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

Not Applicable

Completed

Interventions: Device: mild compression diabetic sock
Device: Standard diabetic sock

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Male or female with lower extremity edema aged 18 or older with the ability and willingness to provide Informed consent
Patient's ankle-brachial systolic pressure index > 0.6 and toe-brachial index > 0.3
Patient is willing to participate in all procedures and follow up evaluations necessary to complete the study.
Patient has diabetes type 1 or type 2 confirmed by patient's primary care physician.

Exclusion Criteria

Patients with active wound infection, or untreated osteomyelitis, gangrene
Patients with dementia, or impaired cognitive function that would prohibit study compliance
Patients with wide spread malignancy or systemically immuno-compromising disease
Patients who are unable or unwilling to participate in all procedures and follow up evaluations
Patient with deep and/or large ulcers that require copious bandaging and may affect efficacy of socks. Patients with superficial ulcers that only require a light dressing are not excluded. The ulcer, if present, must be superficial and cannot exhibit any clinical signs of infection
Patients with restless leg syndrome, Parkinson's disease, or other disease that will cause involuntary movement during microvascular assessment
Patients with severe edema or calf circumference greater than 24" or 46cm
Patients with severe lymphedema
Patients with edema that in the opinion of the investigator requires higher compression than the 18-25mmHg provided by the compression socks
Patients who are currently wearing compression hose. (Patients who have been prescribed compression hose but have not worn compression stockings for the past 6 months can be included in the study)
Patients unable to walk one hundred feet.

Arm && Interventions

Group	Intervention	Description
Mild Compression Diabetic Sock	mild compression diabetic sock	Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
Standard Diabetic Sock	Standard diabetic sock	A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.

Primary Outcome Measures

Name	Time	Method
Foot Edema	change from baseline after 4 weeks of sock usage	The circumference of the foot was measured by a tape measure.
Microcirculation for Lateral Calf	change from baseline after 4 weeks of sock usage	microcirculation as measured by skin perfusion pressure
Microcirculation for Dorsum of Foot	change from baseline after 4 weeks of sock usage	microcirculation as measured by skin perfusion pressure
Microcirculation for Medial Calf	change from baseline after 4 weeks of sock usage	microcirculation as measured by skin perfusion pressure
Calf Edema	change from baseline after 4 weeks of sock usage	The circumference of calf was measured by a tape measure.
Cutaneous Water Content	change from baseline after 4 weeks of sock usage	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.
Ankle Edema	change from baseline after 4 weeks of sock usage	The circumference of ankle was measured by a tape measure.
Toe Brachial Index	change from baseline after 4 weeks of sock usage	ratio of systolic blood pressure of toe relative to systolic blood pressure of arm
Ankle Brachial Index	change from baseline after 4 weeks of sock usage	ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm

Secondary Outcome Measures

Name	Time	Method
Physical Activity Level	baseline and after four weeks of wearing the socks	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.