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Did not reach the enrollment goal.
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The purpose of this research study is to assess the efficacy of custom-manufactured compression hosiery (also known as compression stockings) compared to similar off-the-rack (OTR) compression stockings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custom-manufactured compression hosiery (Isobar) | Experimental | The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
|
| Off-the-rack stockings (Sigvaris) | Active Comparator | Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom-manufactured compression hosiery (Isobar) | Device | The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale | Five-point satisfaction scale consists of patients rating their overall postoperative pain management experience using a 5-point rating system. The scale ranges from 1 to 5, with 1 being "extremely dissatisfied", 2 "somewhat dissatisfied", 3 "Neutral/Neither satisfied nor dissatisfied", 4 "somewhat satisfied" and 5 "extremely satisfied" with their postoperative pain care. | 6 weeks |
| Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale | Five-point satisfaction scale consists of patients rating their overall postoperative pain management experience using a 5-point rating system. The scale ranges from 1 to 5, with 1 being "extremely dissatisfied", 2 "somewhat dissatisfied", 3 "Neutral/Neither satisfied nor dissatisfied", 4 "somewhat satisfied" and 5 "extremely satisfied" with their postoperative pain care. | 90 days |
| Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale | Five-point satisfaction scale consists of patients rating their overall postoperative pain management experience using a 5-point rating system. The scale ranges from 1 to 5, with 1 being "extremely dissatisfied", 2 "somewhat dissatisfied", 3 "Neutral/Neither satisfied nor dissatisfied", 4 "somewhat satisfied" and 5 "extremely satisfied" with their postoperative pain care. | 6 months |
| Pain as Assessed by Brief Pain Inventory | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the World Health Organization Collaborating Center for Symptom Evaluation in Cancer Care. The score is an average of seven questions about pain interference in life. The score scale is from 0 to 10. 0 being pain does not interfere and 10 being that it completely interferes. 10 would be a worst outcome. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Will be Progressing to Ablation Therapy | Progression to ablation therapy will be determined by patient preference for further intervention. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart A Harlin, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Off-the-rack Stockings (Sigvaris) | Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb. Off-the-rack stockings (Sigvaris): Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2017 |
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| Off-the-rack stockings (Sigvaris) | Device | Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb. |
|
| Pain as Assessed by Brief Pain Inventory | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the World Health Organization Collaborating Center for Symptom Evaluation in Cancer Care. The score is an average of seven questions about pain interference in life. The score scale is from 0 to 10. 0 being pain does not interfere and 10 being that it completely interferes. 10 would be a worst outcome. | 6 weeks |
| Pain as Assessed by Brief Pain Inventory | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the World Health Organization Collaborating Center for Symptom Evaluation in Cancer Care. The score is an average of seven questions about pain interference in life. The score scale is from 0 to 10. 0 being pain does not interfere and 10 being that it completely interferes. 10 would be a worst outcome. | 90 days |
| Pain as Assessed by Brief Pain Inventory | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the World Health Organization Collaborating Center for Symptom Evaluation in Cancer Care. The score is an average of seven questions about pain interference in life. The score scale is from 0 to 10. 0 being pain does not interfere and 10 being that it completely interferes. 10 would be a worst outcome. | 6 months |
| Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | Baseline |
| Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | 30 days |
| Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | 90 days |
| Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | 6 months |
| Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | Baseline |
| Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | 30 days |
| Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | 90 days |
| Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | 6 months |
| Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | Baseline |
| Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | 30 days |
| Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | 90 days |
| Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | 6 months |
| FG001 | Custom-manufactured Compression Hosiery (Isobar) | The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
| 30 Day Follow up |
|
| 90 Day Follow up |
|
| 6 Month Follow up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Off-the-rack Stockings (Sigvaris) | Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb. Off-the-rack stockings (Sigvaris): Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb. |
| BG001 | Custom-manufactured Compression Hosiery (Isobar) | The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale | Five-point satisfaction scale consists of patients rating their overall postoperative pain management experience using a 5-point rating system. The scale ranges from 1 to 5, with 1 being "extremely dissatisfied", 2 "somewhat dissatisfied", 3 "Neutral/Neither satisfied nor dissatisfied", 4 "somewhat satisfied" and 5 "extremely satisfied" with their postoperative pain care. | Data was not collected for this outcome measure. | Posted | 6 weeks |
|
| ||||||||||||||||||||||
| Primary | Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale | Five-point satisfaction scale consists of patients rating their overall postoperative pain management experience using a 5-point rating system. The scale ranges from 1 to 5, with 1 being "extremely dissatisfied", 2 "somewhat dissatisfied", 3 "Neutral/Neither satisfied nor dissatisfied", 4 "somewhat satisfied" and 5 "extremely satisfied" with their postoperative pain care. | Data was not collected for this outcome measure. | Posted | 90 days |
| |||||||||||||||||||||||
| Primary | Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale | Five-point satisfaction scale consists of patients rating their overall postoperative pain management experience using a 5-point rating system. The scale ranges from 1 to 5, with 1 being "extremely dissatisfied", 2 "somewhat dissatisfied", 3 "Neutral/Neither satisfied nor dissatisfied", 4 "somewhat satisfied" and 5 "extremely satisfied" with their postoperative pain care. | Data was not collected for this outcome measure. | Posted | 6 months |
| |||||||||||||||||||||||
| Primary | Pain as Assessed by Brief Pain Inventory | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the World Health Organization Collaborating Center for Symptom Evaluation in Cancer Care. The score is an average of seven questions about pain interference in life. The score scale is from 0 to 10. 0 being pain does not interfere and 10 being that it completely interferes. 10 would be a worst outcome. | Data was not collected for this outcome measure. | Posted | Baseline |
| |||||||||||||||||||||||
| Primary | Pain as Assessed by Brief Pain Inventory | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the World Health Organization Collaborating Center for Symptom Evaluation in Cancer Care. The score is an average of seven questions about pain interference in life. The score scale is from 0 to 10. 0 being pain does not interfere and 10 being that it completely interferes. 10 would be a worst outcome. | Data was not collected for this outcome measure. | Posted | 6 weeks |
| |||||||||||||||||||||||
| Primary | Pain as Assessed by Brief Pain Inventory | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the World Health Organization Collaborating Center for Symptom Evaluation in Cancer Care. The score is an average of seven questions about pain interference in life. The score scale is from 0 to 10. 0 being pain does not interfere and 10 being that it completely interferes. 10 would be a worst outcome. | Data was not collected for this outcome measure. | Posted | 90 days |
| |||||||||||||||||||||||
| Primary | Pain as Assessed by Brief Pain Inventory | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the World Health Organization Collaborating Center for Symptom Evaluation in Cancer Care. The score is an average of seven questions about pain interference in life. The score scale is from 0 to 10. 0 being pain does not interfere and 10 being that it completely interferes. 10 would be a worst outcome. | Data was not collected for this outcome measure. | Posted | 6 months |
| |||||||||||||||||||||||
| Primary | Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | This data was not collected for 2 in the Off-the-rack stockings (Sigvaris) arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
| ||||||||||||||||||||
| Primary | Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | This data was not collected for 3 in the Off-the-rack stockings (Sigvaris) arm and 3 in the Custom-manufactured compression hosiery (Isobar) arm. | Posted | Mean | Standard Deviation | score on a scale | 30 days |
| ||||||||||||||||||||
| Primary | Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | This data was not collected for 4 in the Off-the-rack stockings (Sigvaris) arm and 3 in the Custom-manufactured compression hosiery (Isobar) arm. | Posted | Mean | Standard Deviation | score on a scale | 90 days |
| ||||||||||||||||||||
| Primary | Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | This data was not collected for any in the Off-the-rack stockings (Sigvaris) arm or any in the Custom-manufactured compression hosiery (Isobar) arm. | Posted | 6 months |
| |||||||||||||||||||||||
| Primary | Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | This data was not collected for 2 in the Off-the-rack stockings (Sigvaris) arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
| ||||||||||||||||||||
| Primary | Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | This data was not collected for 3 in the Off-the-rack stockings (Sigvaris) arm and 3 in the Custom-manufactured compression hosiery (Isobar) arm. | Posted | Mean | Standard Deviation | score on a scale | 30 days |
| ||||||||||||||||||||
| Primary | Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | This data was not collected for 4 in the Off-the-rack stockings (Sigvaris) arm and 3 in the Custom-manufactured compression hosiery (Isobar) arm. | Posted | Mean | Standard Deviation | score on a scale | 90 days |
| ||||||||||||||||||||
| Primary | Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | This data was not collected for any in the Off-the-rack stockings (Sigvaris) arm or any in the Custom-manufactured compression hosiery (Isobar) arm. | Posted | 6 months |
| |||||||||||||||||||||||
| Primary | Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | This data was not collected for 2 in the Off-the-rack stockings (Sigvaris) arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
| ||||||||||||||||||||
| Primary | Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | This data was not collected for 3 in the Off-the-rack stockings (Sigvaris) arm and 3 in the Custom-manufactured compression hosiery (Isobar) arm. | Posted | Mean | Standard Deviation | score on a scale | 30 days |
| ||||||||||||||||||||
| Primary | Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | This data was not collected for 4 in the Off-the-rack stockings (Sigvaris) arm and 3 in the Custom-manufactured compression hosiery (Isobar) arm. | Posted | Mean | Standard Deviation | score on a scale | 90 days |
| ||||||||||||||||||||
| Primary | Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS) | The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. | This data was not collected for any in the Off-the-rack stockings (Sigvaris) arm or any in the Custom-manufactured compression hosiery (Isobar) arm. | Posted | 6 months |
| |||||||||||||||||||||||
| Secondary | Number of Patients Who Will be Progressing to Ablation Therapy | Progression to ablation therapy will be determined by patient preference for further intervention. | Data was not collected for this outcome measure. | Posted | 6 months |
|
90 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Off-the-rack Stockings (Sigvaris) | Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb. Off-the-rack stockings (Sigvaris): Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG001 | Custom-manufactured Compression Hosiery (Isobar) | The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. | 0 | 4 | 0 | 4 | 0 | 4 |
Not provided
Not provided
Small sample size, did not reach target enrollment number.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stuart A Harlin, MD | The University of Texas Health Science Center at Houston | 713-486-5131 | Stuart.A.Harlin@uth.tmc.edu |
| Jan 30, 2020 |
| Prot_SAP_000.pdf |
| Male |
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| Hispanic |
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| White |
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The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
|
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The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
|
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The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
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The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
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The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
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The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
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The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
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The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
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The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
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The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
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The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
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The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb. |
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