MicrocirculationLACOMNCT04660162
Comparison of Laser Speckle Contrast Imaging and Laser Doppler Imaging
A study testing Iontophoresis and Stepwise occlusion in people with Microcirculation, run by Maasstad Hospital at 1 site in Netherlands.
Trial summary
The microcirculation plays a fundamental role in metabolic reactions and has been shown as an essential determinant in many clinical scenarios such as shock states, chronic and cardio-metabolic diseases. Microcirculation can be assessed directly using laser-based techniques and intravital microscopes. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Microcirculation
- What is being tested?
- Iontophoresis and Stepwise occlusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Dec 2018to 17 Dec 2018
- Phase
- Interventional
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Should not have any disease at the time of procedure (including flu)
- Should not have any chronic disease
- Should not be under any medication
- Should not be smoker or ex-smoker
- Should not drink coffee or eat meal in two hours before the procedure
- Should not have an allergy to sodium-nitroprusside
Who cannot join
- Volunteer who does not meet any of the criteria above
- <18 years old
- Pregnant
- Refusal to participate in the study or demand to end study for any reason
- Hypersensitivity to sodium nitroprusside
- Broken or damaged skin surfaces
- Electrically-sensitive implanted devices such as cardiac pacemakers
- Maastad Ziekenhuis employers or collegues
Trial locations and contacts
1 site in 1 country.
About this study
The microcirculation plays a fundamental role in metabolic reactions and has been shown as an essential determinant in many clinical scenarios such as shock states, chronic and cardio-metabolic diseases. Microcirculation can be assessed directly using laser-based techniques and intravital microscopes. When combined with provocation tests, microvascular monitorization can be used to assess microvascular function.
Laser-based techniques are consist of two different methods named laser doppler imaging (LDI), laser speckle contrast imaging (LSCI). LSCI is a technique based on speckle contrast analysis that provides an index of blood flux. No need for skin contact, continuous and real-time assessment of the microcirculation led the LSCI to be broadly used in clinical practice. LDI is also a non-invasive diagnostic method used to measure the blood flux of tissue. The technique is based on measuring the doppler shift induced by moving red blood cells to the illuminating coherent light. Iontophoresis is one of the most commonly used provocation tests to study the endothelium in terms of endothelium-dependent and endothelium-independent vasodilation. Simultaneously with LDI and LSCI are used to follow and assess the skin blood flux during iontophoresis. Therefore, it provides a state to make a comparison between two different laser-based techniques in terms of flux characteristics.
The accurate assessment of burn depth is a critical step in the management of the burn-injured patient. Currently, LDI is the most widely used non-invasive measurement tool for assessing burn wounds and the only technique approved by the U.S. Food and Drug Administration. However, the LDI device is rather costly, cumbersome, and has a poor spatial resolution. LSCI measures perfusion in a similar way, but it provides high-quality images with a much higher spatial resolution. In addition, LSCI is much quicker, maneuverable, and able to assess larger skin areas. In order to use the LSCI technique in the clinical practice of burn-injured patients, as a first step, the linearity of LDI and LSCI should be shown. In this study, we aimed to compare LSCI and LDI with iontophoresis and stepwise occlusion technique. So, we will test the linearity of devices over a large range of blood flux values.
Read the detailed description
Measurements of microcirculation were initiated upon the ethical consent was approved. 15 healthy volunteer were included in the study. All volunteers were asked for the existence of any symptoms for the on-going disease like flu, infectious disease, and chronic disease (Diabetes, hypertension, rheumatologic disorders, epileptic disorders, etc.). Once the volunteer met inclusion criteria, he/she became eligible for study. Volunteers were advised to beware from food and drink for at least two hours before measurement. Also, they were advised to come at least two hours after big meals like lunch or dinner. All the volunteers were evaluated at the same position (sitting and hand at heart level), room and temperature to provide equal standards. The volunteer had rest for at least 30 minutes in a semi-recumbent and extending leg position. The room temperature was 24-26C and checked with a thermometer intermittently. The door was closed to prevent air movement. Lights were switched off, and the curtains were closed to prevent the effect of light on devices. Once all the environmental conditions met, two investigators evaluated the volunteer. One investigator checked the volunteer's blood pressure, temperature, and heart rate.
