Distal Radius FractureNCT04484584
Complex Decongestive Therapy on Distal Radius Fracture
An observational study of Distal Radius Fracture, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Trauma results in inflammatory reactions accompanied by high protein edema. Trauma can also reduce the carrying capacity of the lymphatic system below normal lymphatic load, leading to exposure of lymphedema. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- complex decongestive therapy
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Mar 2020to 17 Jul 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with distal radius fracture
Who may be able to join
- Over 45 years
- Unilateral distal radius fracture treated with plaster cast
- Begin treatment after (7-10) days after removing the plaster
- At least 50 mL of the volume difference between the upper extremities
- Having signed the consent form
Who cannot join
- Associated ulna fracture
- Pathological fracture
- polytrauma
- Bilateral fractures
- With chronic kidney disease
- The presence of infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi konuk training and research hospital
Istanbul, 34158
About this study
Official title: The Effect of Complex Decongestive Treatment on Edema and Hand Functions in Patients With Distal Radius Fracture
Trauma results in inflammatory reactions accompanied by high protein edema. Trauma can also reduce the carrying capacity of the lymphatic system below normal lymphatic load, leading to exposure of lymphedema. Cellular wastes accumulated in interstitial fields and prolonged exudation period create a physiological problem. It causes the recovery time of tissues to be completed late and the functional gains to be delayed.
The aim of the study is to investigate the effect of Complex decongestive therapy on traumatic edema, pain and functionality.
Read the detailed description
Patients are composed of patients who are referred to the physical medicine and rehabilitation clinic. All patients eligible for the study were informed about treatment and possible risks, and a consent form was signed. Determined evaluations were made to the patients. After 3 weeks of treatment, patients will be invited to the controls and the long-term effects of the treatments will be investigated.
Patients with a diameter difference of more than 50 ml between two extremities and patients without Sudeck Atrophy will be included in the treatment.
The study was planned as a single blind with randomized control. The physiotherapist who performed the treatment received manual lymph drainage therapy training.
The patients were distributed to groups with a computer-based data distribution system. While the patients are sent for treatment, they are directed according to the first assessment. The person who performed the assessment and those who received treatment were planned differently.
The primary purpose of the study was to investigate the long-term effectiveness of complex decongestive therapy on traumatic edema, as well as to evaluate long-term hand functions. Other objectives are to investigate the long-term effects on range of motion, muscle strength, grip strength, pain, and daily living activities.
- Conditions
- Distal Radius Fracture
- Being tested
- complex decongestive therapy
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complex decongestive therapyOther
Manual lymphatic drainage Manuel lymphatic drainage therapeutic technique is used for reducing edema and symptoms related with edema by accelerating lymphatic drainage. The aim of massage along the extremity is to provide fluid drainage.Manuel lymphatic drainage stimulates the internal contraction of lymphatic channels. If interstitial space concentration of protein is reduced, it provides drainage of obstructed lymph fluid from local lymph nodes.
| Study group | Role | What they receive |
|---|---|---|
| Complex Decongestive Therapy Group (CDT) | Complex Decongestive Therapy Group: The treatment was applied by a specialist therapist who received CDT training. The study group rehabilitation and CDT application is 1 hour. CDT Treatment Protocol:
Deep abdominal technique application Neck region CDT application (supraclavicular fossa circular motion-Eflöraj) Circular movements on ipsilateral Axillar lymph nodes Circular movements on bottle neck cubital fossa Front arm bucket pumping pump push MLD application of dorsal and palmar face of the hand to ulnar and radial bundles
Bandage Treatment (Fingers and hand and forearm bandage): Patients can stay for 6-8 hours or until the next day.
Patients can do exercises in bandages. The patient is given home education.
The treatment was made for approximately 30-45 minutes. Patients were given exercise training at home. Orthopedic rehabilitation is the same as the control group. Receives: Other: complex decongestive therapy | |
| Orthopedic Rehabilitation Group (OR) | Orthopedic Rehabilitation Group: The treatment was made for approximately 30-45 minutes. Patients were given exercise training at home.
Orthopedic Rehabilitation Treatment Protocol:
Exercises to be done at 4 to 6 weeks: Wrist NEH (at the pain limit),active exercise,Grasp exercise
Exercises to be done at 6 to 8 weeks: Wrist NEH (at the pain limit),Active assistive / active exercise, Grasp exercise,Supination-pronation exercise. (Opposite baths and classical massage are recommended from orthopedics)
Exercises to be done at 8 to 10 weeks: Stretching exercises,Finger strengthening spring with Digiflex spring, Power web combo hand finger arm amplifier, Msd theraflex hand exercise dough, Theraband flevbar exercise bar.
