Effects of External Leg Compression Devices on Healing and Blood Clotting

Not Applicable

• Conditions: Deep Venous Thrombosis; Healing Wound; Venous Stasis
• Interventions: Device: Intermittent Pneumatic Compression, Slow; Device: Intermittent Pneumatic Compression, Rapid

• Registration Number: NCT03050671
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-01-18
• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
subjects under slow calf-IPC	Intermittent Pneumatic Compression, Slow	Cyclic external compression in both calves through a cuff connected to Kendall SCD™ 700, Covidien, Medtronic, USA
Rapid calf-IPC	Intermittent Pneumatic Compression, Rapid	Cyclic external compression in both calves through a cuff connected to VenaFlow® Elite System, DJO, CA, USA

Primary Outcome Measures

Name	Time	Method
systemic coagulation status	2 hours	serum levels of coagulation factors (vWF, tPA, PAI-1, Factor VIIa, TFPI, D-dimer)

Secondary Outcome Measures

Name	Time	Method
local metabolic activity	2 hours	Measurement of tissue metabolic products (eg pyruvate) from diffusate extracted with microdialysis in the Achilles paratenon.
regional microcirculation	2.5 hours	Mixed oxygen tissue saturation is continuously measured in the lower leg with infrared spectroscopy
collagen production	2 hours	Measurement of collagen from diffusate obtained with microdialysis in the Achilles paratenon.

Trial Locations

Locations (1)

Karolinska university Hospital; 🇸🇪 Stockholm, Sweden