A vacuum pillow was used to hold the arm stable during the procedure. Two different devices (laser speckle contrast imaging (LSCI) and laser doppler imaging (LDI)) were ready next to the volunteer. An appropriate intact skin area, inner side of the forearm were used for the investigation and both electrodes were attached. The skin surface was cleaned with alcohol or deionized water to remove remnants of cosmetics and creams with low conductivity. This helped to prevent spots with high current density that may result in local burns and non-specific vascular reactions. After peeling off the protective tape layer on the bottom of the Drug Delivery Electrode, the electrode was firmly attached to the skin. The Dispersive Electrode was placed approximately 10-15 cm from the Drug Delivery Electrode. Power supply was connected by attaching the electrodes to the leads. After lifting the lid of the Drug Delivery Electrode using the pointed tab, tip of the syringe was slided under the lid of the Drug Delivery Electrode and the Drug Delivery Chamber was filled with approximately 0.5 mL of a 10 mg/ml SNP solution. The drug was then delivered using cathodal iontophoresis for 1 minute with a current strength of 200 µA. The LDI and LSCI instruments are positioned so they can alternately measure the delivery site. Basal perfusion was measured with both instruments before starting iontophoresis. Subsequently, iontophoresis was started and measurements are made alternating between the two instruments. Therefore, we would be able to compare both devices in terms of supra-baseline flux values. When all measurements were finished, the electrodes removed from the patient and the Drug Delivery Electrode and the Dispersive Electrode was removed.
The second part of the study was performed as step-wise occlusion. The arm which was not used for iontophoresis test was used for step-wise occlusion. The baseline blood flux was followed for 2 minutes by LDI and LSCI. After 2 minutes, the upper arm was occluded for 30 seconds with a pneumatic cuff up to 50 mmHg, 80 mmHg, 110 mmHg, 140 mmHg, and 170 mmHg. Between each part, the volunteer had rest for 5 minutes to let the blood flux to turn the baseline. Once reaching to the planned pressure, LSCI and LDI devices were alternately be used to record blood flux. Therefore, we were able to compare both devices in terms of sub-baseline flux values.
All data were recorded in 2 external electronic storage, and the names of the volunteers were coded with numbers. Only main investigator was aware of who corresponds to which number. Results of Perimed and Moore Devices were analyzed with the software PIMsoft 1.5 (Perimed AB, Järfälla, Sweden), MoorLDI2-BI Burn's Software Version 4.0, respectively. Two investigators performed the analysis. If one investigator made the analysis, the other checked the results, as well.
- Conditions
- Microcirculation
- Being tested
- Iontophoresis, Stepwise occlusion
- Keywords
- microcirculation, laser speckle contrast imaging, laser doppler perfusion imaging, iontophoresis, comparison, flux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IontophoresisDevice
By using the PeriIont (Perimed, Jarfalla, Sweden) device, 0.5 mL of a 10 mg/ml Sodium nitroprusside solution was used transdermally and ionised with a current strength of 200 µA for 1 minute.
Stepwise occlusionOther
The upper arm was occluded for 30 seconds with a pneumatic cuff up to 50 mmHg, 80 mmHg, 110 mmHg, 140 mmHg, and 170 mmHg. The volunteer had rest for 5 minutes between each occlusion procedure.
