Amputation; Traumatic, Leg, LowerNCT03347682
Turkish Validation of Prosthesis Donning and Doffing Questionnaire
An observational study of Amputation; Traumatic, Leg, Lower, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the Reliability and construct validity of the Turkish version of the Prosthesis donning and doffing questionnaire in transtibial amputees. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputation; Traumatic, Leg, Lower
- What is being tested?
- Satisfaction with Prosthesis -SATPRO, Nottingham Health Profile-NHP and Prosthesis donning and doffing questionnaire
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2017to 30 Jun 2019
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Transtibial amputees aged 18-65 years and using their well fitted prosthesis at least 1 year
Who may be able to join
- Transtibial amputee, who used prosthesis for at least 1 year and had no cognitive disorders.
Who cannot join
- Bilateral amputation or upper extremity amputation
- Amputation levels other than transtibial
- Cognitif impairement
- Presence of neuroma, bony growths, skin lesions, wounds leading unability to use prosthesis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, 34899
About this study
Official title: Reliability and Construct Validity of the Turkish Version of the Prosthesis Donning and Doffing Questionnaire in Transtibial Amputees.
The aim of this study is to investigate the Reliability and construct validity of the Turkish version of the Prosthesis donning and doffing questionnaire in transtibial amputees.
Read the detailed description
Knowing that a socket and suspension system should be donned and doffed few times during the day and night, it is important to measure ease of donning and doffing. Effortless donning and doffing does appear to have a posi- tive effect on satisfaction with a prosthesis. The socket and suspension systems require different methods of don and doff, some of which are time-consuming and necessi- tate more hand strength and cognitive effort than others. The pin/lock suspension needs few re-adjustments of residual limb within the socket so that the pin is fully locked distally. The seal-in system, for example, needs a longer period as first the amputee needs to spray either the inner socket or the seals, and then remove the socket valve and push the limb into the socket and put back the valve. Instruments are available to evaluate socket comfort such as the socket comfort score, yet to the authors' knowledge no instrument has been developed that focuses on donning and doffing quality of prosthesis. The clearer the insight into suspension systems, the easier will be the selection for prosthetist.
There are different questionnaires in the fields of prosthetics and orthotics such as Prosthetic Evaluation Questionnaire (PEQ), Trinity Amputation and Prosthesis Experience Scales (TAPES), Orthotic Prosthetic User's Survey (OPUS), Houghton scale of prosthetic use, and Amputee Body Image Scale (ABIS) However, few of these instruments address donning and doffing of prosthesis. There is no questionnaire in Turkish available to evaluate the donning and doffing procedures of suspension systems. Thus, the aim of this study is to investigate the Reliability and construct validity of the Turkish version of the Prosthesis donning and doffing questionnaire in transtibial amputees.
After obtaining permission from the developers of the Prosthesis donning and doffing questionnaire, the Turkish version of the instrument will be developed. For the translation process, established guidelines for patient reported outcome (PRO) instrument translation and include both forward and backward (reverse) translation of instructions, items, and response options by independent translators; review by bilingual experts; reconciliation of translations; and cognitive testing of the translated instruments, as described by Eremenco et al., 2005 or Reeve et al., 2013 were followed.The necessity of performing a cultural adaptation for the use of the Turkish version among Turkish amputees will be assessed. Level of education part of the manuscript is planned to be changed bacause it doesn't fit the education system in Turkey). After discussions between the study investigators and translators, a Turkish version of the Prosthesis donning and doffing questionnaire that corresponded as closely as possible to the original survey will be produced. Each subject will be asked to complete the Turkish version of the Prosthesis donning and doffing questionnaire twice (1-3 days apart). To evaluate the validity of the Turkish version of the Prosthesis donning and doffing questionnaire, the Nottingham Health Profile(NHP), Satisfaction with Prosthesis -SATPRO surveys will be used.
Satisfaction with the prosthesis has the following subscales: aesthetic satisfaction with the prosthesis, weight satisfaction with the prosthesis and functional satisfaction with the prosthesis. The weight satisfaction subscale has just one item, which is answered with a 5-point Likert-type scale, whereas both aesthetic satisfaction and functional satisfaction with prosthesis have five items, each answeredwith a 5-point Likert-type scale.
The Turkish version of Nottingham Health Profile(NHP), a generic quality of life measurement tool, has been showed to be a valid and reliable outcome measurement. For this reason it will be used to analyse the construct validity of the Prosthesis donning and doffing questionnaire. NHP (translated by Küçükdeveci et a.) includes the following six subdomains: energy level, physical activities, pain, sleep, emotional reaction and social isolation. The sum of the scores of each subdomain equals.12 The SATPro is a 15-item questionnaire that measures general satisfaction with a prosthesis. The Turkish version of the questionnaire, developed by Simsek, was used. Each item on the questionnaire is scored between 0 and 3.
