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| Name | Class |
|---|---|
| Madigan Army Medical Center | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Compression Diabetic Sock | Experimental | Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. |
|
| Standard Diabetic Sock | Other | A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mild compression diabetic sock | Device | A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Wu, DPM, MS | Rosalind Franklin University of Medicine and Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rosalind Franklin University Health System | North Chicago | Illinois | 60064 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mild Compression Diabetic Sock | Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks |
| FG001 | Standard Diabetic Sock | A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mild Compression Diabetic Sock | Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks |
| BG001 | Standard Diabetic Sock |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | percentage change in dielectric constant | change from baseline after 4 weeks of sock usage |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mild Compression Diabetic Sock | Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| spine infection C2-C5 | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| blister on toe | Injury, poisoning and procedural complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Crews, Clinical Scientist | Center for Lower Extremity Ambulatory Research | 847-578-8437 | ryan.crews@rosalindfranklin.edu |
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| ID | Term |
|---|---|
| D004487 | Edema |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Standard diabetic sock | Device | A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks |
|
| 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 |
A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Primary | Calf Edema | The circumference of calf was measured by a tape measure. | Posted | Mean | 95% Confidence Interval | cm | change from baseline after 4 weeks of sock usage |
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| Primary | Ankle Edema | The circumference of ankle was measured by a tape measure. | Posted | Mean | 95% Confidence Interval | cm | change from baseline after 4 weeks of sock usage |
|
|
|
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| Primary | Toe Brachial Index | ratio of systolic blood pressure of toe relative to systolic blood pressure of arm | Posted | Mean | 95% Confidence Interval | unit-less ratio data | change from baseline after 4 weeks of sock usage |
|
|
|
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| Primary | Ankle Brachial Index | ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm | Posted | Mean | 95% Confidence Interval | unit-less ratio data | change from baseline after 4 weeks of sock usage |
|
|
|
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| Primary | Foot Edema | The circumference of the foot was measured by a tape measure. | Posted | Mean | 95% Confidence Interval | cm | change from baseline after 4 weeks of sock usage |
|
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| Secondary | 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. | physical activity measurements were only made for a sub-sample of the study's complete sample | Posted | Mean | Standard Deviation | steps | baseline and after four weeks of wearing the socks |
|
|
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| Primary | Microcirculation for Medial Calf | microcirculation as measured by skin perfusion pressure | Posted | Mean | 95% Confidence Interval | mmHg | change from baseline after 4 weeks of sock usage |
|
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| Primary | Microcirculation for Lateral Calf | microcirculation as measured by skin perfusion pressure | Posted | Mean | 95% Confidence Interval | mmHg | change from baseline after 4 weeks of sock usage |
|
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| Primary | Microcirculation for Dorsum of Foot | microcirculation as measured by skin perfusion pressure | Posted | Mean | 95% Confidence Interval | mmHg | change from baseline after 4 weeks of sock usage |
|
|
|
|
| 2 |
| 38 |
| 4 |
| 38 |
| EG001 | Standard Diabetic Sock | A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks | 1 | 39 | 6 | 39 |
| excessive fluid retention | Vascular disorders |
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| fluid retention and hypertension | Vascular disorders |
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| fall induced knee pain | Musculoskeletal and connective tissue disorders |
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| lower extremity numbness | Nervous system disorders |
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| cold | General disorders |
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| shingles | Infections and infestations |
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| pruritic lesions | Skin and subcutaneous tissue disorders |
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| cramping in feet | Musculoskeletal and connective tissue disorders |
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| skin irritation | Skin and subcutaneous tissue disorders |
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| cramping in calf | Musculoskeletal and connective tissue disorders |
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| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| change after 3 weeks |
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| change after 4 weeks |
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| change after 3 weeks |
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| change after 4 weeks |
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| change after 4 weeks |
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| change after 4 weeks |
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| change after 3 weeks |
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