| Study group | Role | What they receive |
|---|---|---|
| Arm-1: Laser speckle contrast imaging | Experimental | (Perimed AB, Järfälla, Sweden) Receives: Device: Iontophoresis; Other: Stepwise occlusion |
| Arm-2: Laser Doppler perfusion imaging | Experimental | (Moor Instruments, Devon, UK) Receives: Device: Iontophoresis; Other: Stepwise occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Laser Speckle Contrast Imaging and Laser Doppler Imaging
Blood flux values of Laser Speckle Contrast Imaging device (Perimed AB, Järfälla, Sweden) and Laser Doppler Imaging device (Moor Instruments, Devon, UK) will be measured in a wide range of blood flux values and an equation formula will be described
Measured: 60 minutes
Secondary outcomes (2)
Creating common unit for Laser Speckle Contrast Imaging and Laser Doppler Imaging
Blood flux units will be measured and A new common and universal unit for laser based tecniques will be reported
Measured: 60 minutes
Creating common color map for Laser Speckle Contrast Imaging and Laser Doppler Imaging
A new universal color code that is used by both Laser Doppler perfusion imaging and Laser speckle contrast imaging will be created based on the equation formula
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start10 Dec 2018
- Primary completion17 Dec 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for MicrocirculationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maasstad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goksel Guven, Maasstad Hospital
- Investigators
- Kees vd Vlies, MD, Study director, Maasstad Hospital, Department of Burn CareCan Ince, Phd, Study director, Erasmus Medical Center, Department of Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660162
- Sponsor's protocol ID
- NL65747.101.18
- Acronym
- LACOM
- Status last verified
- Mar 2023
- First submitted
- 22 Nov 2020
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sakr Y. Techniques to assess tissue oxygenation in the clinical setting. Transfus Apher Sci. 2010 Aug;43(1):79-94. doi: 10.1016/j.transci.2010.05.012. Epub 2010 Jun 17.
PubMed 20692624Briers JD. Laser Doppler, speckle and related techniques for blood perfusion mapping and imaging. Physiol Meas. 2001 Nov;22(4):R35-66. doi: 10.1088/0967-3334/22/4/201.
PubMed 11761081Tew GA, Klonizakis M, Crank H, Briers JD, Hodges GJ. Comparison of laser speckle contrast imaging with laser Doppler for assessing microvascular function. Microvasc Res. 2011 Nov;82(3):326-32. doi: 10.1016/j.mvr.2011.07.007. Epub 2011 Jul 22.
PubMed 21803051Stewart CJ, Frank R, Forrester KR, Tulip J, Lindsay R, Bray RC. A comparison of two laser-based methods for determination of burn scar perfusion: laser Doppler versus laser speckle imaging. Burns. 2005 Sep;31(6):744-52. doi: 10.1016/j.burns.2005.04.004.
PubMed 16129229Millet C, Roustit M, Blaise S, Cracowski JL. Comparison between laser speckle contrast imaging and laser Doppler imaging to assess skin blood flow in humans. Microvasc Res. 2011 Sep;82(2):147-51. doi: 10.1016/j.mvr.2011.06.006. Epub 2011 Jul 1.
PubMed 21745482Cordovil I, Huguenin G, Rosa G, Bello A, Kohler O, de Moraes R, Tibirica E. Evaluation of systemic microvascular endothelial function using laser speckle contrast imaging. Microvasc Res. 2012 May;83(3):376-9. doi: 10.1016/j.mvr.2012.01.004. Epub 2012 Jan 31.
PubMed 22326551Tesselaar E, Sjoberg F. Transdermal iontophoresis as an in-vivo technique for studying microvascular physiology. Microvasc Res. 2011 Jan;81(1):88-96. doi: 10.1016/j.mvr.2010.11.002. Epub 2010 Nov 9.
PubMed 21070791Wearn C, Lee KC, Hardwicke J, Allouni A, Bamford A, Nightingale P, Moiemen N. Prospective comparative evaluation study of Laser Doppler Imaging and thermal imaging in the assessment of burn depth. Burns. 2018 Feb;44(1):124-133. doi: 10.1016/j.burns.2017.08.004. Epub 2017 Oct 9.
PubMed 29032974Iredahl F, Lofberg A, Sjoberg F, Farnebo S, Tesselaar E. Non-Invasive Measurement of Skin Microvascular Response during Pharmacological and Physiological Provocations. PLoS One. 2015 Aug 13;10(8):e0133760. doi: 10.1371/journal.pone.0133760. eCollection 2015.
PubMed 26270037Ince C. The microcirculation is the motor of sepsis. Crit Care. 2005;9 Suppl 4(Suppl 4):S13-9. doi: 10.1186/cc3753. Epub 2005 Aug 25.
