Effects of External Leg Compression Devices on Healing and Blood Clotting

Deep Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03050671
• Other study ID #: SW2017-01-COAGMET
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 18, 2017
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Healing Wound
• Thrombosis
• Varicose Ulcer
• Venous Stasis
• Venous Thrombosis

Intervention

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
• 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

Locations

Country	Name	City	State
Sweden	Karolinska university Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systemic coagulation status	serum levels of coagulation factors (vWF, tPA, PAI-1, Factor VIIa, TFPI, D-dimer)	2 hours
Secondary	local metabolic activity	Measurement of tissue metabolic products (eg pyruvate) from diffusate extracted with microdialysis in the Achilles paratenon.	2 hours
Secondary	collagen production	Measurement of collagen from diffusate obtained with microdialysis in the Achilles paratenon.	2 hours
Secondary	regional microcirculation	Mixed oxygen tissue saturation is continuously measured in the lower leg with infrared spectroscopy	2.5 hours