Nasal FractureNCT04038645
Evaluation of Photobiomodulation on Nasal Fractures
A study testing Experimental group (laser) in people with Nasal Fracture, run by University of Nove de Julho.
Trial summary
Nasal fractures are one of the most incidental of facial traumas. Regression of nasal edema is necessary so that surgical reduction of the fracture can be performed. It is known that photobiomodulation (PBM) reduces pain, edema and modulates inflammation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Fracture
- What is being tested?
- Experimental group (laser)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 15 Oct 2020
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy participants.
- With a maximum of 48 hours after nasal trauma.
Who cannot join
- Patients using anticoagulant medication or use of medication that is anti-inflammatory chronically .
- Patients who report a hypersensitivity reaction to any drug used in the research
- Patients with previous nasal fractures.
About this study
Official title: Evaluation of Photobiomodulation on Nasal Fractures: a Randomized, Controlled, Double-blind Clinical Study
Nasal fractures are one of the most incidental of facial traumas. Regression of nasal edema is necessary so that surgical reduction of the fracture can be performed. It is known that photobiomodulation (PBM) reduces pain, edema and modulates inflammation. Regression of edema in a shorter time may decrease hospitalization time, decreasing hospital costs. However, there are no well-designed clinical studies on this subject. Therefore, the objective of this study will be to evaluate if PBM is able to reduce edema in the region of fractured nasal bones prior to nasal reduction and nasal packing, in order to reduce the patient's ability to go through surgery. Thirty-six patients diagnosed with a (primary) nasal fracture admitted to the Mandaqui Hospital Complex whose trauma occurred in the last 48 hours will be randomly divided into: G1- (control) (n = 18). . G2-Light emitter diode (LED) group (n = 18) - The standard hospital treatment will be performed + LED nasal mask. The main variable will be the edema evaluated by the same researcher and with the same technique. Secondary variables will be pain (visual analogue scale - VAS), temperature, rescue medication count, serum C-reactive protein and systemic inflammatory cytokines. Afterwards, the LED or its placebo will also be applied. The questionnaire to assess the impact of treatment on quality of life will be applied at the baseline and after 8 days. Adverse effects will be recorded and reported. If the data is normal, they will be submitted to Student's t-test. The data will be presented by their means ± standard deviation (SD) and the value of p will be set at 0.05.
Read the detailed description
Nasal fractures are one of the most incidental of facial traumas. Regression of nasal edema is necessary so that surgical reduction of the fracture can be performed. It is known that photobiomodulation (PBM) reduces pain, edema and modulates inflammation. Regression of edema in a shorter time may decrease hospitalization time, decreasing hospital costs. However, there are no well-designed clinical studies on this subject. Therefore, the objective of this study will be to evaluate if PBM is able to reduce edema in the region of fractured nasal bones prior to nasal reduction and nasal packing, in order to reduce the patient's ability to go through surgery. Thirty-six patients diagnosed with a (primary) nasal fracture admitted to the Mandaqui Hospital Complex whose trauma occurred in the last 48 hours will be randomly divided into: G1- (control) (n = 18). The control group will be submitted to the standard hospital treatment: standard drug therapy (50mg diclofenac sodium - 5 days, 8 / 8h orally and 500mg dipyrone - 5 days, 6 / 6h , orally). Tylex 30mg orally will be given as rescue medication. In this group there will be simulation of the use of the mask. G2- LED group (n = 18) - The standard hospital treatment will be performed + LED nasal mask (3 points on each side of the nose), λ = 830nm, radiant exposure of 9.7 Joules J / cm2 for 10 minutes. Treatment will be performed at patient admission (up to 24 hours after nasal trauma), and at intervals explained below, for approximately 08 days after hospital admission. The main variable will be the edema evaluated by the same researcher and with the same technique. Secondary variables will be pain (visual analogue scale - VAS), temperature, rescue medication count, serum C-reactive protein and systemic inflammatory cytokines (TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL- nasal fossa and saliva. All evaluations will be performed at baseline (T0) up to 48 hours after trauma, aiming at equivalence in the inflammatory process, (T1) 96h after trauma and (T2) 192h after trauma. Afterwards, the LED or its placebo will also be applied. The questionnaire to assess the impact of treatment on quality of life will be applied at the baseline and after 8 days. Adverse effects will be recorded and reported. If the data is normal, they will be submitted to Student's t-test. The data will be presented by their means ± SD and the value of p will be set at 0.05.