PubMed 16168069Klijn E, Den Uil CA, Bakker J, Ince C. The heterogeneity of the microcirculation in critical illness. Clin Chest Med. 2008 Dec;29(4):643-54, viii. doi: 10.1016/j.ccm.2008.06.008.
PubMed 18954699
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laser Speckle Contrast Imaging and Laser Doppler Imaging
- ClinicalTrials.gov ID
- NCT04660162
- Acronym / sponsor ID
- LACOM / NL65747.101.18
- Conditions
- Microcirculation
- Keywords
- microcirculation, laser speckle contrast imaging, laser doppler perfusion imaging, iontophoresis, comparison, flux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maasstad HospitalUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 9 Dec 2020 (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.
The microcirculation plays a fundamental role in metabolic reactions and has been shown as an essential determinant in many clinical scenarios such as shock states, chronic and cardio-metabolic diseases. Microcirculation can be assessed directly using laser-based techniques and intravital microscopes. When combined with provocation tests, microvascular monitorization can be used to assess microvascular function.
Laser-based techniques are consist of two different methods named laser doppler imaging (LDI), laser speckle contrast imaging (LSCI). LSCI is a technique based on speckle contrast analysis that provides an index of blood flux. No need for skin contact, continuous and real-time assessment of the microcirculation led the LSCI to be broadly used in clinical practice. LDI is also a non-invasive diagnostic method used to measure the blood flux of tissue. The technique is based on measuring the doppler shift induced by moving red blood cells to the illuminating coherent light. Iontophoresis is one of the most commonly used provocation tests to study the endothelium in terms of endothelium-dependent and endothelium-independent vasodilation. Simultaneously with LDI and LSCI are used to follow and assess the skin blood flux during iontophoresis. Therefore, it provides a state to make a comparison between two different laser-based techniques in terms of flux characteristics.
The accurate assessment of burn depth is a critical step in the management of the burn-injured patient. Currently, LDI is the most widely used non-invasive measurement tool for assessing burn wounds and the only technique approved by the U.S. Food and Drug Administration. However, the LDI device is rather costly, cumbersome, and has a poor spatial resolution. LSCI measures perfusion in a similar way, but it provides high-quality images with a much higher spatial resolution. In addition, LSCI is much quicker, maneuverable, and able to assess larger skin areas. In order to use the LSCI technique in the clinical practice of burn-injured patients, as a first step, the linearity of LDI and LSCI should be shown. In this study, we aimed to compare LSCI and LDI with iontophoresis and stepwise occlusion technique. So, we will test the linearity of devices over a large range of blood flux values.
Detailed description
Measurements of microcirculation were initiated upon the ethical consent was approved. 15 healthy volunteer were included in the study. All volunteers were asked for the existence of any symptoms for the on-going disease like flu, infectious disease, and chronic disease (Diabetes, hypertension, rheumatologic disorders, epileptic disorders, etc.). Once the volunteer met inclusion criteria, he/she became eligible for study. Volunteers were advised to beware from food and drink for at least two hours before measurement. Also, they were advised to come at least two hours after big meals like lunch or dinner. All the volunteers were evaluated at the same position (sitting and hand at heart level), room and temperature to provide equal standards. The volunteer had rest for at least 30 minutes in a semi-recumbent and extending leg position. The room temperature was 24-26C and checked with a thermometer intermittently. The door was closed to prevent air movement. Lights were switched off, and the curtains were closed to prevent the effect of light on devices. Once all the environmental conditions met, two investigators evaluated the volunteer. One investigator checked the volunteer's blood pressure, temperature, and heart rate.
