Effects of External Leg Compression Devices on Healing and Blood Clotting
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|ClinicalTrials.gov Identifier: NCT03050671|
Recruitment Status : Enrolling by invitation
First Posted : February 13, 2017
Last Update Posted : September 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Venous Stasis Deep Venous Thrombosis Healing Wound||Device: Intermittent Pneumatic Compression, Rapid Device: Intermittent Pneumatic Compression, Slow||Not Applicable|
- To confirm that IPC (intermittent pneumatic compression) has a positive effect on systemic coagulation status, tissue metabolic activity, collagen formation and tissue microcirculation.
- To compare the above effect of two different IPC devices: one rapid calf-IPC which expels blood from the veins sharp and rapidly and one slow calf-IPC, which pumps the blood in a more gentle and progressive way. This study could also make implications on how the blood flow parameters could be interpreted in the clinical setting, as previous haemodynamic studies have explained the superiority of the rapid device in terms of peak velocity and the superiority of the slow device in terms of total ejected volume per individual stimulus.
Materials and Methods: 10-15 healthy individuals are planned to be recruited. The subjects will be lying in a prone position. A cuff connected with a Calf-IPC device will be wrapped around each calf and will be functioning for 120 minutes. Microdialysis catheters will be inserted with the tips about 1 mm from the volar side of each Achilles tendon. In addition, one adhesive sensor will be applied on each calf just distal to the lower part of the cuff, in order to measure tissue oxygen mixed saturation (INVOS). Blood samples will be taken via a venous catheter in antecubital fossa just before the application of the IPC, and at 30, 60 and 120 minutes. From the serum, several systemic coagulation factors will be measured (tissue plasminogen activator (tPA), plasminogen activator inhibitor type 1 (PAI), tissue factor pathway inhibitor (TFPI), D-dimer, von Willebrand factor and factor VIIa). From the microdialysis diffusate , two groups of substances will be measured: a) metabolites, such as pyruvate and b) collagen macromolecules, such as procollagen type I and III.
The ultimate goal is to assess the role of different IPC patterns on deep venous thrombosis prevention and promotion of tissue healing.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||There are two different intervension devices planned to be used in each research subject.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Intermittent Pneumatic Compression in the Lower Limbs: Systemic and Local Effects in Coagulation Status, Microcirculation, Tissue Metabolic Activity and Collagen Production.|
|Actual Study Start Date :||January 18, 2017|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||August 1, 2022|
Active Comparator: Rapid calf-IPC
Cyclic external compression in both calves through a cuff connected to VenaFlow® Elite System, DJO, CA, USA
Device: Intermittent Pneumatic Compression, Rapid
Cyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a sharp and rapid way
Active Comparator: subjects under slow calf-IPC
Cyclic external compression in both calves through a cuff connected to Kendall SCD™ 700, Covidien, Medtronic, USA
Device: Intermittent Pneumatic Compression, Slow
Cyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a smooth, slow and progressive way
- systemic coagulation status [ Time Frame: 2 hours ]serum levels of coagulation factors (vWF, tPA, PAI-1, Factor VIIa, TFPI, D-dimer)
- local metabolic activity [ Time Frame: 2 hours ]Measurement of tissue metabolic products (eg pyruvate) from diffusate extracted with microdialysis in the Achilles paratenon.
- collagen production [ Time Frame: 2 hours ]Measurement of collagen from diffusate obtained with microdialysis in the Achilles paratenon.
- regional microcirculation [ Time Frame: 2.5 hours ]Mixed oxygen tissue saturation is continuously measured in the lower leg with infrared spectroscopy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050671
|Karolinska university Hospital|
|Stockholm, Sweden, 17176|
|Principal Investigator:||Paul Ackermann||Karolinska University Hospital|