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

NCT01529385 | Completed Results

• 1 other identifier: ORT 112
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Edema

Keywords

swollen leg; diabetes; compression stockings; edema

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Physical Activity Level

  baseline and after four weeks of wearing the socks

Study Arms (2)

Mild Compression Diabetic Sock

EXPERIMENTAL

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

Device: mild compression diabetic sock

Standard Diabetic Sock

OTHER

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

Device: Standard diabetic sock

Interventions

mild compression diabetic sock DEVICE

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

Mild Compression Diabetic Sock

Standard diabetic sock DEVICE

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

Standard Diabetic Sock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Rosalind Franklin University of Medicine and Science: lead
• Madigan Army Medical Center: collaborator

Study Sites (1)

Rosalind Franklin University Health System

North Chicago, Illinois, 60064, United States

Location

MeSH Terms

Conditions

Edema; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Ryan Crews, Clinical Scientist
• Organization: Center for Lower Extremity Ambulatory Research

ryan.crews@rosalindfranklin.edu

847-578-8437

Study Officials

• Stephanie Wu, DPM, MS

  Rosalind Franklin University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Center for Lower Extremity Ambulatory Research

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 8, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 22, 2016
• Results First Posted: June 22, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)