Behçet's DiseaseNCT06296004
Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease
An observational study of Behçet's Disease, run by Assiut University.
Trial summary
Relation between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Behçet's Disease
- What is being tested?
- Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Apr 2025
- How long will I take part?
- 2 Years
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will include 80 participants: Group 1: 40 patients with who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease (Disease et al., 2014). . Group 2: 40 healthy matched controls.
Who may be able to join
- Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease .
- Accept to participate in the current study -
Who cannot join
- Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease).
- Patients with high myopia or media opacities preventing high-quality imaging like cataract and cornea guttata, vitreoretinal disease, previous retinal surgery, macular edema, glaucoma or neurological disease.
- Patients with other comorbidities as diabetes, hypertension were excluded from the study.
- Refused to participate in the current study.
- -
Trial locations and contacts
No sites are listed yet.
Eman Hamed, professor doctor contact
About this study
Official title: Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease
Relation between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease
Read the detailed description
Behçet disease (BD) is a multisystemic, autoinflammatory, chronic illness that is quite common in the nations along the ancient Silk Road. It is characterized by immune-mediated vasculitis, which can affect blood vessels of any size throughout all organ systems Vascular involvement, is one of the more serious symptoms of BD, which is considered to have a poor prognostic value. The majority of research on vascular involvement in BD focuses on large vessel involvement; however, less research discusses microvascular damage. Capillaroscopy is a non-invasive diagnostic method used to assess small vessels in the microcirculation Furthermore, ocular inflammation is the most prevalent form affecting more than 70% of Behçet diseased patients in the form of relapsing, remitting uveitis Fluorescein angiography is currently the gold standard for documenting and tracking posterior segment involvement in BD because it can easily detects retinal ischemia, macular edema, and retinal vascular leakage . Nevertheless, this process is invasive, necessitating the injection of an external dye, and its depth resolution is restricted Recently, optical coherence tomography angiography (OCT-A) has emerged as a highly effective method for obtaining high resolution en face images of the choroidal and retinal microvasculature, as well as for analyzing changes in the choriocapillaris, deep capillary plexus, and superficial capillary plexus independently . OCT-A allows for the assessment of both qualitative and quantitative alterations within the retinal microvasculature. Few research have looked into the use of OCT-A in Behçet uveitis, despite the fact that its role in the evaluation of retinal vascular diseases, such as diabetic retinopathy, retinal venous occlusions, retinal arterial occlusions, and age-related macular degeneration, has been thoroughly examined in the recent literature It has recently been proposed that venous wall thickness (VWT), measured by Doppler ultrasonography (US), can serve as an indirect sonographic marker for the extent of vascular end organ damage, including venous illness. Increased VWT, particularly in the femoral and popliteal veins, has been shown in numerous investigations to be a highly significant clinical characteristic in BD However, whether US findings are correlated with vascular involvement in BD is still unknown. It has been determined that the most suitable site to evaluate VWT using US is the common femoral vein (CFV). A sensitivity of 81-22% and a specificity of 78.4-81.1.1% have been reported for the VWT cut-off point of ≥0.5 mm in the diagnosis of BD. It has therefore been suggested as an efficient and non-invasive method for diagnosing BD
- Conditions
- Behçet's Disease
- Being tested
- Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.SDevice
Complete blood count (CBC) Erythrocyte sedimentation rate (ESR) measured by standard westergren method (mm/h).
Serum C-reactive protein (CRP) Liver function tests: aspartate transaminase (AST), alanine transaminase (ALT), serum albumin, serum bilirubin.
Renal function tests: serum creatinine and blood urea. Complete urine analysis.
Optical coherence tomography angiography (OCTA): . Bilateral common femoral vein (CFV) Doppler US
| Study group | Role | What they receive |
|---|---|---|
| adult patient with Behçet's Disease | . Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease . Receives: Device: Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S | |
| healthy subjects | apparently healthy subjects Receives: Device: Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring parameter of Nail Fold Capillaroscopy in behcet disease
using previous parameters in diagnosis of vascular affection in behcet disease
Measured: 1 year
measuring parameter of Optical Coherence Tomography Angiography in behcet disease
using previous parameters in diagnosis of vascular affection in behcet disease
Measured: 1 year
measuring parameter of Femoral Vein Wall Thickness in behcet disease
using previous parameters in diagnosis of vascular affection in behcet disease
Measured: 1year
Secondary outcomes (3)
relation between Nail Fold Capillaroscopy and activity of behcet disease
using previous parameters in measuring disease activity
Measured: 1 years
relation between Optical Coherence Tomography Angiography and activity of behcet disease
using previous parameters in measuring disease activity
Measured: 1 year
relation between Femoral Vein Wall Thickness and activity of behcet disease
using previous parameters in measuring disease activity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Behçet's DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzahraa Awny Fathy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296004
- Sponsor's protocol ID
- CAPILLAROSCOPY behcet disease
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alibaz-Oner F, Ergelen R, Yildiz Y, Aldag M, Yazici A, Cefle A, Koc E, Artim Esen B, Mumcu G, Ergun T, Direskeneli H. Femoral vein wall thickness measurement: A new diagnostic tool for Behcet's disease. Rheumatology (Oxford). 2021 Jan 5;60(1):288-296. doi: 10.1093/rheumatology/keaa264.
PubMed 32756998Alibaz-Oner F, Direskeneli H. Assessment of venous wall thickness with Doppler ultrasonography may be a diagnostic tool for Behcet's disease. Int J Rheum Dis. 2019 May;22(5):767-768. doi: 10.1111/1756-185X.13574. No abstract available.
PubMed 31062939Alten F, Heiduschka P, Clemens CR, Eter N. Exploring choriocapillaris under reticular pseudodrusen using OCT-Angiography. Graefes Arch Clin Exp Ophthalmol. 2016 Nov;254(11):2165-2173. doi: 10.1007/s00417-016-3375-1. Epub 2016 May 18.
PubMed 27193430Bhakta BB, Brennan P, James TE, Chamberlain MA, Noble BA, Silman AJ. Behcet's disease: evaluation of a new instrument to measure clinical activity. Rheumatology (Oxford). 1999 Aug;38(8):728-33. doi: 10.1093/rheumatology/38.8.728.
PubMed 10501420Bonini Filho MA, Adhi M, de Carlo TE, Ferrara D, Baumal CR, Witkin AJ, Reichel E, Kuehlewein L, Sadda SR, Sarraf D, Duker JS, Waheed NK. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN RETINAL ARTERY OCCLUSION. Retina. 2015 Nov;35(11):2339-46. doi: 10.1097/IAE.0000000000000850.
PubMed 26457398Cheng D, Shen M, Zhuang X, Lin D, Dai M, Chen S, Lu F, Wang Y. Inner Retinal Microvasculature Damage Correlates With Outer Retinal Disruption During Remission in Behcet's Posterior Uveitis by Optical Coherence Tomography Angiography. Invest Ophthalmol Vis Sci. 2018 Mar 1;59(3):1295-1304. doi: 10.1167/iovs.17-23113.
PubMed 29625452Chojnowski MM, Felis-Giemza A, Olesinska M. Capillaroscopy - a role in modern rheumatology. Reumatologia. 2016;54(2):67-72. doi: 10.5114/reum.2016.60215. Epub 2016 Jun 3.
PubMed 27407282de Carlo TE, Romano A, Waheed NK, Duker JS. A review of optical coherence tomography angiography (OCTA). Int J Retina Vitreous. 2015 Apr 15;1:5. doi: 10.1186/s40942-015-0005-8. eCollection 2015.
PubMed 27847598International Team for the Revision of the International Criteria for Behcet's Disease (ITR-ICBD). The International Criteria for Behcet's Disease (ICBD): a collaborative study of 27 countries on the sensitivity and specificity of the new criteria. J Eur Acad Dermatol Venereol. 2014 Mar;28(3):338-47. doi: 10.1111/jdv.12107. Epub 2013 Feb 26.
