Diabetic Foot UlcerNCT03890172
Efficacy of Platelets Rich Plasma as a Therapeutic Tool in Diabetic Foot Ulcers
An observational study of Diabetic Foot Ulcer, run by Assiut University at 1 site in Egypt.
Trial summary
using platelet-rich plasma (PRP) in healing diabetic foot ulcers (DFUs), and to compare the rate of healing and final outcome with conventional therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- 20-100 ml venous blood will be drawn the from patient into sterilized centrifuge tube ,following centrifuge to separate PRP and at the bed side and tricked onto the ulcer twice weekly and standard treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2019to 30 Dec 2021
- 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 80 years
- All sexes
- Adult, Older adult
Study population: , The study included 60 patients of both sex from 18 to 80 years, with clean chronic diabetic foot ulcers divided into 2 equal groups. The study group in which PRP was used, and the control group receiving standard therapy The formed PRP was applied to the wound twice weekly.
Who may be able to join
- diabetic patients 18 to 80 years of age, with at least one cutaneous ulcer, which did not improve significantly after at least 4 week ulcer standard treatments
- ankle brachial index value ≥ 0.6
- platelet count ≥ 100,000 /mm 3
- no history of various drug or dressing allergies
Who cannot join
- - ulcer is due to non diabetic etiology
- patients blood vessels are non compressible for ankle brachial index (ABI )testing
- the presence of an infected wound and/or osteomyelitis, and/or a completely necrotic ulcer
- active oncological disease. systemic treatment medications like corticosteroids, immunosuppressive agents, as well as radiation or chemotherapy at the target sites within 3 weeks before this study.
- Screening platelets count less than 100,000mm3
- Screening hemoglobin less than10.5mg/dl
- End stages renal disease,haematological,collagen vascular disease and bleeding disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Platelets Rich Plasma as a Therapeutic Tool in Chronic Non Healing Diabetic Foot Ulcers
using platelet-rich plasma (PRP) in healing diabetic foot ulcers (DFUs), and to compare the rate of healing and final outcome with conventional therapy.
Read the detailed description
Diabetic foot ulcers (DFU) are one of the most frequent and difficult complications in diabetes. The risk for a diabetic patient to develop an ulcer during his life is estimated as being 25%. Ulcers are a frequent cause of lower limbs amputation and 84% of lower limb amputations are preceded by ulcers .
Diabetic ulcer (DU) is not only a serious clinical problem with negative impacts on both the life quality and survival time, but also an economic burden with significant contribution to high cost and lengthy hospitalizations. Furthermore, the non healing diabetic cutaneous ulcers along with the subsequent amputations may bring about costly to treat and painful disabilities. However, healing of the DU may be improved and most of the amputations may be prevented by more effective treatments based on diabetic education .
In spite of the high prevalence and morbidity associated with DFUs, current treatment options are limited. Current standard management consists of surgical debridement followed by frequent dressing changes with tight infection and glycemic control. Despite this comprehensive approach, complication and amputation rates remain high.
The use of platelet-rich plasma (PRP) has emerged as an adjunctive method for treating DFUs.
Platelet-rich plasma (PRP) preparations were first described in the 1980s as plasma with a platelet count above that found normally in peripheral blood.
First used in the field of hematology, PRP use has expanded throughout the fields of dermatology, oral-maxillofacial surgery, plastic surgery, cardiac surgery, ophthalmology, urology, and gynecology .
The concentration of platelets in PRP is 2-6 folds higher than that of whole blood .
The curative properties of PRP rely on the fact that platelets are a physiological reservoir of a variety of growth factors, with healing function which have an active role in tissue regeneration .
Platelets contain proteins, known as growth factors that trigger biological effects including directed cell migration (i.e. chemotaxis), angiogenesis, cell proliferation and differentiation, which are key elements in the process of tissue repair and regeneration.
Specifically, the platelet alpha-granules contain several of these molecules, including: platelet derived growth factor (PDGF),transforming growth factor B ( TGF-β), vascular endothelial growth factor (VEGF), epithelial growth factor (EGF), fibrinogen, fibronectin, and vitronectin.
In addition, platelet delta granules contain serotonin, histamine, dopamine, calcium, and adenosine, which act in tandem with the aforementioned growth factors to regulate wound healing .
platelets exert antimicrobial activity against some bacteria of the skin, and clinical data shows that the presence of infection is reduced in PRP-treated wounds.
The advantages and merits of PRP are apparent since it is easy, cost-effective and much more lasting compared to other standard treatments and being autologous in nature, it is free from communicable pathogens, making it a safe treatment modality with good clinical results
- Conditions
- Diabetic Foot Ulcer
- Being tested
- 20-100 ml venous blood will be drawn the from patient into sterilized centrifuge tube ,following centrifuge to separate PRP and at the bed side and tricked onto the ulcer twice weekly, standard treatment
- Keywords
- platelets rich plasma
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-100 ml venous blood will be drawn the from patient into sterilized centrifuge tube ,following centrifuge to separate PRP and at the bed side and tricked onto the ulcer twice weeklyOther
topical application of platelets rich plasma after Centrifugation at diabetic foot ulcer to study group ,history taking . Ankle brachial index (ABI) measuring and laboratory testes including hemoglobin A1c ( HgA1)c,cbc and prothrombin time( pt) and prothrombin concentration ( pc)
standard treatmentOther
Subjects in the control group will receive Standard Wound Care treatment for chronic ulcers according to accepted medical practices.
| Study group | Role | What they receive |
|---|---|---|
| study group | in this group the investigators will be managing diabetic wounds with platelet rich plasma treatment. Receives: Other: 20-100 ml venous blood will be drawn the from patient into sterilized centrifuge tube ,following centrifuge to separate PRP and at the bed side and tricked onto the ulcer twice weekly | |
| control group | In this group patients will receive the standard treatment in form of debridement and dressing twice weekly Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of ulcer size
ulcer size will be measured with ruler/probe for length, width and depth and estimated by calculating the ulcer size in centimeter (cm 2).
Measured: 16 weeks
Secondary outcomes (1)
time of wound healing
Complete wound closure over period of 16 weeks
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start30 Jul 2019 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Mohammed Riad, Assiut University
- Investigators
- Hanan Mohamoud, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890172
- Sponsor's protocol ID
- Platelets rich plasma
- Status last verified
- Mar 2019
- First submitted
- 15 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bernuzzi G, Tardito S, Bussolati O, Adorni D, Cantarelli S, Fagnoni F, Rossetti A, Azzarone M, Ficarelli E, Caleffi E, Gazzola G, Franchini M. Platelet gel in the treatment of cutaneous ulcers: the experience of the Immunohaematology and Transfusion Centre of Parma. Blood Transfus. 2010 Oct;8(4):237-47. doi: 10.2450/2009.0118-09.
PubMed 20967164Piccin A, Di Pierro AM, Canzian L, Primerano M, Corvetta D, Negri G, Mazzoleni G, Gastl G, Steurer M, Gentilini I, Eisendle K, Fontanella F. Platelet gel: a new therapeutic tool with great potential. Blood Transfus. 2017 Jul;15(4):333-340. doi: 10.2450/2016.0038-16. Epub 2016 Jul 25.
PubMed 27483482Apelqvist J, Bakker K, van Houtum WH, Schaper NC; International Working Group on the Diabetic Foot (IWGDF) Editorial Board. The development of global consensus guidelines on the management of the diabetic foot. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S116-8. doi: 10.1002/dmrr.832.
PubMed 18442162Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018 Jan;1411(1):153-165. doi: 10.1111/nyas.13569.
PubMed 29377202Mohammadi MH, Molavi B, Mohammadi S, Nikbakht M, Mohammadi AM, Mostafaei S, Norooznezhad AH, Ghorbani Abdegah A, Ghavamzadeh A. Evaluation of wound healing in diabetic foot ulcer using platelet-rich plasma gel: A single-arm clinical trial. Transfus Apher Sci. 2017 Apr;56(2):160-164. doi: 10.1016/j.transci.2016.10.020. Epub 2016 Nov 2.
