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

NCT ID: NCT01529385

Last Updated: 2016-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-09-30

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.

Conditions

Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Mild Compression Diabetic Sock

Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.

Group Type: EXPERIMENTAL

mild compression diabetic sock

Intervention Type: DEVICE

A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks

Standard Diabetic Sock

A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.

Group Type: OTHER

Standard diabetic sock

Intervention Type: DEVICE

A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks

Interventions

mild compression diabetic sock

A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks

Intervention Type: DEVICE

Standard diabetic sock

A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Madigan Army Medical Center

FED

Sponsor Role: collaborator

Rosalind Franklin University of Medicine and Science

OTHER

Sponsor Role: lead

Responsible Party

Dr. Stephanie Wu, DPM, MS

Director of Center for Lower Extremity Ambulatory Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Wu, DPM, MS

Role: PRINCIPAL_INVESTIGATOR

Rosalind Franklin University of Medicine and Science

Locations

Rosalind Franklin University Health System

North Chicago, Illinois, United States

Countries

United States

Other Identifiers

ORT 112

Identifier Type: -

Identifier Source: org_study_id