The effect of lower limb fibreglass cast on the efficacy of the Impulse Intermittent Pneumatic Compression (IPC) device on lower limb venous haemodynamics in healthy subjects

Not Applicable

Completed

• Conditions: Venous thromboembolism; Blood - Clotting disorders; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12614000730606
• Lead Sponsor: Medical Research Institiute of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Aged between 18 to 65 years
- Able to provide informed consent

Exclusion Criteria

1. History of previous or current deep vein thrombosis
2. Pregnancy (this may alter lower limb venous return from compression at the level of the iliac vein)
3. Any hyper-coagulable disorders including history of cancer other than basal cell carcinoma of the skin, non-invasive basal cell carcinoma of the skin
4. History or clinical features of peripheral vascular disease (including arterial and venous insufficiency), or other lower limb abnormalities, such as peripheral neuropathy, scleroderma, lymphoedema, or joint deformity from inflammatory arthritis
5. Abnormal clinical examination of the lower limbs, which may indicate one of the above mentioned exclusion medical conditions. (i.e. such as the presence of ischemic ulceration)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In the seated position: the peak systolic velocity (cm/s) in the popliteal vein of the casted limb compared to the non-casted limb at 60 minutes as assessed by ultrasonography (USS).[60 minutes after the IPC device has been running for 10 minutes continuously]

Secondary Outcome Measures

Name	Time	Method
Peak systolic velocity, in the popliteal vein of casted versus non-casted limb as assessed by Ultrasound Sonography (USS). <br><br>[- 40 minutes, immediately prior to starting the IPC device, 50 minutes, after the IPC device has been running for 10 minutes continuously];Mean flow velocity (cm/s), in the popliteal vein of casted versus non-casted limb, as assessed by Ultrasound Sonography (USS). <br>[- 40 minutes, immediately prior to starting the IPC device, 50 minutes, after the IPC device has been running for 10 minutes continuously];Vein diameter (mm) in the popliteal vein of casted versus non-casted limb as assessed by Ultrasound Sonography (USS). <br><br><br>[- 40 minutes, immediately prior to starting the IPC device, 50 minutes, after the IPC device has been running for 10 minutes continuously]