Exercises to be done at 10 to 12 weeks Wrist strengthening exercises, Resistant exercises to all muscles. Receives: Other: complex decongestive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric test measurement
Volumetric test measurement is more than 50 mL, edema is considered to be present.
Measured: at baseline
Volumetric test measurement
Volumetric test measurement is more than 50 mL, edema is considered to be present.
Measured: 4. week
Michigan Hand Outcomes Questionnarie
The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. The MHQ is scored using a general algorithm. The response categories for one of the questions is reversed and re-coded. For the Pain scale, a higher score indicates more pain. For the other five scales, higher scores indicate better hand performance.
Measured: at baseline
Michigan Hand Outcomes Questionnarie
The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. The MHQ is scored using a general algorithm. The response categories for one of the questions is reversed and re-coded. For the Pain scale, a higher score indicates more pain. For the other five scales, higher scores indicate better hand performance.
Measured: 4. week
Patient Rated Wrist Evaluation
The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales:
Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.
Measured: at baseline
Patient Rated Wrist Evaluation
The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales:
Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.
Measured: 4. week
Quick DASH
Quick DASH measures upper extremity functionality. Quick DASH score calculation is made as disability / symptom score: ([n total score / n] -1) x25. The options are 'no difficulty' 'mild difficulty' 'moderate difficulty' severe difficulty 'and' unable '. 'no difficulty' is zero points and 'unable' is four.
Measured: at baseline
Quick DASH
Quick DASH measures upper extremity functionality. Quick DASH score calculation is made as disability / symptom score: ([n total score / n] -1) x25. The options are 'no difficulty' 'mild difficulty' 'moderate difficulty' severe difficulty 'and' unable '. 'no difficulty' is zero points and 'unable' is four.
Measured: 4. week
Secondary outcomes (4)
Myometer test
Myometer test is an electronic device used to measure muscle strength. It is directly proportional to the result of muscle strength. and the result will increase according to the force. 3 evaluations are made and the average is recorded. According to the manufacturer's specifications, the myometer used has a measurement range of 0 to 30kg with an overload rating to 40kg and an accuracy of ± 0.3kg, and is calibrated to within 0.1kg.
Measured: at baseline
Myometer test
Myometer test is an electronic device used to measure muscle strength. It is directly proportional to the result of muscle strength. and the result will increase according to the force. 3 evaluations are made and the average is recorded. According to the manufacturer's specifications, the myometer used has a measurement range of 0 to 30kg with an overload rating to 40kg and an accuracy of ± 0.3kg, and is calibrated to within 0.1kg.
Measured: 4.week
Dynamometer test
A grip strength dynamometer is useful for testing your hand grip strength. for males (in kg): 45-49 < 34.7 34.7-54.5 > 54.5 50-54 < 32.9 32.9-50.7 > 50.7 55-59 < 30.7 30.7-48.5 > 48.5 60-64 < 30.2 30.2-48.0 > 48.0 65-69 < 28.2 28.2-44.0 > 44.0 70-99 < 21.3 21.3-35.1 > 35.1 for females(in kg): 45-49 < 18.6 18.6-32.4 > 32.4 50-54 < 18.1 18.1-31.9 > 31.9 55-59 < 17.7 17.7-31.5 > 31.5 60-64 < 17.2 17.2-31.0 > 31.0 65-69 < 15.4 15.4-27.2 > 27.2 70-99 < 14.7 14.7-24.5 > 24.5
Measured: at baseline
Dynamometer test
A grip strength dynamometer is useful for testing your hand grip strength. for males (in kg): 45-49 < 34.7 34.7-54.5 > 54.5 50-54 < 32.9 32.9-50.7 > 50.7 55-59 < 30.7 30.7-48.5 > 48.5 60-64 < 30.2 30.2-48.0 > 48.0 65-69 < 28.2 28.2-44.0 > 44.0 70-99 < 21.3 21.3-35.1 > 35.1 for females(in kg): 45-49 < 18.6 18.6-32.4 > 32.4 50-54 < 18.1 18.1-31.9 > 31.9 55-59 < 17.7 17.7-31.5 > 31.5 60-64 < 17.2 17.2-31.0 > 31.0 65-69 < 15.4 15.4-27.2 > 27.2 70-99 < 14.7 14.7-24.5 > 24.5
Measured: 4.week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start17 Mar 2020
- Primary completion17 Jul 2021
- Study completion17 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Distal Radius 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tuba Altun, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- meltem vural, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospitalbanu aydeniz, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospitaltuba Altun, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training HospitalHasan Kerem Alptekin, Study director, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484584
- Sponsor's protocol ID
- Traumatic Edema
- Status last verified
- Aug 2022
- First submitted
- 9 Jul 2020
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Priganc V, Walter JR, Sublett SH. Edema assessment and management practice patterns among hand therapists: Survey research. J Hand Ther. 2020 Jul-Sep;33(3):378-385. doi: 10.1016/j.jht.2019.04.005. Epub 2019 Oct 14.
