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

Completed · Not applicable

Conditions studied: Edema

In brief

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.

Key facts

Study ID

NCT01529385

Run by

Rosalind Franklin University of Medicine and Science

People needed

80

Starts

2012-02-01

Expected to finish

2014-09-01

Last updated by the study team

2016-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rosalind Franklin University Health System — North Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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