A vacuum pillow was used to hold the arm stable during the procedure. Two different devices (laser speckle contrast imaging (LSCI) and laser doppler imaging (LDI)) were ready next to the volunteer. An appropriate intact skin area, inner side of the forearm were used for the investigation and both electrodes were attached. The skin surface was cleaned with alcohol or deionized water to remove remnants of cosmetics and creams with low conductivity. This helped to prevent spots with high current density that may result in local burns and non-specific vascular reactions. After peeling off the protective tape layer on the bottom of the Drug Delivery Electrode, the electrode was firmly attached to the skin. The Dispersive Electrode was placed approximately 10-15 cm from the Drug Delivery Electrode. Power supply was connected by attaching the electrodes to the leads. After lifting the lid of the Drug Delivery Electrode using the pointed tab, tip of the syringe was slided under the lid of the Drug Delivery Electrode and the Drug Delivery Chamber was filled with approximately 0.5 mL of a 10 mg/ml SNP solution. The drug was then delivered using cathodal iontophoresis for 1 minute with a current strength of 200 µA. The LDI and LSCI instruments are positioned so they can alternately measure the delivery site. Basal perfusion was measured with both instruments before starting iontophoresis. Subsequently, iontophoresis was started and measurements are made alternating between the two instruments. Therefore, we would be able to compare both devices in terms of supra-baseline flux values. When all measurements were finished, the electrodes removed from the patient and the Drug Delivery Electrode and the Dispersive Electrode was removed.
The second part of the study was performed as step-wise occlusion. The arm which was not used for iontophoresis test was used for step-wise occlusion. The baseline blood flux was followed for 2 minutes by LDI and LSCI. After 2 minutes, the upper arm was occluded for 30 seconds with a pneumatic cuff up to 50 mmHg, 80 mmHg, 110 mmHg, 140 mmHg, and 170 mmHg. Between each part, the volunteer had rest for 5 minutes to let the blood flux to turn the baseline. Once reaching to the planned pressure, LSCI and LDI devices were alternately be used to record blood flux. Therefore, we were able to compare both devices in terms of sub-baseline flux values.
All data were recorded in 2 external electronic storage, and the names of the volunteers were coded with numbers. Only main investigator was aware of who corresponds to which number. Results of Perimed and Moore Devices were analyzed with the software PIMsoft 1.5 (Perimed AB, Järfälla, Sweden), MoorLDI2-BI Burn's Software Version 4.0, respectively. Two investigators performed the analysis. If one investigator made the analysis, the other checked the results, as well.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm-1: Laser speckle contrast imaging | Experimental | Device: Iontophoresis, Other: Stepwise occlusion(Perimed AB, Järfälla, Sweden) |
| Arm-2: Laser Doppler perfusion imaging | Experimental | Device: Iontophoresis, Other: Stepwise occlusion(Moor Instruments, Devon, UK) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Should not have any disease at the time of procedure (including flu)
- Should not have any chronic disease
- Should not be under any medication
- Should not be smoker or ex-smoker
- Should not drink coffee or eat meal in two hours before the procedure
Key exclusion criteria (8 listed)
- Volunteer who does not meet any of the criteria above
- <18 years old
- Pregnant
- Refusal to participate in the study or demand to end study for any reason
- Hypersensitivity to sodium nitroprusside
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 |
|---|---|---|
| IontophoresisBy using the PeriIont (Perimed, Jarfalla, Sweden) device, 0.5 mL of a 10 mg/ml Sodium nitroprusside solution was used transdermally and ionised with a current strength of 200 µA for 1 minute. | Device | Arm-1: Laser speckle contrast imaging, Arm-2: Laser Doppler perfusion imaging |
| Stepwise occlusionThe upper arm was occluded for 30 seconds with a pneumatic cuff up to 50 mmHg, 80 mmHg, 110 mmHg, 140 mmHg, and 170 mmHg. The volunteer had rest for 5 minutes between each occlusion procedure. | Other | Arm-1: Laser speckle contrast imaging, Arm-2: Laser Doppler perfusion imaging |
Primary outcome
Comparison of Laser Speckle Contrast Imaging and Laser Doppler Imaging
Time frame: 60 minutes
Blood flux values of Laser Speckle Contrast Imaging device (Perimed AB, Järfälla, Sweden) and Laser Doppler Imaging device (Moor Instruments, Devon, UK) will be measured in a wide range of blood flux values and an equation formula will be described
2 secondary outcomes
Creating common unit for Laser Speckle Contrast Imaging and Laser Doppler Imaging
Time frame: 60 minutes
Creating common color map for Laser Speckle Contrast Imaging and Laser Doppler Imaging
Time frame: 60 minutes
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 17 Mar 2023.
