Study Intervention
The subject will receive either:
- Quantum™+Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with Prontosan®, or
- Quantum™(NPWT) -Negative Pressure Wound Therapy (without Prontosan®)
Assigned therapy will continue in the hospital until the physician determines that the wound is ready for closure. If the subject's wound is healing, study therapy will be discontinued and standard dressings will be applied. If surgical closure is needed, the subject will return to the Operating Room for a procedure to close the wound.
If the wound is not ready for closure during the hospital stay, subjects will continue NPWT at home. NPWT at home will be without irrigation.
Procedures and Evaluations during the Research The study therapy will only be given while the subject is in the hospital. If the subject's wound is not ready for closure during the hospital stay, the subject will continue NPWT at home. NPWT at home will be without irrigation. Once the therapy is stopped s/he will continue to be followed by the study doctor. After the subject is released from the hospital s/he will need to see the study doctor during regular post-operative visits. The study doctor will continue to check the wound. If the wound closes, s/he will see the study doctor 30 days later to have the closed wound checked.
Day of First Surgery:
- 3D images after the surgery with eKare Insight device
- Tissue and bone samples - the doctor will take 2 small samples of tissue from the subject's wound before debridement (removal of dead or unhealthy tissue), and after debridement (clean margins) and 1 sample of bone before debridement in case of bone infection, and these tissue samples will be kept and tested for the amount and type of bacteria that are present (qPCR analysis/laboratory analysis).
- Wound measurements after the surgery
- The study doctor will decide if the subject still qualifies to be in the study
- Randomization (like flipping a coin) to either Quantum™ NPWT with Irrigation or Quantum™ NPWT without Irrigation
- Placement of therapy on the wound
- Collection of current antibiotics
- Collection of adverse event information
Daily Treatments (while in the hospital):
- Collection of current antibiotics
- Collection of adverse event information
This will take about 15 minutes.
Additional Surgery (if needed to remove dead tissue or to close the wound):
- Tissue sample - the doctor will take 2 small samples of tissue from the subject's wound after debridement (clean margin), and these tissue samples will be kept and tested for the amount and type of bacteria that are present (qPCR analysis/laboratory analysis)
- 3D images of the wound after the surgery/debridement at bedside with eKare Insight device if the wound is still open
- Wound measurements after the surgery/debridement at bedside
- Wound closure or placement of therapy on the wound
- Collect current antibiotics
- Collect adverse event information
If the subject's wound is not closed upon hospital discharge, NPWT will continue at home without irrigation.
Home Health Visits If the subject continues to receive NPWT after hospital discharge, the subject will be seen twice weekly by a home health nurse for dressing changes. The home health nurse will collect sitting blood pressure and pulse rate. Amount, type and character of drainage will be documented, as well as any adverse events and changes to concomitant medications. Offloading will be reapplied after dressing changes.
Follow-Up Visits per standard of care (after therapy has stopped):
- Dressing change / removal / Offloading
- Wound measurements and infection assessment
- Results of standard-of-care laboratory tests including a white blood cell count, blood chemistry (tests to see how well organs, such as the liver and kidneys are working), glycated hemoglobin, albumin, prealbumin, erythrocyte sedimentation rate, C-reactive protein and blood glucose.
- 3D image of the wound with eKare device (if indicated, if the wound is still open)
- Collection of current antibiotics
- Collection of adverse event information
These visits will take about 30 minutes.
End of Study - Wound Closure Follow-up Visit (30 days +/-7 days after your wound closes, if it closes within 12 weeks from Day of first surgery) or Week 16:
- Closed wound assessment
- For subjects whose wound has not closed: 3D images of the wound with eKare device Return to standard care
- Collection of current antibiotics
- Collection of adverse event information
- SF-36 Questionnaire and other patient-reported outcomes questionnaires
This visit will take about 30 minutes.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- Quantum™ Therapy - NPWT with Prontosan, Quantum™ Therapy
- Keywords
- diabetic foot ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantum™ Therapy - NPWT with ProntosanDevice
Negative pressure wound therapy with Prontosan irrigation.
Quantum™ TherapyDevice
Negative pressure wound therapy without irrigation.
| Study group | Role | What they receive |
|---|---|---|
| Quantum™ Therapy/NPWT with Prontosan | Active comparator | Quantum™ Negative Pressure Wound Therapy with Prontosan irrigant. Receives: Device: Quantum™ Therapy - NPWT with Prontosan |
| Quantum™ Therapy | Active comparator | Quantum™ Negative Pressure Wound Therapy without irrigant. Receives: Device: Quantum™ Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare clinical outcomes (time to wound healing, number of surgeries) with Negative Pressure Wound Therapy with irrigation and Negative Pressure Wound Therapy without irrigation.
The investigators expect that patients treated with NPWT with irrigation will a have higher proportions of wounds that heal, fewer surgeries, and faster wound healing trajectories when compared to patients treated with traditional NPWT without irrigation.
