Preliminary Investigation of a Smart Compression Therapy Prototype

Compression wraps treat venous leg ulcers when applied correctly. Often, clinicians apply the wraps at the wrong compression, or the wrap loosens, stopping clinical benefits. The study aims to show the feasibility of a smart compression prototype to maintain a set compression level in healthy volunteers. Each volunteer will wear the prototype device on one leg and a standard compression wrap on the other. Volunteers will pump their calves, walk, lie down, and stand at zero, one, and four hours. A pressure sensor placed over each calf will record the compression level during the activities. Volunteers will provide subjective feedback on each device concerning comfort and usability. After four hours, researchers will remove the standard wrap. Volunteers will use the prototype device during daily activities for three days. During the three days, the volunteers will complete a daily journal. The journal will capture the user experience and time the volunteer used the device. A final site visit allows researchers to conduct exit interviews and download the history of applied compression. Researchers will use the data to show that the prototype device maintains therapeutic compression and prove the usability of the device.

Inclusion Criteria:Intact, healthy skin at the application site in both legsCalf circumferences to be within 30 - 50 cm between the medial and lateral head of the gastrocnemiusAble to understand the Patient Information LeafletWilling and able to give informed consentAble to wear, don and doff the compression device without external helpWilling and able to follow the requirements of the clinical investigation planPresence of pedal pulses identified by hand-held Doppler (8 MHz)Ankle Brachial Pressure Index between 0.9 and 1.4Exclusion Criteria:History of signs of previous deep or superficial vein thrombosis/pulmonary embolismPeripheral artery disease ( or ABPI < 0.90 or > 1.4), critical limb ischemia, or arterial ulcerationVaricose veins, varicose eczema, or venous ulcerationChronic lower limb swelling, edema, lymphedema, or lipoedemaRecent surgery within the last three months (such as abdominal, gynecological, hip or knee replacement, or lower limb) that may affect the study in the opinion of the investigatorRecent trauma to a lower limb within the last three monthsChronic obesity (defined as BMI index >40 kg/m^2)Diabetes mellitusPregnancyA pulse rate of fewer than 40 beats/minuteA sitting systolic blood pressure of > 180 and < 100 mmHg and/or a sitting diastolic pressure of > 100 mmHgAny significant illness during the previous four (4) weeksParticipation in any clinical study during the eight (8) weeks preceding the screening periodAny evidence of edema or painSkin diseases, including wounds on the feet or lower limbsAny history of heart, liver, kidney, or vascular diseasesHistory of having been prescribed compression stockings for treatment of a medical conditionSerious allergiesDermatitis with oozing or fragile skinPersons currently using NSAID, Diuretics, Vasodilators, and steriodsDrivers and Driving Professionals