- Background: PubMed 20692624Sakr Y. Techniques to assess tissue oxygenation in the clinical setting. Transfus Apher Sci. 2010 Aug;43(1):79-94. doi: 10.1016/j.transci.2010.05.012. Epub 2010 Jun 17.
- Background: PubMed 11761081Briers JD. Laser Doppler, speckle and related techniques for blood perfusion mapping and imaging. Physiol Meas. 2001 Nov;22(4):R35-66. doi: 10.1088/0967-3334/22/4/201.
- Background: PubMed 21803051Tew GA, Klonizakis M, Crank H, Briers JD, Hodges GJ. Comparison of laser speckle contrast imaging with laser Doppler for assessing microvascular function. Microvasc Res. 2011 Nov;82(3):326-32. doi: 10.1016/j.mvr.2011.07.007. Epub 2011 Jul 22.
- Background: PubMed 16129229Stewart CJ, Frank R, Forrester KR, Tulip J, Lindsay R, Bray RC. A comparison of two laser-based methods for determination of burn scar perfusion: laser Doppler versus laser speckle imaging. Burns. 2005 Sep;31(6):744-52. doi: 10.1016/j.burns.2005.04.004.
- Background: PubMed 21745482Millet C, Roustit M, Blaise S, Cracowski JL. Comparison between laser speckle contrast imaging and laser Doppler imaging to assess skin blood flow in humans. Microvasc Res. 2011 Sep;82(2):147-51. doi: 10.1016/j.mvr.2011.06.006. Epub 2011 Jul 1.
- Background: PubMed 22326551Cordovil I, Huguenin G, Rosa G, Bello A, Kohler O, de Moraes R, Tibirica E. Evaluation of systemic microvascular endothelial function using laser speckle contrast imaging. Microvasc Res. 2012 May;83(3):376-9. doi: 10.1016/j.mvr.2012.01.004. Epub 2012 Jan 31.
- Background: PubMed 21070791Tesselaar E, Sjoberg F. Transdermal iontophoresis as an in-vivo technique for studying microvascular physiology. Microvasc Res. 2011 Jan;81(1):88-96. doi: 10.1016/j.mvr.2010.11.002. Epub 2010 Nov 9.
- Background: PubMed 29032974Wearn C, Lee KC, Hardwicke J, Allouni A, Bamford A, Nightingale P, Moiemen N. Prospective comparative evaluation study of Laser Doppler Imaging and thermal imaging in the assessment of burn depth. Burns. 2018 Feb;44(1):124-133. doi: 10.1016/j.burns.2017.08.004. Epub 2017 Oct 9.
- Background: PubMed 26270037Iredahl F, Lofberg A, Sjoberg F, Farnebo S, Tesselaar E. Non-Invasive Measurement of Skin Microvascular Response during Pharmacological and Physiological Provocations. PLoS One. 2015 Aug 13;10(8):e0133760. doi: 10.1371/journal.pone.0133760. eCollection 2015.
- Results publication: PubMed 16168069Ince C. The microcirculation is the motor of sepsis. Crit Care. 2005;9 Suppl 4(Suppl 4):S13-9. doi: 10.1186/cc3753. Epub 2005 Aug 25.
- Results publication: PubMed 18954699Klijn E, Den Uil CA, Bakker J, Ince C. The heterogeneity of the microcirculation in critical illness. Clin Chest Med. 2008 Dec;29(4):643-54, viii. doi: 10.1016/j.ccm.2008.06.008.
- Individual participant dataSharing planned: Undecided
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.
Kees vd Vlies, MD study director
Maasstad Hospital, Department of Burn Care
Can Ince, Phd study director
Erasmus Medical Center, Department of Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iontophoresis and Stepwise occlusion in people with Microcirculation, run by Maasstad Hospital at 1 site in Netherlands.
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 6 inclusion and 8 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 17 Mar 2023. 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 Netherlands. 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?
Comparison of Laser Speckle Contrast Imaging and Laser Doppler Imaging (time frame: 60 minutes). 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 NCT04660162, which also lists 11 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 17 Mar 2023.