NCT01529385

Mild Compression Sock for Control of Lower Extremity Edema in Individuals With Diabetes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Rosalind Franklin University of Medicine and Science · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Edema

Interventions

Type	Name	Description
DEVICE	mild compression diabetic sock	A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks
DEVICE	Standard diabetic sock	A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-02-08
• Last updated: 2016-06-22
• Results posted: 2016-06-22

Locations

1 site across 1 country: United States