PubMed 27839965Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.
PubMed 29457008Andia E R-AJ, Martin I, Abate M. Current concepts and translational uses of platelet rich plasma biotechnology. Biotechnology 2015. https://doi.org/10.5772/59954 Google Scholar
San Sebastian KM, Lobato I, Hernandez I, Burgos-Alonso N, Gomez-Fernandez MC, Lopez JL, Rodriguez B, March AG, Grandes G, Andia I. Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study. BMC Fam Pract. 2014 Dec 30;15:211. doi: 10.1186/s12875-014-0211-8.
PubMed 25547983Andia I, Abate M. Platelet-rich plasma: underlying biology and clinical correlates. Regen Med. 2013 Sep;8(5):645-58. doi: 10.2217/rme.13.59.
PubMed 23998756Anitua E, Aguirre JJ, Algorta J, Ayerdi E, Cabezas AI, Orive G, Andia I. Effectiveness of autologous preparation rich in growth factors for the treatment of chronic cutaneous ulcers. J Biomed Mater Res B Appl Biomater. 2008 Feb;84(2):415-21. doi: 10.1002/jbm.b.30886.
PubMed 17595032Kakudo N, Kushida S, Ogura N, Hara T, Suzuki K. The use of autologous platelet rich plasma in the treatment of intractable skin ulcer. Open J Reg Med. 2012;1:29-32. N, Kushida S, Ogura N, Hara T, Suzuki K. The use of autologous platelet rich plasma in the treatment of intractable skin ulcer. Open J Reg Med. 2012;1:29-32.
Liao HT, Marra KG, Rubin JP. Application of platelet-rich plasma and platelet-rich fibrin in fat grafting: basic science and literature review. Tissue Eng Part B Rev. 2014 Aug;20(4):267-76. doi: 10.1089/ten.TEB.2013.0317. Epub 2013 Dec 18.
PubMed 24004354Carter MJ, Fylling CP, Parnell LK. Use of platelet rich plasma gel on wound healing: a systematic review and meta-analysis. Eplasty. 2011;11:e38. Epub 2011 Sep 15.
PubMed 22028946Lacci KM, Dardik A. Platelet-rich plasma: support for its use in wound healing. Yale J Biol Med. 2010 Mar;83(1):1-9.
PubMed 20351977
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelets Rich Plasma as a Therapeutic Tool in Chronic Non Healing Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03890172
- Acronym / sponsor ID
- Platelets rich plasma
- Conditions
- Diabetic Foot Ulcer
- Keywords
- platelets rich plasma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jul 2019 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 26 Mar 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.
using platelet-rich plasma (PRP) in healing diabetic foot ulcers (DFUs), and to compare the rate of healing and final outcome with conventional therapy.
Detailed description
Diabetic foot ulcers (DFU) are one of the most frequent and difficult complications in diabetes. The risk for a diabetic patient to develop an ulcer during his life is estimated as being 25%. Ulcers are a frequent cause of lower limbs amputation and 84% of lower limb amputations are preceded by ulcers .
Diabetic ulcer (DU) is not only a serious clinical problem with negative impacts on both the life quality and survival time, but also an economic burden with significant contribution to high cost and lengthy hospitalizations. Furthermore, the non healing diabetic cutaneous ulcers along with the subsequent amputations may bring about costly to treat and painful disabilities. However, healing of the DU may be improved and most of the amputations may be prevented by more effective treatments based on diabetic education .
In spite of the high prevalence and morbidity associated with DFUs, current treatment options are limited. Current standard management consists of surgical debridement followed by frequent dressing changes with tight infection and glycemic control. Despite this comprehensive approach, complication and amputation rates remain high.
The use of platelet-rich plasma (PRP) has emerged as an adjunctive method for treating DFUs.