Measured: Up to 12 weeks
Secondary outcomes (1)
Compare quantitative cultures (bacterial load as measured by qPCR) and number of clinical infections in patients treated with NPWT with irrigation compared to conventional NPWT.
The investigators expect that patients treated with NPWT and irrigation will have a significantly lower bacterial load, and fewer and less severe clinical infections.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence A Lavery, DPM, MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308800
- Sponsor's protocol ID
- 092014-016
- Acronym
- ADA NPWT
- Status last verified
- Jan 2019
- First submitted
- 7 Nov 2014
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Wound Therapy as a Drug Delivery System
- ClinicalTrials.gov ID
- NCT02308800
- Acronym / sponsor ID
- ADA NPWT / 092014-016
- Conditions
- Foot Ulcer, Diabetic
- Keywords
- diabetic foot ulcer
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Dec 2014 (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 investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound therapy with continuous irrigation and negative pressure wound therapy without irrigation.
The investigators will enroll 150 patients from two centers: The University of Texas Southwestern University Hospital and Parkland Hospital. The investigators will screen and enroll patients with wounds in the inpatient setting. Patients will randomized to receive traditional NPWT or NPWT with continuous irrigation while they are hospitalized. The average hospitalization for patents that receive NPWT is 13.3 days. Patients that do not have their wound surgically closed during hospitalization will be discharged with negative pressure wound therapy without irrigation for up to a total of four weeks of therapy. After discharge from the hospital, subjects will be seen twice weekly by home health, and the investigators will evaluate subjects in clinic every 7 days (±7 days) for a total of 16-week period or until the wound heals.
Detailed description
Screening Procedures
- Review and sign the Informed Consent and HIPAA Authorization
- The study doctor will review the inclusion and exclusion criteria
- Demographics (such as age, gender, race or ethnicity)
- Sitting blood pressure and pulse at admission
- Collection of Height and weight at admission
- Collection of the medical and surgical history
- Collection of the history of the wound
- Wound assessment(s) - wound etiology, wound history, location of study wound and infection assessment
- Hyperspectral imaging within 30 days of screening
- Vascular/Neurological evaluation - we will do various tests and measurements to assess the sensation (feeling) and circulation (blood flow) in the subject's feet and lower legs. To assess the sensation, we will do a monofilament sensory test and a vibration threshold perception test on the study foot. We will calculate the neuropathy disability score of both feet. To assess circulation, we will record Skin Perfusion Pressures in the study foot using a Sensilase System (Vasamed, Eden Prairie, MN) within 30 days of screening. We will calculate the ankle brachial index (ABI) at screening and collect available arterial doppler data from the medical record within 6 months of screening. None of these tests are invasive (using needles), uncomfortable or have risks greater than standard care.
- Results of standard-of-care laboratory tests including a white blood cell count, blood chemistry (tests to see how well organs, such as the liver and kidneys are working), glycated hemoglobin, albumin, prealbumin, erythrocyte sedimentation rate, C-reactive protein and blood glucose. Results of a serum pregnancy test (standard care for women of child-bearing potential as part of pre-op labs) will also be collected. Collection of a list of the subject's current antibiotics
- We will provide the SF-36 Questionnaire and other patient-reported outcomes questionnaires and collect them while subjects are inpatient.
This visit will last about 2 hours.
If you qualify for the study, you will participate in the following procedures:
Group Assignment
If the researchers believe the subject can take part in this study, s/he will be assigned randomly (like a flip of a coin) to receive one of the following therapies:
- Negative Pressure Wound Therapy with Irrigation
- Negative Pressure Wound Therapy without Irrigation
The group is assigned randomly (like flipping a coin). The sponsor or researchers do not know in advance what group assignment each subject will receive. Neither the subject nor the researchers will be allowed to choose which group s/he is assigned to.
Study Intervention
The subject will receive either:
- Quantum™+Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with Prontosan®, or
- Quantum™(NPWT) -Negative Pressure Wound Therapy (without Prontosan®)
Assigned therapy will continue in the hospital until the physician determines that the wound is ready for closure. If the subject's wound is healing, study therapy will be discontinued and standard dressings will be applied. If surgical closure is needed, the subject will return to the Operating Room for a procedure to close the wound.
If the wound is not ready for closure during the hospital stay, subjects will continue NPWT at home. NPWT at home will be without irrigation.
Procedures and Evaluations during the Research The study therapy will only be given while the subject is in the hospital. If the subject's wound is not ready for closure during the hospital stay, the subject will continue NPWT at home. NPWT at home will be without irrigation. Once the therapy is stopped s/he will continue to be followed by the study doctor. After the subject is released from the hospital s/he will need to see the study doctor during regular post-operative visits. The study doctor will continue to check the wound. If the wound closes, s/he will see the study doctor 30 days later to have the closed wound checked.
Day of First Surgery:
- 3D images after the surgery with eKare Insight device
- Tissue and bone samples - the doctor will take 2 small samples of tissue from the subject's wound before debridement (removal of dead or unhealthy tissue), and after debridement (clean margins) and 1 sample of bone before debridement in case of bone infection, and these tissue samples will be kept and tested for the amount and type of bacteria that are present (qPCR analysis/laboratory analysis).
- Wound measurements after the surgery
- The study doctor will decide if the subject still qualifies to be in the study
- Randomization (like flipping a coin) to either Quantum™ NPWT with Irrigation or Quantum™ NPWT without Irrigation
- Placement of therapy on the wound
- Collection of current antibiotics
- Collection of adverse event information
Daily Treatments (while in the hospital):
- Collection of current antibiotics
- Collection of adverse event information
This will take about 15 minutes.
Additional Surgery (if needed to remove dead tissue or to close the wound):
- Tissue sample - the doctor will take 2 small samples of tissue from the subject's wound after debridement (clean margin), and these tissue samples will be kept and tested for the amount and type of bacteria that are present (qPCR analysis/laboratory analysis)
- 3D images of the wound after the surgery/debridement at bedside with eKare Insight device if the wound is still open
- Wound measurements after the surgery/debridement at bedside
- Wound closure or placement of therapy on the wound
- Collect current antibiotics
- Collect adverse event information
If the subject's wound is not closed upon hospital discharge, NPWT will continue at home without irrigation.
Home Health Visits If the subject continues to receive NPWT after hospital discharge, the subject will be seen twice weekly by a home health nurse for dressing changes. The home health nurse will collect sitting blood pressure and pulse rate. Amount, type and character of drainage will be documented, as well as any adverse events and changes to concomitant medications. Offloading will be reapplied after dressing changes.
Follow-Up Visits per standard of care (after therapy has stopped):
- Dressing change / removal / Offloading
- Wound measurements and infection assessment
- Results of standard-of-care laboratory tests including a white blood cell count, blood chemistry (tests to see how well organs, such as the liver and kidneys are working), glycated hemoglobin, albumin, prealbumin, erythrocyte sedimentation rate, C-reactive protein and blood glucose.
- 3D image of the wound with eKare device (if indicated, if the wound is still open)
- Collection of current antibiotics
- Collection of adverse event information
These visits will take about 30 minutes.
End of Study - Wound Closure Follow-up Visit (30 days +/-7 days after your wound closes, if it closes within 12 weeks from Day of first surgery) or Week 16:
- Closed wound assessment
- For subjects whose wound has not closed: 3D images of the wound with eKare device Return to standard care
- Collection of current antibiotics
- Collection of adverse event information
- SF-36 Questionnaire and other patient-reported outcomes questionnaires
This visit will take about 30 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quantum™ Therapy/NPWT with Prontosan | Active comparator | Device: Quantum™ Therapy - NPWT with ProntosanQuantum™ Negative Pressure Wound Therapy with Prontosan irrigant. |
| Quantum™ Therapy | Active comparator | Device: Quantum™ TherapyQuantum™ Negative Pressure Wound Therapy without irrigant. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of diabetes mellitus
- Men/women ≥21 years old
- Foot or ankle wounds sized 5 cm2 -100 cm2
- ABI≥0.5 or toe pressures >30 mmHg
Key exclusion criteria (5 listed)
- Active Charcot arthropathy
- Unable to use NPWT at home
- Untreated bone or soft tissue infection
- Unable to keep research appointments
- Active alcohol or substance abuse (> 14 drinks per week over the last 3 months) or substance abuse (current use of cocaine, heroine or methamphetamine or if drug or alcohol use will interfere with follow up visits in foot clinic in the opinion of the investigator)
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 |
|---|---|---|
| Quantum™ Therapy - NPWT with ProntosanNegative pressure wound therapy with Prontosan irrigation. | Device | Quantum™ Therapy/NPWT with Prontosan |
| Quantum™ TherapyNegative pressure wound therapy without irrigation. | Device | Quantum™ Therapy |
Primary outcome
Compare clinical outcomes (time to wound healing, number of surgeries) with Negative Pressure Wound Therapy with irrigation and Negative Pressure Wound Therapy without irrigation.
Time frame: Up to 12 weeks
The investigators expect that patients treated with NPWT with irrigation will a have higher proportions of wounds that heal, fewer surgeries, and faster wound healing trajectories when compared to patients treated with traditional NPWT without irrigation.
1 secondary outcome
Compare quantitative cultures (bacterial load as measured by qPCR) and number of clinical infections in patients treated with NPWT with irrigation compared to conventional NPWT.
Time frame: Up to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Foot Ulcer, Diabetic
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
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 Quantum™ Therapy - NPWT with Prontosan and Quantum™ Therapy in people with Foot Ulcer, Diabetic, 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 22 Jan 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Compare clinical outcomes (time to wound healing, number of surgeries) with Negative Pressure Wound Therapy with irrigation and Negative Pressure Wound Therapy without irrigation. (time frame: Up to 12 weeks). 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 22 Jan 2019; AzTrials last refreshed its copy on 6 Nov 2026.