PubMed 31623957Rohner-Spengler M, Frotzler A, Honigmann P, Babst R. Effective Treatment of Posttraumatic and Postoperative Edema in Patients with Ankle and Hindfoot Fractures: A Randomized Controlled Trial Comparing Multilayer Compression Therapy and Intermittent Impulse Compression with the Standard Treatment with Ice. J Bone Joint Surg Am. 2014 Aug 6;96(15):1263-1271. doi: 10.2106/JBJS.K.00939.
PubMed 25100773Miller LK, Jerosch-Herold C, Shepstone L. Effectiveness of edema management techniques for subacute hand edema: A systematic review. J Hand Ther. 2017 Oct-Dec;30(4):432-446. doi: 10.1016/j.jht.2017.05.011. Epub 2017 Aug 12.
PubMed 28807598
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Complex Decongestive Treatment on Edema and Hand Functions in Patients With Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT04484584
- Acronym / sponsor ID
- Traumatic Edema
- Conditions
- Distal Radius Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 17 Jul 2021 (actual)
- Study completion
- 17 Jul 2021 (actual)
- First posted
- 23 Jul 2020 (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.
Trauma results in inflammatory reactions accompanied by high protein edema. Trauma can also reduce the carrying capacity of the lymphatic system below normal lymphatic load, leading to exposure of lymphedema. Cellular wastes accumulated in interstitial fields and prolonged exudation period create a physiological problem. It causes the recovery time of tissues to be completed late and the functional gains to be delayed.
The aim of the study is to investigate the effect of Complex decongestive therapy on traumatic edema, pain and functionality.
Detailed description
Patients are composed of patients who are referred to the physical medicine and rehabilitation clinic. All patients eligible for the study were informed about treatment and possible risks, and a consent form was signed. Determined evaluations were made to the patients. After 3 weeks of treatment, patients will be invited to the controls and the long-term effects of the treatments will be investigated.
Patients with a diameter difference of more than 50 ml between two extremities and patients without Sudeck Atrophy will be included in the treatment.
The study was planned as a single blind with randomized control. The physiotherapist who performed the treatment received manual lymph drainage therapy training.
The patients were distributed to groups with a computer-based data distribution system. While the patients are sent for treatment, they are directed according to the first assessment. The person who performed the assessment and those who received treatment were planned differently.
The primary purpose of the study was to investigate the long-term effectiveness of complex decongestive therapy on traumatic edema, as well as to evaluate long-term hand functions. Other objectives are to investigate the long-term effects on range of motion, muscle strength, grip strength, pain, and daily living activities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex Decongestive Therapy Group (CDT) | – | Other: complex decongestive therapyComplex Decongestive Therapy Group: The treatment was applied by a specialist therapist who received CDT training. The study group rehabilitation and CDT application is 1 hour. CDT Treatment Protocol: Deep abdominal technique application Neck region CDT application (supraclavicular fossa circular motion-Eflöraj) Circular movements on ipsilateral Axillar lymph nodes Circular movements on bottle neck cubital fossa Front arm bucket pumping pump push MLD application of dorsal and palmar face of the hand to ulnar and radial bundles Bandage Treatment (Fingers and hand and forearm bandage): Patients can stay for 6-8 hours or until the next day. Patients can do exercises in bandages. The patient is given home education. The treatment was made for approximately 30-45 minutes. Patients were given exercise training at home. Orthopedic rehabilitation is the same as the control group. |
| Orthopedic Rehabilitation Group (OR) | – | Other: complex decongestive therapyOrthopedic Rehabilitation Group: The treatment was made for approximately 30-45 minutes. Patients were given exercise training at home. Orthopedic Rehabilitation Treatment Protocol: Exercises to be done at 4 to 6 weeks: Wrist NEH (at the pain limit),active exercise,Grasp exercise Exercises to be done at 6 to 8 weeks: Wrist NEH (at the pain limit),Active assistive / active exercise, Grasp exercise,Supination-pronation exercise. (Opposite baths and classical massage are recommended from orthopedics) Exercises to be done at 8 to 10 weeks: Stretching exercises,Finger strengthening spring with Digiflex spring, Power web combo hand finger arm amplifier, Msd theraflex hand exercise dough, Theraband flevbar exercise bar. Exercises to be done at 10 to 12 weeks Wrist strengthening exercises, Resistant exercises to all muscles. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with distal radius fracture