PubMed 23441863Khairallah M, Abroug N, Khochtali S, Mahmoud A, Jelliti B, Coscas G, Lupidi M, Kahloun R, Ben Yahia S. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN PATIENTS WITH BEHCET UVEITIS. Retina. 2017 Sep;37(9):1678-1691. doi: 10.1097/IAE.0000000000001418.
PubMed 28002270Lupidi M, Cerquaglia A, Chhablani J, Fiore T, Singh SR, Cardillo Piccolino F, Corbucci R, Coscas F, Coscas G, Cagini C. Optical coherence tomography angiography in age-related macular degeneration: The game changer. Eur J Ophthalmol. 2018 Jul;28(4):349-357. doi: 10.1177/1120672118766807. Epub 2018 Apr 6.
PubMed 29623720• Onan, D., Uysal, P., Hayran, Y., Şahin Dalgıç, G., Hayran, M., Artüz, F. & Yalçin, B. (2019) Dermatoscopic Assessment of Nailfold Capillary Abnormalities in Behçet's Disease and Correlation of the Findings with Disease Activity and Severity. Dermatologica Sinica, 37, 40-45.
Samara WA, Shahlaee A, Adam MK, Khan MA, Chiang A, Maguire JI, Hsu J, Ho AC. Quantification of Diabetic Macular Ischemia Using Optical Coherence Tomography Angiography and Its Relationship with Visual Acuity. Ophthalmology. 2017 Feb;124(2):235-244. doi: 10.1016/j.ophtha.2016.10.008. Epub 2016 Nov 23.
PubMed 27887743Samara WA, Shahlaee A, Sridhar J, Khan MA, Ho AC, Hsu J. Quantitative Optical Coherence Tomography Angiography Features and Visual Function in Eyes With Branch Retinal Vein Occlusion. Am J Ophthalmol. 2016 Jun;166:76-83. doi: 10.1016/j.ajo.2016.03.033. Epub 2016 Mar 31.
PubMed 27038893Sambhav K, Grover S, Chalam KV. The application of optical coherence tomography angiography in retinal diseases. Surv Ophthalmol. 2017 Nov-Dec;62(6):838-866. doi: 10.1016/j.survophthal.2017.05.006. Epub 2017 Jun 1.
PubMed 28579550
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease
- ClinicalTrials.gov ID
- NCT06296004
- Acronym / sponsor ID
- CAPILLAROSCOPY behcet disease
- Conditions
- Behçet's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 6 Mar 2024 (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.
Relation between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease
Detailed description
Behçet disease (BD) is a multisystemic, autoinflammatory, chronic illness that is quite common in the nations along the ancient Silk Road. It is characterized by immune-mediated vasculitis, which can affect blood vessels of any size throughout all organ systems Vascular involvement, is one of the more serious symptoms of BD, which is considered to have a poor prognostic value. The majority of research on vascular involvement in BD focuses on large vessel involvement; however, less research discusses microvascular damage. Capillaroscopy is a non-invasive diagnostic method used to assess small vessels in the microcirculation Furthermore, ocular inflammation is the most prevalent form affecting more than 70% of Behçet diseased patients in the form of relapsing, remitting uveitis Fluorescein angiography is currently the gold standard for documenting and tracking posterior segment involvement in BD because it can easily detects retinal ischemia, macular edema, and retinal vascular leakage . Nevertheless, this process is invasive, necessitating the injection of an external dye, and its depth resolution is restricted Recently, optical coherence tomography angiography (OCT-A) has emerged as a highly effective method for obtaining high resolution en face images of the choroidal and retinal microvasculature, as well as for analyzing changes in the choriocapillaris, deep capillary plexus, and superficial capillary plexus independently . OCT-A allows for the assessment of both qualitative and quantitative alterations within the retinal microvasculature. Few research have looked into the use of OCT-A in Behçet uveitis, despite the fact that its role in the evaluation of retinal vascular diseases, such as diabetic retinopathy, retinal venous occlusions, retinal arterial occlusions, and age-related macular degeneration, has been thoroughly examined in the recent literature It has recently been proposed that venous wall thickness (VWT), measured by Doppler ultrasonography (US), can serve as an indirect sonographic marker for the extent of vascular end organ damage, including venous illness. Increased VWT, particularly in the femoral and popliteal veins, has been shown in numerous investigations to be a highly significant clinical characteristic in BD However, whether US findings are correlated with vascular involvement in BD is still unknown. It has been determined that the most suitable site to evaluate VWT using US is the common femoral vein (CFV). A sensitivity of 81-22% and a specificity of 78.4-81.1.1% have been reported for the VWT cut-off point of ≥0.5 mm in the diagnosis of BD. It has therefore been suggested as an efficient and non-invasive method for diagnosing BD
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adult patient with Behçet's Disease | – | Device: Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S. Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease . |
| healthy subjects | – | Device: Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.Sapparently healthy subjects |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include 80 participants: Group 1: 40 patients with who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease (Disease et al., 2014). . Group 2: 40 healthy matched controls.
Key inclusion criteria (2 listed)
- Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease .
- Accept to participate in the current study -
Key exclusion criteria (5 listed)
- Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease).
- Patients with high myopia or media opacities preventing high-quality imaging like cataract and cornea guttata, vitreoretinal disease, previous retinal surgery, macular edema, glaucoma or neurological disease.
- Patients with other comorbidities as diabetes, hypertension were excluded from the study.
- Refused to participate in the current study.
- -
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 |
|---|---|---|
| Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.SComplete blood count (CBC) Erythrocyte sedimentation rate (ESR) measured by standard westergren method (mm/h). Serum C-reactive protein (CRP) Liver function tests: aspartate transaminase (AST), alanine transaminase (ALT), serum albumin, serum bilirubin. Renal function tests: serum creatinine and blood urea. Complete urine analysis. Optical coherence tomography angiography (OCTA): . Bilateral common femoral vein (CFV) Doppler US | Device | adult patient with Behçet's Disease, healthy subjects |
Primary outcome
measuring parameter of Nail Fold Capillaroscopy in behcet disease
Time frame: 1 year
using previous parameters in diagnosis of vascular affection in behcet disease
measuring parameter of Optical Coherence Tomography Angiography in behcet disease
Time frame: 1 year
using previous parameters in diagnosis of vascular affection in behcet disease
measuring parameter of Femoral Vein Wall Thickness in behcet disease
Time frame: 1year
using previous parameters in diagnosis of vascular affection in behcet disease
3 secondary outcomes
relation between Nail Fold Capillaroscopy and activity of behcet disease
Time frame: 1 years
relation between Optical Coherence Tomography Angiography and activity of behcet disease
Time frame: 1 year
relation between Femoral Vein Wall Thickness and activity of behcet disease
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 32756998Alibaz-Oner F, Ergelen R, Yildiz Y, Aldag M, Yazici A, Cefle A, Koc E, Artim Esen B, Mumcu G, Ergun T, Direskeneli H. Femoral vein wall thickness measurement: A new diagnostic tool for Behcet's disease. Rheumatology (Oxford). 2021 Jan 5;60(1):288-296. doi: 10.1093/rheumatology/keaa264.
- Background: PubMed 31062939Alibaz-Oner F, Direskeneli H. Assessment of venous wall thickness with Doppler ultrasonography may be a diagnostic tool for Behcet's disease. Int J Rheum Dis. 2019 May;22(5):767-768. doi: 10.1111/1756-185X.13574. No abstract available.
- Background: PubMed 27193430Alten F, Heiduschka P, Clemens CR, Eter N. Exploring choriocapillaris under reticular pseudodrusen using OCT-Angiography. Graefes Arch Clin Exp Ophthalmol. 2016 Nov;254(11):2165-2173. doi: 10.1007/s00417-016-3375-1. Epub 2016 May 18.