- Conditions
- Amputation; Traumatic, Leg, Lower
- Being tested
- Satisfaction with Prosthesis -SATPRO, Nottingham Health Profile-NHP, Prosthesis donning and doffing questionnaire
- Keywords
- Amputation, prosthesis,psychometrics, questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satisfaction with Prosthesis -SATPROOther
questionnaire 1
Nottingham Health Profile-NHPOther
questionnaire 2
Prosthesis donning and doffing questionnaireOther
questionnaire 3
| Study group | Role | What they receive |
|---|---|---|
| Test group: Transtibial amputees | After translation/retranslation of the Prosthesis donning and doffing questionnaire, transtibial amputees will be asked to complete a quality of life evaluation Nottingham Health Profile-NHP, a satisfaction evaluation Satisfaction with Prosthesis -SATPRO and the Turkish version of the Prosthesis donning and doffing questionnaire twice (1-3 days apart). Receives: Other: Satisfaction with Prosthesis -SATPRO; Other: Nottingham Health Profile-NHP; Other: Prosthesis donning and doffing questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthesis donning and doffing questionnaire
Satisfaction was measured through Prosthesis donning and doffing questionnaire. The total score may be categorized into "low, moderate, and high" as follows-total score ⩽ 2: low; total score = 3 and 4: moderate; and total score ⩾ 5: high. The higher score may be interpreted as higher quality and satisfaction with the donning and doffing.
Measured: Day 0
Prosthesis donning and doffing questionnaire
Satisfaction was measured through Prosthesis donning and doffing questionnaire. The total score may be categorized into "low, moderate, and high" as follows-total score ⩽ 2: low; total score = 3 and 4: moderate; and total score ⩾ 5: high. The higher score may be interpreted as higher quality and satisfaction with the donning and doffing.
Measured: Day 3
Secondary outcomes (4)
Satisfaction with Prosthesis -SATPRO
The questionnaire includes 15 items developed on the basis of the most significant criteria used by the person when selecting a technical aid. Minimum score 0 maximum score 45.
Measured: Day 0
Satisfaction with Prosthesis -SATPRO
The questionnaire includes 15 items developed on the basis of the most significant criteria used by the person when selecting a technical aid. Minimum score 0-maximum score 45.
Measured: Day 3
Nottingham Health Profile
The Nottingham Health Profile is intended for primary health care, to provide a brief indication of a patient's perceived emotional, social and physical health problems. The number of questions answered "yes" in each subgroup is divided by the total number of questions in the same subgroup and the result is multiplied by 100. Each subgroup has a value of between 0 and 100, with 100 points being considered the best general QoL for the calculated subgroup and 0 points being considered as the worst QoL for the same subgroup.
Measured: Day 0
Nottingham Health Profile
The Nottingham Health Profile is intended for primary health care, to provide a brief indication of a patient's perceived emotional, social and physical health problems. The number of questions answered "yes" in each subgroup is divided by the total number of questions in the same subgroup and the result is multiplied by 100. Each subgroup has a value of between 0 and 100, with 100 points being considered the best general QoL for the calculated subgroup and 0 points being considered as the worst QoL for the same subgroup.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Dec 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Amputation; Traumatic, Leg, LowerStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giray Esra, MD, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347682
- Sponsor's protocol ID
- 09.2017.659
- Status last verified
- Oct 2017
- First submitted
- 15 Nov 2017
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang M, Turner-Smith AR, Tanner A, Roberts VC. Clinical investigation of the pressure and shear stress on the trans-tibial stump with a prosthesis. Med Eng Phys. 1998 Apr;20(3):188-98. doi: 10.1016/s1350-4533(98)00013-7.
PubMed 9690489Abu Osman NA, Eshraghi A, Gholizadeh H, Wan Abas WAB, Lechler K. Prosthesis donning and doffing questionnaire: Development and validation. Prosthet Orthot Int. 2017 Dec;41(6):571-578. doi: 10.1177/0309364617690397. Epub 2017 Feb 13.
PubMed 28190376Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.
PubMed 15804318Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.
PubMed 10826123Kuru P, Akyuz G, Yagci I, Giray E. Hypovitaminosis D in widespread pain: its effect on pain perception, quality of life and nerve conduction studies. Rheumatol Int. 2015 Feb;35(2):315-22. doi: 10.1007/s00296-014-3099-7. Epub 2014 Aug 2.
PubMed 25085713Schaffalitzky E, Gallagher P, Maclachlan M, Wegener ST. Developing consensus on important factors associated with lower limb prosthetic prescription and use. Disabil Rehabil. 2012;34(24):2085-94. doi: 10.3109/09638288.2012.671885. Epub 2012 Apr 12.