- Conditions
- Nasal Fracture
- Being tested
- Experimental group (laser), Control group (Placebo)
- Keywords
- Nasal Fracture, Photobiomodulation, Laser, Edema
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group (laser)Other
The patients will receive infrared LEDs in 6 points using a mask developed for the research . The irradiations will be performed with red LED ( wavelength = 660 nm) with output power of 100 milliwatt. During application of the LED both patient and operator will wear goggles.
The red diode laser will be used. The power of the device is 100 mW and the wavelength used was 660nm (± 10nm). The diameter of the fiber optic of the apparatus has 600 μm, therefore a spot (area) of 0.002826cm2. The energy delivered per point is 1 Joule. 10 seconds of application is required. As 6 points are irradiated, the total energy delivered is 6 Joules. The energy density is 354 J / cm2 and the power density would be 35.4 W / cm2. The points will be determined by the same operator, obeying the protocol.
Control group (Placebo)Other
Patients will receive the LED at the same points recommended for the experimental group, but will be off. So that the patient does not identify the sound of activation of the device (beep), it will be recorded, and connected at the time of the application of the laser. The questionnaire to assess the impact of treatment on quality of life will be applied at baseline and after 8 days as well as the evaluation of serum CRP.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (laser) | Active comparator | The patients (n=18) will receive infrared LEDs in 6 points (3 on the right side and 3 on the left side) using a mask developed for the research . The irradiations will be performed with red LED ( wavelength = 660 nm) with output power of 100 milliwatt (mW) . The LED light outputs will be positioned in direct contact with the skin. During application of the LED both patient and operator will wear goggles.
The red diode laser will be used. The power of the device is 100 mW and the wavelength used was 660nm (± 10nm). The diameter of the fiber optic of the apparatus has 600 μm, therefore a spot (area) of 0.002826cm2. The energy delivered per point is 1 Joule. 10 seconds of application is required. As 6 points are irradiated, the total energy delivered is 6 Joules. The energy density is 354 J / cm2 and the power density would be 35.4 W / cm2. The points will be determined by the same operator, obeying the protocol. Receives: Other: Experimental group (laser) |
| Control group (Placebo) | Placebo comparator | The patients (n=18) will receive the LED at the same points recommended for the experimental group, but will be off. So that the patient does not identify the sound of activation of the device (beep), it will be recorded, and connected at the time of the application of the laser. The questionnaire to assess the impact of treatment on quality of life will be applied at baseline and after 8 days (by the same evaluator), as well as the evaluation of serum CRP. Receives: Other: Control group (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema
It will be applied a grading system for evaluating eyelid edema: 0 point, none; 1 point, minimal; 2 points, extending on to the iris; 3 points, covering the iris; 4 points, massive edema with the eyelid swollen shut.
Measured: Throughout study completion on average of one year
Secondary outcomes (8)
pain assessed by Vas
The pain will be assessed by applying a VAS visual analogic scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line with the point that best matches the intensity of pain during the evaluation. Instructions on marking will always be given to the patient by the same operator
Measured: Throughout study completion on average of one year
Oral health related quality of life (OHRQoL) assessed by ohip-14
Oral health related quality of life: using Oral Health Impact Profile (OHIP-14)questionnaire we will assess the impact on HRQOL will be measured. This instrument consists of 14 items arranged in 7 factors: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. The answers are given in a 5-point Likert scale (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always).
Measured: Throughout study completion on average of one year
C-reactive protein (CRP)
After approximately 4 to 24 hours of trauma, CRP serum levels reach peaks up to 1000 times its initial concentration, although it is a nonspecific marker and is closely related to tissue necrosis and inflammatory processes. The collection of 10 ml of peripheral blood will be performed through a specific tube by the nurses of the Mandaqui Hospital Group. This analysis will be performed at baseline and on the last assessment day.
