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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Edema

Intervention / Treatment
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* Device: mild compression diabetic sock
* Device: Standard diabetic sock


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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swollen leg, diabetes, compression stockings, edema