MicrocirculationSpeckleShakeNCT01169974
Use of Laser Speckle to Study Post Occlusive Reactive Hyperhemia in Healthy Subjects
An observational study of Microcirculation, run by University Hospital, Angers at 1 site in France.
Trial summary
The investigators aim to test the hypothesis that Laser speckle contrast imaging allows for the measurement of cutaneous blood flow following various durations of tourniquet ischemia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microcirculation
- What is being tested?
- tourniquet ischemia
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2011to 4 Dec 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volunteers
Who may be able to join
- Healthy volunteers
- Affiliation to the French health system
Who cannot join
- Any disease or chronic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Chez Des Sujets Volontaires Sains de l'ischémie-reperfusion cutanée
The investigators aim to test the hypothesis that Laser speckle contrast imaging allows for the measurement of cutaneous blood flow following various durations of tourniquet ischemia.
Read the detailed description
Ischemia and post occlusive reactive hyperemia in the skin is tested in healthy normal subjects for tourniquet ischemias of 1, 2 \& 3 minutes at rest.
- Conditions
- Microcirculation
- Being tested
- tourniquet ischemia
- Keywords
- Microcirculation, laser flowmetry, Skin, Physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tourniquet ischemiaOther
Also called Laser doppler flowmetry, Transcutaneous oxygen pressure, Near infra-red spectrometry, Plethysmography
Recording of cutaneous blood flow on the forearm at rest before and following tourniquet ischemias of 1 , 2 \& 3 minutes
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Not described Receives: Other: tourniquet ischemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laser speckle
Peak value of laser speckle signal
Measured: with 2 minutes of ischemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study start1 Feb 2011
- Primary completionSep 2012
- Study completion4 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrocirculationStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Guillaume Mahe, Principal investigator, University Hospital in Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169974
- Sponsor's protocol ID
- CHU P 2010-18
- Acronym
- SpeckleShake
- Status last verified
- Oct 2017
- First submitted
- 23 Jul 2010
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Chez Des Sujets Volontaires Sains de l'ischémie-reperfusion cutanée
- ClinicalTrials.gov ID
- NCT01169974
- Acronym / sponsor ID
- SpeckleShake / CHU P 2010-18
- Conditions
- Microcirculation
- Keywords
- Microcirculation, laser flowmetry, Skin, Physiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- Sep 2012 (actual)
- Study completion
- 4 Dec 2012 (actual)
- First posted
- 26 Jul 2010 (estimated)
- 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.
The investigators aim to test the hypothesis that Laser speckle contrast imaging allows for the measurement of cutaneous blood flow following various durations of tourniquet ischemia.
Detailed description
Ischemia and post occlusive reactive hyperemia in the skin is tested in healthy normal subjects for tourniquet ischemias of 1, 2 \& 3 minutes at rest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Other: tourniquet ischemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volunteers
Key inclusion criteria (2 listed)
- Healthy volunteers
- Affiliation to the French health system
Key exclusion criteria (1 listed)
- Any disease or chronic treatment
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 |
|---|---|---|
| tourniquet ischemiaAlso: Laser doppler flowmetry, Transcutaneous oxygen pressure, Near infra-red spectrometry, PlethysmographyRecording of cutaneous blood flow on the forearm at rest before and following tourniquet ischemias of 1 , 2 \& 3 minutes | Other | healthy volunteers |
Primary outcome
Laser speckle
Time frame: with 2 minutes of ischemia
Peak value of laser speckle signal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
Related trials for Microcirculation
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Not yet recruitingObservational study
Vascular Aging and Microcirculation: Physiological Aspects of Vascular Aging in the Elderly Population (VAMP-Aging)
Aging Problems
RecruitingObservational study
Hemodynamic Evaluation and Assessment of DIRECT myocaRdial and Sublingual Capillary Perfusion in Thoracic Surgery Patients on Cardiopulmonary Bypass
Microcirculatory Perfusion
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Recruiting
Study on the Improvement of Myocardial Microcirculation After Acute Anterior Myocardial Infarction
Intravascular Imaging and Microvascular Obstruction
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.
Guillaume Mahe principal investigator
University Hospital in Angers
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 Microcirculation, run by University Hospital, Angers at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 1 Nov 2017. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laser speckle (time frame: with 2 minutes of ischemia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2017.