Clinical trial NCT01529385: Mild Compression Sock for Control of Lower Extremity Edema in Individuals With Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edema
Keywords: swollen leg
diabetes
compression stockings
edema
Lead sponsor: Rosalind Franklin University of Medicine and Science
Sponsor class: OTHER
Collaborators: name: Madigan Army Medical Center
First posted: 2012-02-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cutaneous Water Content
timeFrame: change from baseline after 4 weeks of sock usage
measure: Calf Edema
timeFrame: change from baseline after 4 weeks of sock usage
measure: Ankle Edema
timeFrame: change from baseline after 4 weeks of sock usage
measure: Toe Brachial Index
timeFrame: change from baseline after 4 weeks of sock usage
measure: Ankle Brachial Index
timeFrame: change from baseline after 4 weeks of sock usage
measure: Foot Edema
timeFrame: change from baseline after 4 weeks of sock usage
measure: Microcirculation for Medial Calf
timeFrame: change from baseline after 4 weeks of sock usage
measure: Microcirculation for Lateral Calf
timeFrame: change from baseline after 4 weeks of sock usage
measure: Microcirculation for Dorsum of Foot
timeFrame: change from baseline after 4 weeks of sock usage
Secondary outcomes:
measure: Physical Activity Level
timeFrame: baseline and after four weeks of wearing the socks
Other outcomes:
Locations:
city: North Chicago
country: United States
facility: Rosalind Franklin University Health System
state: Illinois
Study officials:
affiliation: Rosalind Franklin University of Medicine and Science
name: Stephanie Wu, DPM, MS
role: PRINCIPAL_INVESTIGATOR
References: