None listed
Conditions
Brief summary
The purpose of the research is to investigate the effects of a sequential calf compressor device, which is somewhat similar to a blood pressure cuff, on lower leg swelling when it is a result of poor vein function. The study also wishes to evaluate if there are any safety concerns with this device. It is hypothesized that there will be improvement on lower leg swelling, as well as being a safe intervention.
Interventions
The calf compressor device resembles a large blood pressure (BP) cuff. It is made of hypoallergenic polyurethane and has a 30cm x10cm battery casing and pump attached to it. The device wraps around the calf and velcros to itself, much like a BP cuff would. Instead of having only a single inflatable chamber, the device has three chambers arranged one above the other. This allows sequential inflation to promote one way venous flow. The chambers inflate to 80mmHg (can be set lower in case of discom
The calf compressor device resembles a large blood pressure (BP) cuff. It is made of hypoallergenic polyurethane and has a 30cm x10cm battery casing and pump attached to it. The device wraps around the calf and velcros to itself, much like a BP cuff would. Instead of having only a single inflatable chamber, the device has three chambers arranged one above the other. This allows sequential inflation to promote one way venous flow. The chambers inflate to 80mmHg (can be set lower in case of discomfort with a range of 40-80mmHg), starting with the most distal chamber, then the middle chamber, then the most proximal chamber. They then deflate from the most proximal to most distal. The cycle repeats after 10 seconds of inactivity. Patients will have the calf compressor placed around their calf and be asked to sit for 20 mins of rest. The device is then turned on and venous peak flow velocity is measured at fours places: external iliac, common femoral, distal superficial femoral and popliteal vein levels. Measurements will be the average of 5 repeated determinations of the peak flow velocity at these points. Patients will then be asked to continue wearing the device for 1 hour while it is turned on to assess tolerance. Its use should be ceased prior to this time in case of any adverse events, which will be recorded. Pre and post use calf measurements taken around the widest point of the calf are to be recorded to assess for any change in swelling. Comparison between baseline and post calf compression measurements will be made. Any adverse events as a result of use of the device will be recorded to help assess safety of the device.
Sponsors
William Alexander
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
History of varicose veins, chronic venous disease symptoms, or chronic leg swelling associated with previous DVT or recent surgery who are unable or unwilling to utilise calf compression stockings (standard of care).
Exclusion criteria
With acute deep venous thrombosis, acute pulmonary emboli, leg ulcerations, or any open wound, history of malignancies requiring active chemotherapy, unable to consent or under the age of 18.
Outcome results
None listed