Measured: Throughout study completion on average of one year
temperature
Temperature will be measured locally and systemically. The local measurement was measured using a Safety 1st® digital thermometer (Safety 1st®, "No Touch Forehead", Columbus, USA) in the nasal dorsum, one centimeter below the glabella.
Measured: Throughout study completion on average of one year.
Nasal Obstruction
Nasal Obstruction - To evaluate nose permeability the following methodology will be used, the patient will be asked to numerically choose their sense of obstruction on a scale from zero to ten, zero represents no obstruction of air passage and ten indicates total obstruction. During evaluations the patient will not be allowed to see previous ratings. The patient should point out two numbers indicating that the score will be at an intermediate value. The result will be the average of both values. The value obtained will be multiplied by 10, for ease of comparison.
Measured: Throughout study completion on average of one year.
Bruise
Periorbital bruise will be assessed in each patient by assessing the upper and lower eyelids separately, using a 0 to 4-point scale, Kargi scale, 2003
Measured: Throughout study completion on average of one year.
Salivary cytokines TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL-10
5 ml of saliva sample will be collected in 50 ml tubes. They will be aliquoted (1.2ml) into 2 sterile microtubes and the samples will be stored at -80 ºC until further analysis of cytokines TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL-10 via ELISA.
Measured: Throughout study completion on average of one year.
nasal exudate cytokines TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL-10
Exudate samples will be collected with a paper cone that will be placed in the nasal cavity until resistance is felt. The cones will be placed in one sterile microcentrifuge tube and stored at -80 Celsius degree (ºC) until further analysis of cytokines TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL-10 via ELISA.
Measured: Throughout study completion on average of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Dec 2019 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion15 Oct 2020 (estimated)
Why it stopped: Researcher will no longer conduct the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasal FractureStudies 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
- Model description
- 36 patients will be allocated in the experimental and control groups: G1 - Experimental Group (n = 18 Photobiomodulation PBM) - the treatment will be performed in a conventional manner and the patient will receive laser at low intensity. G2 - Control group (n = 18 -placebo of PBM) - treatment will be performed in a conventional manner and simulation of PBM treatment.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
- Investigators
- Anna Carolina RT Horliana, Phd, Principal investigator, Nove de Julho University (Uninove)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038645
- Sponsor's protocol ID
- Nasal fracture
- Status last verified
- Dec 2019
- First submitted
- 25 Jul 2019
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kargi E, Hosnuter M, Babuccu O, Altunkaya H, Altinyazar C. Effect of steroids on edema, ecchymosis, and intraoperative bleeding in rhinoplasty. Ann Plast Surg. 2003 Dec;51(6):570-4. doi: 10.1097/01.sap.0000095652.35806.c5.
PubMed 14646651Oliveira Sierra S, Melo Deana A, Mesquita Ferrari RA, Maia Albarello P, Bussadori SK, Santos Fernandes KP. Effect of low-level laser therapy on the post-surgical inflammatory process after third molar removal: study protocol for a double-blind randomized controlled trial. Trials. 2013 Nov 6;14:373. doi: 10.1186/1745-6215-14-373.
PubMed 24195796
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Photobiomodulation on Nasal Fractures: a Randomized, Controlled, Double-blind Clinical Study
- ClinicalTrials.gov ID
- NCT04038645
- Acronym / sponsor ID
- Nasal fracture
- Conditions
- Nasal Fracture
- Keywords
- Nasal Fracture, Photobiomodulation, Laser, Edema
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Researcher will no longer conduct the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 31 Jul 2019 (actual)
- 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.
