Preliminary Investigation of a Smart Compression Therapy Prototype (PRESUF-VLU)

Inclusion Criteria: Intact, healthy skin at the application site in both legs Calf circumferences to be within 30 - 50 cm between the medial and lateral head of the gastrocnemius Able to understand the Patient Information Leaflet Willing and able to give informed consent Able to wear, don and doff the compression device without external help Willing and able to follow the requirements of the clinical investigation plan Presence of pedal pulses identified by hand-held Doppler (8 MHz) Ankle Brachial Pressure Index between 0.9 and 1.4 Exclusion Criteria: History of signs of previous deep or superficial vein thrombosis/pulmonary embolism Peripheral artery disease ( or ABPI < 0.90 or > 1.4), critical limb ischemia, or arterial ulceration Varicose veins, varicose eczema, or venous ulceration Chronic lower limb swelling, edema, lymphedema, or lipoedema Recent 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 investigator Recent trauma to a lower limb within the last three months Chronic obesity (defined as BMI index >40 kg/m^2) Diabetes mellitus Pregnancy A pulse rate of fewer than 40 beats/minute A sitting systolic blood pressure of > 180 and < 100 mmHg and/or a sitting diastolic pressure of > 100 mmHg Any significant illness during the previous four (4) weeks Participation in any clinical study during the eight (8) weeks preceding the screening period Any evidence of edema or pain Skin diseases, including wounds on the feet or lower limbs Any history of heart, liver, kidney, or vascular diseases History of having been prescribed compression stockings for treatment of a medical condition Serious allergies Dermatitis with oozing or fragile skin Persons currently using NSAID, Diuretics, Vasodilators, and steriods Drivers and Driving Professionals