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

This study is currently recruiting participants.
Verified December 2013 by Rosalind Franklin University of Medicine and Science
Sponsor:
Collaborator:
Madigan Army Medical Center
Information provided by (Responsible Party):
Dr. Stephanie Wu, DPM, MS, Rosalind Franklin University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT01529385
First received: February 3, 2012
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Mild to Moderate Edema of Diabetic Legs
Device: mild compression diabetic sock
Device: Standard diabetic sock

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Rosalind Franklin University of Medicine and Science:

Primary Outcome Measures:
  • lower extremity edema [ Time Frame: change from baseline after 1, 2, 3, and 4 weeks of sock usage ] [ Designated as safety issue: No ]
    The circumference of the foot, ankle and calf will be measured by a tape measurer. Cutaneous fluid will be measured non-invasively by a MoistureMeter.

  • lower extremity vascular status [ Time Frame: change from baseline after 1,2,3, and 4 weeks of sock usage ] [ Designated as safety issue: Yes ]
    The ankle-brachial index, toe-brachial index, skin perfusion pressure and pulse volume recordings will be measured.


Secondary Outcome Measures:
  • physical activity level [ Time Frame: baseline and after four weeks of wearing the socks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529385

Contacts
Contact: Ryan T Crews, MS 847-578-8437 ryan.crews@rosalindfranklin.edu
Contact: Stephanie Wu, DPM, MS 847-578-8420 stephanie.wu@rosalindfranklin.edu

Locations
United States, Illinois
Rosalind Franklin University Health System Recruiting
North Chicago, Illinois, United States, 60064
Contact: Ryan Crews, MS    847-578-8437    ryan.crews@rosalindfranklin.edu   
Principal Investigator: Stephanie Wu, DPM, MS         
Sponsors and Collaborators
Rosalind Franklin University of Medicine and Science
Madigan Army Medical Center
  More Information

No publications provided

Responsible Party: Dr. Stephanie Wu, DPM, MS, Director of Center for Lower Extremity Ambulatory Research, Rosalind Franklin University of Medicine and Science
ClinicalTrials.gov Identifier: NCT01529385     History of Changes
Other Study ID Numbers: ORT 112
Study First Received: February 3, 2012
Last Updated: December 3, 2013
Health Authority: United States: Rosalind Franklin University Institutional Review Board

Keywords provided by Rosalind Franklin University of Medicine and Science:
swollen leg
diabetes
compression stockings
edema

Additional relevant MeSH terms:
Edema
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014