Effects of External Leg Compression Devices on Healing and Blood Clotting

Intermittent Pneumatic Compression in the Lower Limbs: Systemic and Local Effects in Coagulation Status, Microcirculation, Tissue Metabolic Activity and Collagen Production.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healing Wound; Venous Stasis; Deep Venous Thrombosis
• Intervention / Treatment: Device: Intermittent Pneumatic Compression, Rapid; Device: Intermittent Pneumatic Compression, Slow

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systemic coagulation status	serum levels of coagulation factors (vWF, tPA, PAI-1, Factor VIIa, TFPI, D-dimer)	2 hours

Secondary Outcome Measures

Outcome Measure	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.	2 hours
regional microcirculation	Mixed oxygen tissue saturation is continuously measured in the lower leg with infrared spectroscopy	2.5 hours

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Investigators: Principal Investigator: Paul Ackermann, Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2017
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Embolism and Thrombosis; Varicose Veins; Thrombosis; Venous Thrombosis; Varicose Ulcer
• Other Study ID Numbers: SW2017-01-COAGMET

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No