Nasal fractures are one of the most incidental of facial traumas. Regression of nasal edema is necessary so that surgical reduction of the fracture can be performed. It is known that photobiomodulation (PBM) reduces pain, edema and modulates inflammation. Regression of edema in a shorter time may decrease hospitalization time, decreasing hospital costs. However, there are no well-designed clinical studies on this subject. Therefore, the objective of this study will be to evaluate if PBM is able to reduce edema in the region of fractured nasal bones prior to nasal reduction and nasal packing, in order to reduce the patient's ability to go through surgery. Thirty-six patients diagnosed with a (primary) nasal fracture admitted to the Mandaqui Hospital Complex whose trauma occurred in the last 48 hours will be randomly divided into: G1- (control) (n = 18). . G2-Light emitter diode (LED) group (n = 18) - The standard hospital treatment will be performed + LED nasal mask. The main variable will be the edema evaluated by the same researcher and with the same technique. Secondary variables will be pain (visual analogue scale - VAS), temperature, rescue medication count, serum C-reactive protein and systemic inflammatory cytokines. Afterwards, the LED or its placebo will also be applied. The questionnaire to assess the impact of treatment on quality of life will be applied at the baseline and after 8 days. Adverse effects will be recorded and reported. If the data is normal, they will be submitted to Student's t-test. The data will be presented by their means ± standard deviation (SD) and the value of p will be set at 0.05.
Detailed description
Nasal fractures are one of the most incidental of facial traumas. Regression of nasal edema is necessary so that surgical reduction of the fracture can be performed. It is known that photobiomodulation (PBM) reduces pain, edema and modulates inflammation. Regression of edema in a shorter time may decrease hospitalization time, decreasing hospital costs. However, there are no well-designed clinical studies on this subject. Therefore, the objective of this study will be to evaluate if PBM is able to reduce edema in the region of fractured nasal bones prior to nasal reduction and nasal packing, in order to reduce the patient's ability to go through surgery. Thirty-six patients diagnosed with a (primary) nasal fracture admitted to the Mandaqui Hospital Complex whose trauma occurred in the last 48 hours will be randomly divided into: G1- (control) (n = 18). The control group will be submitted to the standard hospital treatment: standard drug therapy (50mg diclofenac sodium - 5 days, 8 / 8h orally and 500mg dipyrone - 5 days, 6 / 6h , orally). Tylex 30mg orally will be given as rescue medication. In this group there will be simulation of the use of the mask. G2- LED group (n = 18) - The standard hospital treatment will be performed + LED nasal mask (3 points on each side of the nose), λ = 830nm, radiant exposure of 9.7 Joules J / cm2 for 10 minutes. Treatment will be performed at patient admission (up to 24 hours after nasal trauma), and at intervals explained below, for approximately 08 days after hospital admission. The main variable will be the edema evaluated by the same researcher and with the same technique. Secondary variables will be pain (visual analogue scale - VAS), temperature, rescue medication count, serum C-reactive protein and systemic inflammatory cytokines (TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL- nasal fossa and saliva. All evaluations will be performed at baseline (T0) up to 48 hours after trauma, aiming at equivalence in the inflammatory process, (T1) 96h after trauma and (T2) 192h after trauma. Afterwards, the LED or its placebo will also be applied. The questionnaire to assess the impact of treatment on quality of life will be applied at the baseline and after 8 days. Adverse effects will be recorded and reported. If the data is normal, they will be submitted to Student's t-test. The data will be presented by their means ± SD and the value of p will be set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 36 patients will be allocated in the experimental and control groups: G1 - Experimental Group (n = 18 Photobiomodulation PBM) - the treatment will be performed in a conventional manner and the patient will receive laser at low intensity. G2 - Control group (n = 18 -placebo of PBM) - treatment will be performed in a conventional manner and simulation of PBM treatment.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (laser) | Active comparator | Other: Experimental group (laser)The patients (n=18) will receive infrared LEDs in 6 points (3 on the right side and 3 on the left side) using a mask developed for the research . The irradiations will be performed with red LED ( wavelength = 660 nm) with output power of 100 milliwatt (mW) . The LED light outputs will be positioned in direct contact with the skin. During application of the LED both patient and operator will wear goggles. The red diode laser will be used. The power of the device is 100 mW and the wavelength used was 660nm (± 10nm). The diameter of the fiber optic of the apparatus has 600 μm, therefore a spot (area) of 0.002826cm2. The energy delivered per point is 1 Joule. 10 seconds of application is required. As 6 points are irradiated, the total energy delivered is 6 Joules. The energy density is 354 J / cm2 and the power density would be 35.4 W / cm2. The points will be determined by the same operator, obeying the protocol. |
| Control group (Placebo) | Placebo comparator | Other: Control group (Placebo)The patients (n=18) will receive the LED at the same points recommended for the experimental group, but will be off. So that the patient does not identify the sound of activation of the device (beep), it will be recorded, and connected at the time of the application of the laser. The questionnaire to assess the impact of treatment on quality of life will be applied at baseline and after 8 days (by the same evaluator), as well as the evaluation of serum CRP. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy participants.