PubMed 22494367Eshraghi A, Osman NA, Gholizadeh H, Karimi M, Ali S. Pistoning assessment in lower limb prosthetic sockets. Prosthet Orthot Int. 2012 Mar;36(1):15-24. doi: 10.1177/0309364611431625. Epub 2012 Jan 22.
PubMed 22269941
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Construct Validity of the Turkish Version of the Prosthesis Donning and Doffing Questionnaire in Transtibial Amputees.
- ClinicalTrials.gov ID
- NCT03347682
- Acronym / sponsor ID
- 09.2017.659
- Conditions
- Amputation; Traumatic, Leg, Lower
- Keywords
- Amputation, prosthesis,psychometrics, questionnaires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 20 Nov 2017 (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.
The aim of this study is to investigate the Reliability and construct validity of the Turkish version of the Prosthesis donning and doffing questionnaire in transtibial amputees.
Detailed description
Knowing that a socket and suspension system should be donned and doffed few times during the day and night, it is important to measure ease of donning and doffing. Effortless donning and doffing does appear to have a posi- tive effect on satisfaction with a prosthesis. The socket and suspension systems require different methods of don and doff, some of which are time-consuming and necessi- tate more hand strength and cognitive effort than others. The pin/lock suspension needs few re-adjustments of residual limb within the socket so that the pin is fully locked distally. The seal-in system, for example, needs a longer period as first the amputee needs to spray either the inner socket or the seals, and then remove the socket valve and push the limb into the socket and put back the valve. Instruments are available to evaluate socket comfort such as the socket comfort score, yet to the authors' knowledge no instrument has been developed that focuses on donning and doffing quality of prosthesis. The clearer the insight into suspension systems, the easier will be the selection for prosthetist.
There are different questionnaires in the fields of prosthetics and orthotics such as Prosthetic Evaluation Questionnaire (PEQ), Trinity Amputation and Prosthesis Experience Scales (TAPES), Orthotic Prosthetic User's Survey (OPUS), Houghton scale of prosthetic use, and Amputee Body Image Scale (ABIS) However, few of these instruments address donning and doffing of prosthesis. There is no questionnaire in Turkish available to evaluate the donning and doffing procedures of suspension systems. Thus, the aim of this study is to investigate the Reliability and construct validity of the Turkish version of the Prosthesis donning and doffing questionnaire in transtibial amputees.
After obtaining permission from the developers of the Prosthesis donning and doffing questionnaire, the Turkish version of the instrument will be developed. For the translation process, established guidelines for patient reported outcome (PRO) instrument translation and include both forward and backward (reverse) translation of instructions, items, and response options by independent translators; review by bilingual experts; reconciliation of translations; and cognitive testing of the translated instruments, as described by Eremenco et al., 2005 or Reeve et al., 2013 were followed.The necessity of performing a cultural adaptation for the use of the Turkish version among Turkish amputees will be assessed. Level of education part of the manuscript is planned to be changed bacause it doesn't fit the education system in Turkey). After discussions between the study investigators and translators, a Turkish version of the Prosthesis donning and doffing questionnaire that corresponded as closely as possible to the original survey will be produced. Each subject will be asked to complete the Turkish version of the Prosthesis donning and doffing questionnaire twice (1-3 days apart). To evaluate the validity of the Turkish version of the Prosthesis donning and doffing questionnaire, the Nottingham Health Profile(NHP), Satisfaction with Prosthesis -SATPRO surveys will be used.
Satisfaction with the prosthesis has the following subscales: aesthetic satisfaction with the prosthesis, weight satisfaction with the prosthesis and functional satisfaction with the prosthesis. The weight satisfaction subscale has just one item, which is answered with a 5-point Likert-type scale, whereas both aesthetic satisfaction and functional satisfaction with prosthesis have five items, each answeredwith a 5-point Likert-type scale.
The Turkish version of Nottingham Health Profile(NHP), a generic quality of life measurement tool, has been showed to be a valid and reliable outcome measurement. For this reason it will be used to analyse the construct validity of the Prosthesis donning and doffing questionnaire. NHP (translated by Küçükdeveci et a.) includes the following six subdomains: energy level, physical activities, pain, sleep, emotional reaction and social isolation. The sum of the scores of each subdomain equals.12 The SATPro is a 15-item questionnaire that measures general satisfaction with a prosthesis. The Turkish version of the questionnaire, developed by Simsek, was used. Each item on the questionnaire is scored between 0 and 3.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group: Transtibial amputees | – | Other: Satisfaction with Prosthesis -SATPRO, Other: Nottingham Health Profile-NHP, Other: Prosthesis donning and doffing questionnaireAfter translation/retranslation of the Prosthesis donning and doffing questionnaire, transtibial amputees will be asked to complete a quality of life evaluation Nottingham Health Profile-NHP, a satisfaction evaluation Satisfaction with Prosthesis -SATPRO and the Turkish version of the Prosthesis donning and doffing questionnaire twice (1-3 days apart). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Transtibial amputees aged 18-65 years and using their well fitted prosthesis at least 1 year
Key inclusion criteria (1 listed)
- Transtibial amputee, who used prosthesis for at least 1 year and had no cognitive disorders.
