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

Rosalind Franklin University of Medicine and Science

Status

Completed

Conditions

Edema

Treatments

Device: mild compression diabetic sock

Device: Standard diabetic sock

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT01529385

ORT 112

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.