Testing Nail capillaroscopy for undifferentiated connective tissue diseases
Official title: Impact of Capillaroscopy on the Management of Undifferentiated Connective Tissue Disease
Impact of Capillaroscopy on the Management of Undifferentiated Connective Tissue Disease: a Randomized Pilot Clinical Study
- 2 groups
- One site, in Québec
- Recruiting
Interventions
- Other intervention
Nail capillaroscopy
The intervention studied as part of the project is capillaroscopy. This examination consists of visualizing the capillaries located at the base of the nail using a device called a capillaroscope. This device magnifies the image of the capillaries to clearly visualize them. Capillaries are the smallest blood vessels, which allow the passage of only one red blood cell at a time. At the nail bed, they form a network of loops and are aligned next to each other. This alignment allows them to be viewed over their entire length. Researchers have described abnormalities in capillaries that are associated with certain diseases involving microvascular damage. The results of capillaroscopy will be reported qualitatively, for all eight long fingers examined.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
CHU de Quebec-Université Laval
Québec, Quebec
Eligibility Criteria
See who this study is looking for8 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Be aged 18 and over;
- +Have been diagnosed with undifferentiated connective tissue disease by a rheumatologist;
- +Meet the preliminary classification criteria for undifferentiated connective tissue disease: present signs and symptoms suggestive of connective tissue disease, but do not meet the criteria for a connective tissue disease and have a positive antinuclear antibody on at least 2 occasions;
- +Have developed the first signs and symptoms of the disease less than 10 years before recruitment.
Exclusion
- −In the opinion of the clinician, have a health condition that does not allow a delay of six months before carrying out the capillaroscopy;
- −Have been diagnosed and/or meet the classification criteria for another connective tissue disease (for example, systemic lupus, etc.);
- −Have already performed a capillaroscopy in the past, regardless of the time or the reason;
- −Be unable to consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → or respond to questionnaires.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to identify or measure a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Nail capillaroscopy.
Registry label: A: Capillaroscopy
Group B receives Nail capillaroscopy.
Registry label: B: Control
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 40 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: 6 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Proportion of participants who transitioned from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease — measured over 6 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06399822 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Nail capillaroscopyDiagnostic test
The intervention studied as part of the project is capillaroscopy. This examination consists of visualizing the capillaries located at the base of the nail using a device called a capillaroscope. This device magnifies the image of the capillaries to clearly visualize them. Capillaries are the smallest blood vessels, which allow the passage of only one red blood cell at a time. At the nail bed, they form a network of loops and are aligned next to each other. This alignment allows them to be viewed over their entire length. Researchers have described abnormalities in capillaries that are associated with certain diseases involving microvascular damage. The results of capillaroscopy will be reported qualitatively, for all eight long fingers examined.
From the trial registry — its own words, unedited.
What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 6 months.
The study as a whole is currently expected to finish around 2027-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 40 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Québec, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Connective tissue diseases (CTD) are a group of diseases with diverse manifestations, most often multisystemic, which share an autoimmune etiology. They include Systemic lupus erythematosus (SLE), Systemic sclerosis (SSc), Sjögren's syndrome (SS), Inflammatory myopathies (IM) and Mixed connective tissue disease (MCTD). Many patients in rheumatology present signs and symptoms of CTD, but without meeting all the classification criteria for one of these diseases. These patients will generally receive a diagnosis of undifferentiated connective tissue disease (UCTD). It is increasingly suggested that there are two subgroups of patients with UCTD: one which will eventually evolve into a better characterized CTD (approximately 30% of patients at 5 years) and another with a more benign prognosis. The optimal management of patients with UCTD is not clearly established. Capillaroscopy is a diagnostic test used in the investigation of patients with CTD. It is a low-cost, non-invasive, rapid and specific test in the evaluation of this class of diseases. Its role is now well established in the diagnosis of SSc and in the investigation of Raynaud's phenomenon. In addition, capillaroscopy helps to identify patients suffering from CTD more quickly. Knowledge about the role of capillaroscopy in UCTD is more limited. It is established that a significant proportion of patients with UCTD present abnormalities on UCTD present non-specific abnormalities and 11% present a scleroderma pattern. In these patients, abnormal capillaroscopy seems to increase the risk of progressing to a better characterized CTD, notably SSc. However, although capillaroscopy is increasingly used in rheumatology in patients with CTD, more research is needed to clarify the role of this examination in UCTD. First, it is not established whether capillaroscopy should be performed in all patients with UCTD, nor when exactly it should be performed. There also remain questions about the impact of capillaroscopy on the prognosis and management of patients with this disease. To our knowledge, there is no prospective study that has addressed this question. The investigators hypothesize that in patients with UCTD, capillaroscopy compared to usual care makes it possible to increase the proportion of patients obtaining a diagnosis of better characterized CTD in the first six months of follow-up.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.