Key exclusion criteria (4 listed)
- Bilateral amputation or upper extremity amputation
- Amputation levels other than transtibial
- Cognitif impairement
- Presence of neuroma, bony growths, skin lesions, wounds leading unability to use prosthesis.
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 |
|---|---|---|
| Satisfaction with Prosthesis -SATPROquestionnaire 1 | Other | Test group: Transtibial amputees |
| Nottingham Health Profile-NHPquestionnaire 2 | Other | Test group: Transtibial amputees |
| Prosthesis donning and doffing questionnairequestionnaire 3 | Other | Test group: Transtibial amputees |
Primary outcome
Prosthesis donning and doffing questionnaire
Time frame: Day 0
Satisfaction was measured through Prosthesis donning and doffing questionnaire. The total score may be categorized into "low, moderate, and high" as follows-total score ⩽ 2: low; total score = 3 and 4: moderate; and total score ⩾ 5: high. The higher score may be interpreted as higher quality and satisfaction with the donning and doffing.
Prosthesis donning and doffing questionnaire
Time frame: Day 3
Satisfaction was measured through Prosthesis donning and doffing questionnaire. The total score may be categorized into "low, moderate, and high" as follows-total score ⩽ 2: low; total score = 3 and 4: moderate; and total score ⩾ 5: high. The higher score may be interpreted as higher quality and satisfaction with the donning and doffing.
4 secondary outcomes
Satisfaction with Prosthesis -SATPRO
Time frame: Day 0
Satisfaction with Prosthesis -SATPRO
Time frame: Day 3
Nottingham Health Profile
Time frame: Day 0
Nottingham Health Profile
Time frame: Day 3
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 2 Jul 2019.
- Background: PubMed 9690489Zhang M, Turner-Smith AR, Tanner A, Roberts VC. Clinical investigation of the pressure and shear stress on the trans-tibial stump with a prosthesis. Med Eng Phys. 1998 Apr;20(3):188-98. doi: 10.1016/s1350-4533(98)00013-7.
- Results publication: PubMed 28190376Abu Osman NA, Eshraghi A, Gholizadeh H, Wan Abas WAB, Lechler K. Prosthesis donning and doffing questionnaire: Development and validation. Prosthet Orthot Int. 2017 Dec;41(6):571-578. doi: 10.1177/0309364617690397. Epub 2017 Feb 13.
- Results publication: PubMed 15804318Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.
- Results publication: PubMed 10826123Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.
- Results publication: PubMed 25085713Kuru P, Akyuz G, Yagci I, Giray E. Hypovitaminosis D in widespread pain: its effect on pain perception, quality of life and nerve conduction studies. Rheumatol Int. 2015 Feb;35(2):315-22. doi: 10.1007/s00296-014-3099-7. Epub 2014 Aug 2.
- Results publication: PubMed 22494367Schaffalitzky E, Gallagher P, Maclachlan M, Wegener ST. Developing consensus on important factors associated with lower limb prosthetic prescription and use. Disabil Rehabil. 2012;34(24):2085-94. doi: 10.3109/09638288.2012.671885. Epub 2012 Apr 12.
- Results publication: PubMed 22269941Eshraghi A, Osman NA, Gholizadeh H, Karimi M, Ali S. Pistoning assessment in lower limb prosthetic sockets. Prosthet Orthot Int. 2012 Mar;36(1):15-24. doi: 10.1177/0309364611431625. Epub 2012 Jan 22.
- Individual participant dataSharing planned: No
Related trials for Amputation; Traumatic, Leg, Lower
Recruiting
Transtibial Osseointegration
Amputation; Traumatic, Leg, Lower
Recruiting
REsistance and LOADing Exercise for Bone Health
Amputation of Lower Limb Below Knee, Amputation, Traumatic
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users
Lower Limb Amputation, Prosthesis Users
Active, not recruitingObservational study
Kinematics of Ewing Amputees
Lower Extremity Amputation, Trans-Tibial Amputation
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.
Giray Esra, MD study director
Marmara University
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 Amputation; Traumatic, Leg, Lower, run by Marmara University 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 1 inclusion and 4 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 2 Jul 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 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?
Prosthesis donning and doffing questionnaire (time frame: Day 0). The study lists 2 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 NCT03347682, which also lists 7 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 2 Jul 2019.