Platelet-rich plasma (PRP) preparations were first described in the 1980s as plasma with a platelet count above that found normally in peripheral blood.
First used in the field of hematology, PRP use has expanded throughout the fields of dermatology, oral-maxillofacial surgery, plastic surgery, cardiac surgery, ophthalmology, urology, and gynecology .
The concentration of platelets in PRP is 2-6 folds higher than that of whole blood .
The curative properties of PRP rely on the fact that platelets are a physiological reservoir of a variety of growth factors, with healing function which have an active role in tissue regeneration .
Platelets contain proteins, known as growth factors that trigger biological effects including directed cell migration (i.e. chemotaxis), angiogenesis, cell proliferation and differentiation, which are key elements in the process of tissue repair and regeneration.
Specifically, the platelet alpha-granules contain several of these molecules, including: platelet derived growth factor (PDGF),transforming growth factor B ( TGF-β), vascular endothelial growth factor (VEGF), epithelial growth factor (EGF), fibrinogen, fibronectin, and vitronectin.
In addition, platelet delta granules contain serotonin, histamine, dopamine, calcium, and adenosine, which act in tandem with the aforementioned growth factors to regulate wound healing .
platelets exert antimicrobial activity against some bacteria of the skin, and clinical data shows that the presence of infection is reduced in PRP-treated wounds.
The advantages and merits of PRP are apparent since it is easy, cost-effective and much more lasting compared to other standard treatments and being autologous in nature, it is free from communicable pathogens, making it a safe treatment modality with good clinical results
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: 20-100 ml venous blood will be drawn the from patient into sterilized centrifuge tube ,following centrifuge to separate PRP and at the bed side and tricked onto the ulcer twice weeklyin this group the investigators will be managing diabetic wounds with platelet rich plasma treatment. |
| control group | – | Other: standard treatmentIn this group patients will receive the standard treatment in form of debridement and dressing twice weekly |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- , The study included 60 patients of both sex from 18 to 80 years, with clean chronic diabetic foot ulcers divided into 2 equal groups. The study group in which PRP was used, and the control group receiving standard therapy The formed PRP was applied to the wound twice weekly.
Key inclusion criteria (4 listed)
- diabetic patients 18 to 80 years of age, with at least one cutaneous ulcer, which did not improve significantly after at least 4 week ulcer standard treatments
- ankle brachial index value ≥ 0.6
- platelet count ≥ 100,000 /mm 3
- no history of various drug or dressing allergies
Key exclusion criteria (7 listed)
- - ulcer is due to non diabetic etiology
- patients blood vessels are non compressible for ankle brachial index (ABI )testing
- the presence of an infected wound and/or osteomyelitis, and/or a completely necrotic ulcer
- active oncological disease. systemic treatment medications like corticosteroids, immunosuppressive agents, as well as radiation or chemotherapy at the target sites within 3 weeks before this study.
- Screening platelets count less than 100,000mm3
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 |
|---|---|---|
| 20-100 ml venous blood will be drawn the from patient into sterilized centrifuge tube ,following centrifuge to separate PRP and at the bed side and tricked onto the ulcer twice weeklytopical application of platelets rich plasma after Centrifugation at diabetic foot ulcer to study group ,history taking . Ankle brachial index (ABI) measuring and laboratory testes including hemoglobin A1c ( HgA1)c,cbc and prothrombin time( pt) and prothrombin concentration ( pc) | Other | study group |
| standard treatmentSubjects in the control group will receive Standard Wound Care treatment for chronic ulcers according to accepted medical practices. | Other | control group |
Primary outcome
Change of ulcer size
Time frame: 16 weeks
ulcer size will be measured with ruler/probe for length, width and depth and estimated by calculating the ulcer size in centimeter (cm 2).
1 secondary outcome
time of wound healing
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Background: PubMed 20967164Bernuzzi G, Tardito S, Bussolati O, Adorni D, Cantarelli S, Fagnoni F, Rossetti A, Azzarone M, Ficarelli E, Caleffi E, Gazzola G, Franchini M. Platelet gel in the treatment of cutaneous ulcers: the experience of the Immunohaematology and Transfusion Centre of Parma. Blood Transfus. 2010 Oct;8(4):237-47. doi: 10.2450/2009.0118-09.
- Background: PubMed 27483482Piccin A, Di Pierro AM, Canzian L, Primerano M, Corvetta D, Negri G, Mazzoleni G, Gastl G, Steurer M, Gentilini I, Eisendle K, Fontanella F. Platelet gel: a new therapeutic tool with great potential. Blood Transfus. 2017 Jul;15(4):333-340. doi: 10.2450/2016.0038-16. Epub 2016 Jul 25.
- Background: PubMed 18442162Apelqvist J, Bakker K, van Houtum WH, Schaper NC; International Working Group on the Diabetic Foot (IWGDF) Editorial Board. The development of global consensus guidelines on the management of the diabetic foot. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S116-8. doi: 10.1002/dmrr.832.
- Background: PubMed 29377202Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018 Jan;1411(1):153-165. doi: 10.1111/nyas.13569.
- Background: PubMed 27839965Mohammadi MH, Molavi B, Mohammadi S, Nikbakht M, Mohammadi AM, Mostafaei S, Norooznezhad AH, Ghorbani Abdegah A, Ghavamzadeh A. Evaluation of wound healing in diabetic foot ulcer using platelet-rich plasma gel: A single-arm clinical trial. Transfus Apher Sci. 2017 Apr;56(2):160-164. doi: 10.1016/j.transci.2016.10.020. Epub 2016 Nov 2.
- Background: PubMed 29457008Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.
- BackgroundAndia E R-AJ, Martin I, Abate M. Current concepts and translational uses of platelet rich plasma biotechnology. Biotechnology 2015. https://doi.org/10.5772/59954 Google Scholar
- Background: PubMed 25547983San Sebastian KM, Lobato I, Hernandez I, Burgos-Alonso N, Gomez-Fernandez MC, Lopez JL, Rodriguez B, March AG, Grandes G, Andia I. Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study. BMC Fam Pract. 2014 Dec 30;15:211. doi: 10.1186/s12875-014-0211-8.
- Background: PubMed 23998756Andia I, Abate M. Platelet-rich plasma: underlying biology and clinical correlates. Regen Med. 2013 Sep;8(5):645-58. doi: 10.2217/rme.13.59.
- Background: PubMed 17595032Anitua E, Aguirre JJ, Algorta J, Ayerdi E, Cabezas AI, Orive G, Andia I. Effectiveness of autologous preparation rich in growth factors for the treatment of chronic cutaneous ulcers. J Biomed Mater Res B Appl Biomater. 2008 Feb;84(2):415-21. doi: 10.1002/jbm.b.30886.
- BackgroundKakudo N, Kushida S, Ogura N, Hara T, Suzuki K. The use of autologous platelet rich plasma in the treatment of intractable skin ulcer. Open J Reg Med. 2012;1:29-32. N, Kushida S, Ogura N, Hara T, Suzuki K. The use of autologous platelet rich plasma in the treatment of intractable skin ulcer. Open J Reg Med. 2012;1:29-32.
- Background: PubMed 24004354Liao HT, Marra KG, Rubin JP. Application of platelet-rich plasma and platelet-rich fibrin in fat grafting: basic science and literature review. Tissue Eng Part B Rev. 2014 Aug;20(4):267-76. doi: 10.1089/ten.TEB.2013.0317. Epub 2013 Dec 18.
- Individual participant dataSharing planned: Undecided
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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.
Hanan Mohamoud study director
Assiut 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 Diabetic Foot Ulcer, run by Assiut University at 1 site in Egypt.
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 7 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: status not confirmed, as of the sponsor's last update on 26 Mar 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanaa Mohammed (01094608083, hanaaried@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of ulcer size (time frame: 16 weeks). 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 NCT03890172, which also lists 14 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 26 Mar 2019.