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This study aims to compare two different external calf compression devices applied in healthy individuals. These devices are commonly used in medical care in order to prevent the formation of blood clots, for example during immobilization after surgery. We aim to confirm the effects of external cyclic compression on healing and blood clotting and also to identify the one which is more effective.
Aims:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid calf-IPC | Active Comparator | Cyclic external compression in both calves through a cuff connected to VenaFlow® Elite System, DJO, CA, USA |
|
| subjects under slow calf-IPC | Active Comparator | Cyclic external compression in both calves through a cuff connected to Kendall SCDâ„¢ 700, Covidien, Medtronic, USA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Pneumatic Compression, Rapid | Device | Cyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a sharp and rapid way |
| Measure | Description | Time Frame |
|---|---|---|
| systemic coagulation status | serum levels of coagulation factors (vWF, tPA, PAI-1, Factor VIIa, TFPI, D-dimer) | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| local metabolic activity | Measurement of tissue metabolic products (eg pyruvate) from diffusate extracted with microdialysis in the Achilles paratenon. | 2 hours |
| collagen production | Measurement of collagen from diffusate obtained with microdialysis in the Achilles paratenon. |
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Inclusion Criteria:
Exclusion Criteria:
Only men are being enrolled in order to avoid possible cyclical hormonal influences on blood flow
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| Name | Affiliation | Role |
|---|---|---|
| Paul Ackermann | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska university Hospital | Stockholm | 17176 | Sweden |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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There are two different intervension devices planned to be used in each research subject.
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| Intermittent Pneumatic Compression, Slow | Device | Cyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a smooth, slow and progressive way |
|
| 2 hours |
| regional microcirculation | Mixed oxygen tissue saturation is continuously measured in the lower leg with infrared spectroscopy | 2.5 hours |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |