Effects of External Leg Compression Devices on Healing and Blood Clotting

NCT03050671 | Enrolling By Invitation

• 1 other identifier: SW2017-01-COAGMET
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Stasis; Deep Venous Thrombosis; Healing Wound

Outcome Measures

Primary Outcomes (1)

• systemic coagulation status

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

  2 hours

Secondary Outcomes (3)

• local metabolic activity

  2 hours

• collagen production

  2 hours

• regional microcirculation

  2.5 hours

Study Arms (2)

Rapid calf-IPC

ACTIVE COMPARATOR

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

Device: Intermittent Pneumatic Compression, Rapid

subjects under slow calf-IPC

ACTIVE COMPARATOR

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

Device: Intermittent Pneumatic Compression, Slow

Interventions

Intermittent Pneumatic Compression, Rapid DEVICE

Cyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a sharp and rapid way

Rapid calf-IPC

Intermittent Pneumatic Compression, Slow DEVICE

Cyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a smooth, slow and progressive way

subjects under slow calf-IPC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Only men are being enrolled in order to avoid possible cyclical hormonal influences on blood flow
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals
• Male gender
• Age 18-60

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska university Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Varicose Ulcer; Venous Thrombosis

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Thrombosis; Embolism and Thrombosis

Study Officials

• Paul Ackermann

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paul Ackermann M.D, Ph.D., Professor Specialist in Orthopaedic Surgery Orthopaedic Department, Karolinska University Hospital

Model Details: There are two different intervension devices planned to be used in each research subject.

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 13, 2017
• Study Start: January 18, 2017
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

SE (1)