Key inclusion criteria (5 listed)
- Over 45 years
- Unilateral distal radius fracture treated with plaster cast
- Begin treatment after (7-10) days after removing the plaster
- At least 50 mL of the volume difference between the upper extremities
- Having signed the consent form
Key exclusion criteria (6 listed)
- Associated ulna fracture
- Pathological fracture
- polytrauma
- Bilateral fractures
- With chronic kidney disease
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 |
|---|---|---|
| complex decongestive therapyManual lymphatic drainage Manuel lymphatic drainage therapeutic technique is used for reducing edema and symptoms related with edema by accelerating lymphatic drainage. The aim of massage along the extremity is to provide fluid drainage.Manuel lymphatic drainage stimulates the internal contraction of lymphatic channels. If interstitial space concentration of protein is reduced, it provides drainage of obstructed lymph fluid from local lymph nodes. | Other | Complex Decongestive Therapy Group (CDT), Orthopedic Rehabilitation Group (OR) |
Primary outcome
Volumetric test measurement
Time frame: at baseline
Volumetric test measurement is more than 50 mL, edema is considered to be present.
Volumetric test measurement
Time frame: 4. week
Volumetric test measurement is more than 50 mL, edema is considered to be present.
Michigan Hand Outcomes Questionnarie
Time frame: at baseline
The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. The MHQ is scored using a general algorithm. The response categories for one of the questions is reversed and re-coded. For the Pain scale, a higher score indicates more pain. For the other five scales, higher scores indicate better hand performance.
Michigan Hand Outcomes Questionnarie
Time frame: 4. week
The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. The MHQ is scored using a general algorithm. The response categories for one of the questions is reversed and re-coded. For the Pain scale, a higher score indicates more pain. For the other five scales, higher scores indicate better hand performance.
Patient Rated Wrist Evaluation
Time frame: at baseline
The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales: Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.
Patient Rated Wrist Evaluation
Time frame: 4. week
The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales: Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.
Quick DASH
Time frame: at baseline
Quick DASH measures upper extremity functionality. Quick DASH score calculation is made as disability / symptom score: ([n total score / n] -1) x25. The options are 'no difficulty' 'mild difficulty' 'moderate difficulty' severe difficulty 'and' unable '. 'no difficulty' is zero points and 'unable' is four.
Quick DASH
Time frame: 4. week
Quick DASH measures upper extremity functionality. Quick DASH score calculation is made as disability / symptom score: ([n total score / n] -1) x25. The options are 'no difficulty' 'mild difficulty' 'moderate difficulty' severe difficulty 'and' unable '. 'no difficulty' is zero points and 'unable' is four.
4 secondary outcomes
Myometer test
Time frame: at baseline
Myometer test
Time frame: 4.week
Dynamometer test
Time frame: at baseline
Dynamometer test
Time frame: 4.week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Background: PubMed 31623957Priganc V, Walter JR, Sublett SH. Edema assessment and management practice patterns among hand therapists: Survey research. J Hand Ther. 2020 Jul-Sep;33(3):378-385. doi: 10.1016/j.jht.2019.04.005. Epub 2019 Oct 14.
- Background: PubMed 25100773Rohner-Spengler M, Frotzler A, Honigmann P, Babst R. Effective Treatment of Posttraumatic and Postoperative Edema in Patients with Ankle and Hindfoot Fractures: A Randomized Controlled Trial Comparing Multilayer Compression Therapy and Intermittent Impulse Compression with the Standard Treatment with Ice. J Bone Joint Surg Am. 2014 Aug 6;96(15):1263-1271. doi: 10.2106/JBJS.K.00939.
- Background: PubMed 28807598Miller LK, Jerosch-Herold C, Shepstone L. Effectiveness of edema management techniques for subacute hand edema: A systematic review. J Hand Ther. 2017 Oct-Dec;30(4):432-446. doi: 10.1016/j.jht.2017.05.011. Epub 2017 Aug 12.
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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.
meltem vural principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
banu aydeniz principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
tuba Altun principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fracture, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 16 Aug 2022. 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 Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric test measurement (time frame: at baseline). The study lists 8 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 NCT04484584, which also lists 3 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 16 Aug 2022.