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

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.

Study Overview

• Status: Completed
• Conditions: Edema
• Intervention / Treatment: Device: mild compression diabetic sock; Device: Standard diabetic sock

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • North Chicago, Illinois, United States, 60064
      • Rosalind Franklin University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild Compression Diabetic Sock; Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.	Device: mild compression diabetic sock; A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks
Other: Standard Diabetic Sock; A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.	Device: Standard diabetic sock; A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Level	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.	baseline and after four weeks of wearing the socks

Collaborators and Investigators

• Sponsor: Rosalind Franklin University of Medicine and Science
• Collaborators: Madigan Army Medical Center
• Investigators: Principal Investigator: Stephanie Wu, DPM, MS, Rosalind Franklin University of Medicine and Science

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: February 3, 2012
• First Submitted That Met QC Criteria: February 7, 2012
• First Posted (Estimate): February 8, 2012

Study Record Updates

• Last Update Posted (Estimate): June 22, 2016
• Last Update Submitted That Met QC Criteria: May 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: diabetes; edema; compression stockings; swollen leg
• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: ORT 112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO