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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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We will identify a cohort of high-risk diabetic patients and assign them to two treatment groups. We plan to enroll patients from three sites: Scott and White Hospital in Temple Texas, Manchester Royal Infirmary, UK , and Trinity College Dublin at St James Hospital.. The two treatment arms will involve a Standard Therapy Group, and a Stocking Therapy Group. The Stocking Therapy group will use the special padded and friction reducing stockings in their standard shoes during the course of the study. Patient enrollment will occur over a one-year period. All patients will be followed for 30 months. The Standard Therapy Group will receive therapeutic shoes, standard insoles, patient education and regular foot evaluations by a physician every 10-12 weeks. The Stocking Therapy Group will receive standard therapy as described above but use the special stockings instead of their usual hose. The investigator at each site will be blinded regarding the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard therapy | Active Comparator | Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. |
|
| PFC Stockings | Active Comparator | The stocking therapy group will be given PFC shear reducing stockings to wear. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard therapy | Behavioral | Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Developed Foot Ulcer During Study Time Frame | An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures. | 30 months |
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Inclusion Criteria:
Spanish-speaking subjects will be eligible to participate.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Lavery, DPM | UT Southwestern Medical Center at Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Health & Hospital Systems | Dallas | Texas | 75235 | United States | ||
| UT Southwestern Medical Center at Dallas |
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| ID | Title | Description |
|---|---|---|
| FG000 | PFC Stockings | The stocking therapy group will be given PFC shear reducing stockings to wear. PFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases. |
| FG001 | Standard Therapy | Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PFC Stockings | The stocking therapy group will be given PFC shear reducing stockings to wear. PFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases. |
| 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 | Number of Participants Who Developed Foot Ulcer During Study Time Frame | An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures. | Posted | Count of Participants | Participants | 30 months |
|
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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 | PFC Stockings | The stocking therapy group will be given PFC shear reducing stockings to wear. PFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot related readmission | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Lavery, DPM, MPH | UT Southwestern Medical Center at Dallas | 214-645-0544 | Larry.Lavery@UTSouthwestern.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| PFC Stockings | Device | A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases. |
|
| Dallas |
| Texas |
| 75390 |
| United States |
| Scott & White | Temple | Texas | 76502 | United States |
| University of Manchester | Manchester | United Kingdom |
| BG001 | Standard Therapy | Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
|
|
| 7 |
| 195 |
| 30 |
| 195 |
| 99 |
| 195 |
| EG001 | Standard Therapy | Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. | 7 | 186 | 16 | 186 | 99 | 186 |
| Non-foot related hospitalization | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Amputation | Surgical and medical procedures | Systematic Assessment |
|
| New foot ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Mechanical fall | Nervous system disorders | Systematic Assessment |
|
| Foot fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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