Mild to Moderate Edema of Diabetic Legs Clinical Trial
Official title:
Efficacy of a Mild Compression Diabetic Sock Versus A Non- Compression Diabetic Sock in the Control of Lower Extremity Edema in Patients With Diabetes: A Randomized Controlled Trial
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care