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| Name | Class |
|---|---|
| Wake Forest University Health Sciences | OTHER |
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This is a study investigating treatment of plantar fasciitis (heel pain). Physicians commonly prescribe specialized orthoses (shoe inserts) to treat heel pain. This study will evaluate the reduction in heel pain associated with three types of orthoses. It is hypothesized that custom made orthoses will significantly decrease pain and improve foot function in comparison to prefabricated insoles and sham insoles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| custom foot orthoses | Active Comparator | Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study. |
|
| pre-fabricated orthoses | Active Comparator | Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes. |
|
| sham insoles | Sham Comparator | Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orthoses | Device | orthoses are provided for use in standardized shoes that all subjects receive |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heel Pain | Overall foot pain as determined by the Foot Function Index-Revised (FFI-R) survey. Foot pain is assessed by answering 11 questions regarding foot pain experienced over the past week. Scores may range from 11 to 66. Higher scores are indicative of greater foot pain. | baseline, one month and three months |
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Inclusion Criteria:
Patients will be included if they present for each of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Fleischer, DPM, MPH | Center for Lower Extremity Ambulatory Research (CLEAR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Health Care | Chicago | Illinois | 60618 | United States | ||
| Scholl Foot and Ankle Center |
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| Label | URL |
|---|---|
| Center for Lower Extremity Ambulatory Research | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Custom Foot Orthoses | Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study. orthoses: orthoses are provided for use in standardized shoes that all subjects receive |
| FG001 | Pre-fabricated Orthoses | Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes. orthoses: orthoses are provided for use in standardized shoes that all subjects receive |
| FG002 | Sham Insoles | Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study. orthoses: orthoses are provided for use in standardized shoes that all subjects receive |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Custom Foot Orthoses | Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study. orthoses: orthoses are provided for use in standardized shoes that all subjects receive |
| BG001 |
| 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 | Heel Pain | Overall foot pain as determined by the Foot Function Index-Revised (FFI-R) survey. Foot pain is assessed by answering 11 questions regarding foot pain experienced over the past week. Scores may range from 11 to 66. Higher scores are indicative of greater foot pain. | Posted | Mean | Standard Deviation | score on a survey | baseline, one month and three 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 | Custom Foot Orthoses | Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study. orthoses: orthoses are provided for use in standardized shoes that all subjects receive |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Crews | Rosalind Franklin University of Medicine and Science | 847-578-8437 | ryan.crews@rosalindfranklin.edu |
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D061826 | Foot Orthoses |
| ID | Term |
|---|---|
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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|
| North Chicago |
| Illinois |
| 60064 |
| United States |
| Adverse Event |
|
| Pre-fabricated Orthoses |
Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes. orthoses: orthoses are provided for use in standardized shoes that all subjects receive |
| BG002 | Sham Insoles | Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study. orthoses: orthoses are provided for use in standardized shoes that all subjects receive |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| weight | Mean | Standard Deviation | pounds |
|
| height | Mean | Standard Deviation | inches |
|
| duration of plantar fasciitis | Mean | Standard Deviation | months |
|
Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive
| OG002 | Sham Insoles | Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study. orthoses: orthoses are provided for use in standardized shoes that all subjects receive |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Pre-fabricated Orthoses | Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes. orthoses: orthoses are provided for use in standardized shoes that all subjects receive | 0 | 25 | 0 | 25 |
| EG002 | Sham Insoles | Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study. orthoses: orthoses are provided for use in standardized shoes that all subjects receive | 0 | 26 | 0 | 26 |
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