The purpose of this study is to determine whether a specially designed sock for people with diabetes and swelling in the legs can reduce the swelling, improve blood flow to the legs, and improve physical activity patterns of those individuals by providing mild compression to their legs.
Peripheral arterial disease (PAD) is commonly associated with diabetes. Clinicians are often reluctant to apply compressive stockings to patients with diabetes and swollen legs due to fear of exacerbating the symptoms of PAD. The study sock is a newly formulated sock that offers mild compression (18-25mmHg). The sock is made especially for the diabetic patient who suffers from concomitant lower extremity edema. Eighty patients with diabetes and lower extremity edema will be recruited. Upon ensuring enrollment criteria are met, baseline edema (as measured by circumference of foot, ankle and calf), ankle brachial index (ABI), skin perfusion pressure, and cutaneous fluid level (as measured by MoistureMeter) will be assessed. Subjects will then be provided four pairs of socks. Subjects will be randomized in a 1:1 distribution to receive either the mild compression diabetic socks or a standard diabetic sock. They will return for four weekly follow up visits. Additionally a sub-set of 30 subjects will be monitored for changes in physical activity pre and post sock usage. Physical activity monitors will be used to assess daily physical activity for 48hrs prior to receiving the socks and after wearing the socks for four weeks an additional 48hrs will be monitored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
80
A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks
A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Rosalind Franklin University Health System
North Chicago, Illinois, United States
Cutaneous Water Content
Cutaneous water content was measured non-invasively by tissue dielectric constant (MoistureMeter) at a single location: 2 inches distal and 2 inches lateral to the fibular head.
Time frame: change from baseline after 4 weeks of sock usage
Calf Edema
The circumference of calf was measured by a tape measure.
Time frame: change from baseline after 4 weeks of sock usage
Ankle Edema
The circumference of ankle was measured by a tape measure.
Time frame: change from baseline after 4 weeks of sock usage
Toe Brachial Index
ratio of systolic blood pressure of toe relative to systolic blood pressure of arm
Time frame: change from baseline after 4 weeks of sock usage
Ankle Brachial Index
ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm
Time frame: change from baseline after 4 weeks of sock usage
Foot Edema
The circumference of the foot was measured by a tape measure.
Time frame: change from baseline after 4 weeks of sock usage
Microcirculation for Medial Calf
microcirculation as measured by skin perfusion pressure
Time frame: change from baseline after 4 weeks of sock usage
Microcirculation for Lateral Calf
microcirculation as measured by skin perfusion pressure
Time frame: change from baseline after 4 weeks of sock usage
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Microcirculation for Dorsum of Foot
microcirculation as measured by skin perfusion pressure
Time frame: change from baseline after 4 weeks of sock usage
Physical Activity Level
Physical activity monitors will be used to assess physical activity patters of participants for 48 hours prior to initiating sock usage and for 48 hours after the participants have worn the socks for four weeks.
Time frame: baseline and after four weeks of wearing the socks