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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK081021 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to examine the effectiveness of a novel patient education strategy, compared to a standard diabetic foot education. The proposed diabetic foot care education uses personal computer-animated plantar pressure data to educate patients on why and how they should care for their feet.
Using block randomization, subjects with diabetes were assigned to either the standard or the enhanced education group. The effectiveness of enhanced education was evaluated as measured by foot care behavior score, patient's interpretation of neuropathy scores, and the incidence of diabetic foot complications over a course of 1-year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enhanced foot care education | Experimental | In addition to the standard diabetic foot self-care instruction, the importance of daily foot self-care was reinforced at baseline by viewing personal barefoot plantar pressure in gait |
|
| Standard Foot Care Education | Active Comparator | Reviewed the standard diabetic foot self-care instructions, including daily foot inspection and proper footwear at all times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced foot care education | Behavioral | In addition to the standard foot care education, personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated once at baseline visit. The demonstration includes diabetic foot education on the topic of diabetic neuropathy and how barefoot walking can lead to skin breakdown and ulcer formation, which can lead to infection and eventual amputation. The education also highlights the high plantar pressures experienced by individuals while barefoot versus in-shoe and how proper footwear is necessary in conjunction with other standard self-foot care measures to prevent injury and complications. |
| Measure | Description | Time Frame |
|---|---|---|
| Foot Care Behavior Score | Daily foot inspection - number (& % of participants) of participants who inspect their feet at least daily | baseline, 1, 3,6,9 and 12 months |
| Patient Interpretation of Neuropathy (PIN) Questionnaire | Participants who demonstrated an accurate interpretation of diabetic peripheral neuropathy (id2). The score range from 1 (correct interpretation) to 5 (misinterpretation) | Baseline, months 1, 3, 6, and 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Foot Complications | Number of participants with foot complications | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinsup Song, DPM, PhD | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gait Study Center; Temple University School of Podiatric Medicine | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Foot Care Education | Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: "Prevent diabetes problems: Keep your diabetes under control" (NIH Publication No. 07-4349) and "Prevent diabetes problems: Keep your feet and skin healthy" (NIH Publication No. 07-4282). In addition, a 1-page diabetic footwear selection criteria is provided. |
| FG001 | Enhanced Foot Care Education | In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Foot Care Education | Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: "Prevent diabetes problems: Keep your diabetes under control" (NIH Publication No. 07-4349) and "Prevent diabetes problems: Keep your feet and skin healthy" (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed. "Keep your diabetes under control" stresses "sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails." "Keep your skin and feet healthy" emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams. |
| 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 | Foot Care Behavior Score | Daily foot inspection - number (& % of participants) of participants who inspect their feet at least daily | Fewer participants at follow up visits due to drop out | Posted | Count of Participants | Participants | baseline, 1, 3,6,9 and 12 months |
|
1 year
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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 | Standard Foot Care Education | Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: "Prevent diabetes problems: Keep your diabetes under control" (NIH Publication No. 07-4349) and "Prevent diabetes problems: Keep your feet and skin healthy" (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed. "Keep your diabetes under control" stresses "sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails." "Keep your skin and feet healthy" emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cellulitis, foot | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diabetic foot ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment | Diabetic foot ulcer, clean and not infected |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jinsup Song | TUSPM | 2157775872 | jsong@temple.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003929 | Diabetic Neuropathies |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| Standard Foot Care Education | Behavioral | At baseline, a trained staff individually reviewed and dispensed the following brochures: "Prevent diabetes problems: Keep your diabetes under control" (NIH Publication No. 07-4349) and "Prevent diabetes problems: Keep your feet and skin healthy" (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed and dispensed. "Keep your diabetes under control" stresses "sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails." "Keep your skin and feet healthy" emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams. |
|
| BG001 | Enhanced Foot Care Education | In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure Personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated at baseline visit. Investigator explained how excessive barefoot pressure can lead to skin breakdown and ulcer formation. The education also highlights the benefit of proper footwear and self-foot care measures to prevent injury and complications. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Enhanced Foot Care Education | In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure Personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated at baseline visit. Investigator explained how excessive barefoot pressure can lead to skin breakdown and ulcer formation. The education also highlights the benefit of proper footwear and self-foot care measures to prevent injury and complications. |
|
|
|
| Primary | Patient Interpretation of Neuropathy (PIN) Questionnaire | Participants who demonstrated an accurate interpretation of diabetic peripheral neuropathy (id2). The score range from 1 (correct interpretation) to 5 (misinterpretation) | Fewer participants in follow up visits due to drop out | Posted | Mean | Standard Deviation | score on a scale | Baseline, months 1, 3, 6, and 12. |
|
|
|
|
| Secondary | Foot Complications | Number of participants with foot complications | Posted | Count of Participants | Participants | 1 year |
|
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 21 |
| 48 |
| EG001 | Enhanced Foot Care Education | In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure Personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated at baseline visit. Investigator explained how excessive barefoot pressure can lead to skin breakdown and ulcer formation. The education also highlights the benefit of proper footwear and self-foot care measures to prevent injury and complications. | 0 | 51 | 0 | 51 | 30 | 51 |
| lower limb amputation | Infections and infestations | Systematic Assessment |
|
|
| Pre-ulcerative lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ingrown | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hospitalization | Cardiac disorders | Systematic Assessment | Nonstudy related |
|
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| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| id2, month 1 |
|
|
| id2, month 3 |
|
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| id2, month 6 |
|
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| id2, month 9 |
|
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| id2, month 12 |
|
|
| subungual hematoma |
|