Mild Compression Sock for Control of Lower Extremity Edema in Individuals With Diabetes
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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 |
- 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.
- 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: | February 2014 |
| Estimated Primary Completion Date: | February 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 |
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| Contact: Ryan T Crews, MS | 847-578-8437 | ryan.crews@rosalindfranklin.edu |
| Contact: Stephanie Wu, DPM, MS | 847-578-8420 | stephanie.wu@rosalindfranklin.edu |
| 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 | |
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: | September 10, 2012 |
| 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 May 22, 2013