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Effects of External Leg Compression Devices on Healing and Blood Clotting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050671
Recruitment Status : Enrolling by invitation
First Posted : February 13, 2017
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Paul Ackermann, Karolinska University Hospital

Brief Summary:
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.

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

Detailed Description:

Aims:

  1. To confirm that IPC (intermittent pneumatic compression) has a positive effect on systemic coagulation status, tissue metabolic activity, collagen formation and tissue microcirculation.
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
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 : March 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. systemic coagulation status [ Time Frame: 2 hours ]
    serum levels of coagulation factors (vWF, tPA, PAI-1, Factor VIIa, TFPI, D-dimer)


Secondary Outcome Measures :
  1. local metabolic activity [ Time Frame: 2 hours ]
    Measurement of tissue metabolic products (eg pyruvate) from diffusate extracted with microdialysis in the Achilles paratenon.

  2. collagen production [ Time Frame: 2 hours ]
    Measurement of collagen from diffusate obtained with microdialysis in the Achilles paratenon.

  3. regional microcirculation [ Time Frame: 2.5 hours ]
    Mixed oxygen tissue saturation is continuously measured in the lower leg with infrared spectroscopy



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only men are being enrolled in order to avoid possible cyclical hormonal influences on blood flow
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy individuals
  • Male gender
  • Age 18-60

Exclusion Criteria:

  • Smoking
  • Severe cardiovascular or renal disease causing pitting oedema
  • Previous operation in the lower limbs affecting the vascular or lymphatic system

Information from the National Library of Medicine

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


Locations
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Sweden
Karolinska university Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Paul Ackermann Karolinska University Hospital
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Responsible Party: Paul Ackermann, Paul Ackermann M.D, Ph.D. Associate Professor Specialist in Orthopaedic Surgery Orthopaedic Department, Karolinska University Hospital, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03050671    
Other Study ID Numbers: SW2017-01-COAGMET
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Varicose Ulcer
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases