NCT01743612

Brief Summary

The aim of the study is to determine if postocclusive hyperemia of palmar and dorsal face of the hand with Laser speckle contrast imaging discriminate between patients with systemic sclerosis, subjects with primary Raynaud's phenomenon and healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 2, 2016

Status Verified

December 1, 2015

Enrollment Period

3.4 years

First QC Date

December 4, 2012

Last Update Submit

June 1, 2016

Conditions

Raynaud DiseaseScleroderma, Systemic

Keywords

healthy subjecthand blood flowlaser speckle contrast imaging

Outcome Measures

Primary Outcomes (1)

  • Post-occlusive hyperemia response between groups

    The range of post-occlusive hyperemia response will be compared between the 3 arms.

    30 minutes

Secondary Outcomes (4)

  • post-occlusive hyperemia response between zones

    30 minutes

  • abnormal post-occlusive hyperemia response and finger pad scars

    30 minutes

  • Entropy and Fourier transform

    30 minutes

  • Post-occlusive hyperemia response between the 2 faces

    30 minutes

Other Outcomes (3)

  • Blood flow after cooling between groups

    30 minutes

  • reproductibility of hand cooling

    Day 0 and Day 4

  • blood flow after cooling in each group

    30 minutes

Study Arms (3)

Sclerodermic patients

EXPERIMENTAL

patients with systemic sclerosis according to Leroy's classification

Procedure: laser speckle contrast imagingProcedure: Cooling

Primary Raynaud's phenomenon

EXPERIMENTAL

without secondary disease

Procedure: laser speckle contrast imagingProcedure: Cooling

Healthy subjects

EXPERIMENTAL

18 years old or more

Procedure: laser speckle contrast imagingProcedure: Cooling

Interventions

laser speckle contrast imagingPROCEDURE

blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.

Healthy subjectsPrimary Raynaud's phenomenonSclerodermic patients
CoolingPROCEDURE

blood flow of the hand recording during 30 minutes in a cooling-box

Healthy subjectsPrimary Raynaud's phenomenonSclerodermic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects:
  • Man ou woman 18 years old or more.
  • Without Raynaud's phenomenon or systemic sclerosis.
  • Raynaud's phenomenon subjects:
  • Man ou woman 18 years old or more.
  • with primary Raynaud's phenomenon.
  • Systemic sclerosis:
  • Man ou woman 18 years old or more.
  • systemic sclerosis in accordance to Leroy's classification.

You may not qualify if:

  • active digital ulceration
  • Bosentan, iloprost ou sildenafil treatment
  • History of axillary dissection , trauma or surgery
  • history of thromboembolic disease or thrombophilia
  • minor or law-protected major
  • No affiliation to medicare
  • pregnant, parturient or breasting woman
  • concomitant serious disease: progressive cancer, liver failure, history of myocardial infarction less than 5 years, angor
  • smoking in the 6 last months
  • person deprived of liberty by a legal or administrative decision, person under legal protection
  • maximal annual indemnification reached.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Research Center

Grenoble, 38043, France

Location

Vascular Medical Unit

Grenoble, 38043, France

Location

Related Publications (1)

  • Gaillard-Bigot F, Roustit M, Blaise S, Gabin M, Cracowski C, Seinturier C, Imbert B, Carpentier P, Cracowski JL. Abnormal amplitude and kinetics of digital postocclusive reactive hyperemia in systemic sclerosis. Microvasc Res. 2014 Jul;94:90-5. doi: 10.1016/j.mvr.2014.05.007. Epub 2014 Jun 2.

    PMID: 24990822DERIVED

MeSH Terms

Conditions

Raynaud DiseaseScleroderma, Systemic

Interventions

Laser Speckle Contrast ImagingCool-Down Exercise

Condition Hierarchy (Ancestors)

Livedoid VasculopathyThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesConnective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesPost-Exercise Recovery TechniquesPhysical Therapy ModalitiesTherapeuticsRehabilitationExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jean-Luc CRACOWSKI, MD, PhD

    CIC, CHU Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2012

First Posted

December 6, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 2, 2016

Record last verified: 2015-12

Locations

FR(2)