- With a maximum of 48 hours after nasal trauma.
Key exclusion criteria (3 listed)
- Patients using anticoagulant medication or use of medication that is anti-inflammatory chronically .
- Patients who report a hypersensitivity reaction to any drug used in the research
- Patients with previous nasal fractures.
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 |
|---|---|---|
| Experimental group (laser)The patients will receive infrared LEDs in 6 points using a mask developed for the research . The irradiations will be performed with red LED ( wavelength = 660 nm) with output power of 100 milliwatt. During application of the LED both patient and operator will wear goggles. The red diode laser will be used. The power of the device is 100 mW and the wavelength used was 660nm (± 10nm). The diameter of the fiber optic of the apparatus has 600 μm, therefore a spot (area) of 0.002826cm2. The energy delivered per point is 1 Joule. 10 seconds of application is required. As 6 points are irradiated, the total energy delivered is 6 Joules. The energy density is 354 J / cm2 and the power density would be 35.4 W / cm2. The points will be determined by the same operator, obeying the protocol. | Other | Experimental Group (laser) |
| Control group (Placebo)Patients will receive the LED at the same points recommended for the experimental group, but will be off. So that the patient does not identify the sound of activation of the device (beep), it will be recorded, and connected at the time of the application of the laser. The questionnaire to assess the impact of treatment on quality of life will be applied at baseline and after 8 days as well as the evaluation of serum CRP. | Other | Control group (Placebo) |
Primary outcome
Edema
Time frame: Throughout study completion on average of one year
It will be applied a grading system for evaluating eyelid edema: 0 point, none; 1 point, minimal; 2 points, extending on to the iris; 3 points, covering the iris; 4 points, massive edema with the eyelid swollen shut.
8 secondary outcomes
pain assessed by Vas
Time frame: Throughout study completion on average of one year
Oral health related quality of life (OHRQoL) assessed by ohip-14
Time frame: Throughout study completion on average of one year
C-reactive protein (CRP)
Time frame: Throughout study completion on average of one year
temperature
Time frame: Throughout study completion on average of one year.
Nasal Obstruction
Time frame: Throughout study completion on average of one year.
Bruise
Time frame: Throughout study completion on average of one year.
Salivary cytokines TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL-10
Time frame: Throughout study completion on average of one year.
nasal exudate cytokines TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL-10
Time frame: Throughout study completion on average of one year.
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 29 Jun 2023.
- Background: PubMed 14646651Kargi E, Hosnuter M, Babuccu O, Altunkaya H, Altinyazar C. Effect of steroids on edema, ecchymosis, and intraoperative bleeding in rhinoplasty. Ann Plast Surg. 2003 Dec;51(6):570-4. doi: 10.1097/01.sap.0000095652.35806.c5.
- Background: PubMed 24195796Oliveira Sierra S, Melo Deana A, Mesquita Ferrari RA, Maia Albarello P, Bussadori SK, Santos Fernandes KP. Effect of low-level laser therapy on the post-surgical inflammatory process after third molar removal: study protocol for a double-blind randomized controlled trial. Trials. 2013 Nov 6;14:373. doi: 10.1186/1745-6215-14-373.
- Individual participant dataSharing planned: No
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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.
Anna Carolina RT Horliana, Phd principal investigator
Nove de Julho University (Uninove)
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group (laser) in people with Nasal Fracture, run by University of Nove de Julho.
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 2 inclusion and 3 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Edema (time frame: Throughout study completion on average of one year). 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 NCT04038645, which also lists 2 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 29 Jun 2023.