- Background: PubMed 10501420Bhakta BB, Brennan P, James TE, Chamberlain MA, Noble BA, Silman AJ. Behcet's disease: evaluation of a new instrument to measure clinical activity. Rheumatology (Oxford). 1999 Aug;38(8):728-33. doi: 10.1093/rheumatology/38.8.728.
- Background: PubMed 26457398Bonini Filho MA, Adhi M, de Carlo TE, Ferrara D, Baumal CR, Witkin AJ, Reichel E, Kuehlewein L, Sadda SR, Sarraf D, Duker JS, Waheed NK. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN RETINAL ARTERY OCCLUSION. Retina. 2015 Nov;35(11):2339-46. doi: 10.1097/IAE.0000000000000850.
- Background: PubMed 29625452Cheng D, Shen M, Zhuang X, Lin D, Dai M, Chen S, Lu F, Wang Y. Inner Retinal Microvasculature Damage Correlates With Outer Retinal Disruption During Remission in Behcet's Posterior Uveitis by Optical Coherence Tomography Angiography. Invest Ophthalmol Vis Sci. 2018 Mar 1;59(3):1295-1304. doi: 10.1167/iovs.17-23113.
- Background: PubMed 27407282Chojnowski MM, Felis-Giemza A, Olesinska M. Capillaroscopy - a role in modern rheumatology. Reumatologia. 2016;54(2):67-72. doi: 10.5114/reum.2016.60215. Epub 2016 Jun 3.
- Background: PubMed 27847598de Carlo TE, Romano A, Waheed NK, Duker JS. A review of optical coherence tomography angiography (OCTA). Int J Retina Vitreous. 2015 Apr 15;1:5. doi: 10.1186/s40942-015-0005-8. eCollection 2015.
- Background: PubMed 23441863International Team for the Revision of the International Criteria for Behcet's Disease (ITR-ICBD). The International Criteria for Behcet's Disease (ICBD): a collaborative study of 27 countries on the sensitivity and specificity of the new criteria. J Eur Acad Dermatol Venereol. 2014 Mar;28(3):338-47. doi: 10.1111/jdv.12107. Epub 2013 Feb 26.
- Background: PubMed 28002270Khairallah M, Abroug N, Khochtali S, Mahmoud A, Jelliti B, Coscas G, Lupidi M, Kahloun R, Ben Yahia S. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN PATIENTS WITH BEHCET UVEITIS. Retina. 2017 Sep;37(9):1678-1691. doi: 10.1097/IAE.0000000000001418.
- Background: PubMed 29623720Lupidi M, Cerquaglia A, Chhablani J, Fiore T, Singh SR, Cardillo Piccolino F, Corbucci R, Coscas F, Coscas G, Cagini C. Optical coherence tomography angiography in age-related macular degeneration: The game changer. Eur J Ophthalmol. 2018 Jul;28(4):349-357. doi: 10.1177/1120672118766807. Epub 2018 Apr 6.
- Background• Onan, D., Uysal, P., Hayran, Y., Şahin Dalgıç, G., Hayran, M., Artüz, F. & Yalçin, B. (2019) Dermatoscopic Assessment of Nailfold Capillary Abnormalities in Behçet's Disease and Correlation of the Findings with Disease Activity and Severity. Dermatologica Sinica, 37, 40-45.
- Individual participant dataSharing planned: No
Related trials for Behçet's Disease
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Not yet recruitingPhase 2
Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
Behçet's Syndrome, Behçet's Syndrome (BS)
RecruitingPhase 2
Baricitinib in the Treatment of Intestinal Behçet's Syndrome
Behcet Syndrome, Intestinal Type
RecruitingPhase 3
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
Behçet Disease
RecruitingPhase 1
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
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.
Eman Hamed, professor doctor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Behçet's Disease, run by Assiut University.
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 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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. 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 Eman Hamed, professor doctor (01066643425), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring parameter of Nail Fold Capillaroscopy in behcet disease (time frame: 1 year). The study lists 3 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 NCT06296004, which also lists 19 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 6 Mar 2024.