Recruiting

Capillaroscopy

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT06399822

Conditions

Undifferentiated Connective Tissue Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nail capillaroscopy

Study Details

Brief summary:

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.

Conditions

Undifferentiated Connective Tissue Diseases

Study ID

NCT06399822

Start date

May 22, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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 consent or respond to questionnaires.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Capillaroscopy

In the capillaroscopy group, the capillaroscopy will be performed in the month following recruitment.

other: Control

In the control group, the capillaroscopy will be performed six months (+/- 2 weeks) after recruitment.

Interventions

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.

Primary outcome measure

  • Proportion of participants who transitioned from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

CHU de Quebec-Université Laval

Recruiting

Québec, Quebec, Canada, G1V4G2

Contacts

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • undifferentiated connective tissue disease
  • capillaroscopy
  • randomized pilot clinical study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2026-03-17.