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Effects of External Leg Compression Devices on Healing and Blood Clotting

Primary Purpose

Venous Stasis, Deep Venous Thrombosis, Healing Wound

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Intermittent Pneumatic Compression, Rapid
Intermittent Pneumatic Compression, Slow
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Venous Stasis

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Karolinska university Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rapid calf-IPC

subjects under slow calf-IPC

Arm Description

Cyclic external compression in both calves through a cuff connected to VenaFlow® Elite System, DJO, CA, USA

Cyclic external compression in both calves through a cuff connected to Kendall SCD™ 700, Covidien, Medtronic, USA

Outcomes

Primary Outcome Measures

systemic coagulation status
serum levels of coagulation factors (vWF, tPA, PAI-1, Factor VIIa, TFPI, D-dimer)

Secondary Outcome Measures

local metabolic activity
Measurement of tissue metabolic products (eg pyruvate) from diffusate extracted with microdialysis in the Achilles paratenon.
collagen production
Measurement of collagen from diffusate obtained with microdialysis in the Achilles paratenon.
regional microcirculation
Mixed oxygen tissue saturation is continuously measured in the lower leg with infrared spectroscopy

Full Information

First Posted
February 9, 2017
Last Updated
October 5, 2023
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03050671
Brief Title
Effects of External Leg Compression Devices on Healing and Blood Clotting
Official Title
Intermittent Pneumatic Compression in the Lower Limbs: Systemic and Local Effects in Coagulation Status, Microcirculation, Tissue Metabolic Activity and Collagen Production.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Aims: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Stasis, Deep Venous Thrombosis, Healing Wound

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
There are two different intervension devices planned to be used in each research subject.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rapid calf-IPC
Arm Type
Active Comparator
Arm Description
Cyclic external compression in both calves through a cuff connected to VenaFlow® Elite System, DJO, CA, USA
Arm Title
subjects under slow calf-IPC
Arm Type
Active Comparator
Arm Description
Cyclic external compression in both calves through a cuff connected to Kendall SCD™ 700, Covidien, Medtronic, USA
Intervention Type
Device
Intervention Name(s)
Intermittent Pneumatic Compression, Rapid
Intervention Description
Cyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a sharp and rapid way
Intervention Type
Device
Intervention Name(s)
Intermittent Pneumatic Compression, Slow
Intervention Description
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 Measure Information:
Title
systemic coagulation status
Description
serum levels of coagulation factors (vWF, tPA, PAI-1, Factor VIIa, TFPI, D-dimer)
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
local metabolic activity
Description
Measurement of tissue metabolic products (eg pyruvate) from diffusate extracted with microdialysis in the Achilles paratenon.
Time Frame
2 hours
Title
collagen production
Description
Measurement of collagen from diffusate obtained with microdialysis in the Achilles paratenon.
Time Frame
2 hours
Title
regional microcirculation
Description
Mixed oxygen tissue saturation is continuously measured in the lower leg with infrared spectroscopy
Time Frame
2.5 hours

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only men are being enrolled in order to avoid possible cyclical hormonal influences on blood flow
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Ackermann
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska university Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

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Effects of External Leg Compression Devices on Healing and Blood Clotting

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