Trial Outcomes & Findings for A Comparison of Custom-manufactured vs. Off-the-rack (OTR) Compression Hosiery for Initial Management of Venous Disease (NCT NCT03630185)
NCT ID: NCT03630185
Last Updated: 2020-02-17
Results Overview
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.
TERMINATED
NA
8 participants
6 weeks
2020-02-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
30 Day Follow up
|
1
|
1
|
|
Overall Study
90 Day Follow up
|
0
|
1
|
|
Overall Study
6 Month Follow up
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Custom-manufactured vs. Off-the-rack (OTR) Compression Hosiery for Initial Management of Venous Disease
Baseline characteristics by cohort
| Measure |
Off-the-rack Stockings (Sigvaris)
n=4 Participants
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.
|
Custom-manufactured Compression Hosiery (Isobar)
n=4 Participants
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.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.0 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
63.75 years
STANDARD_DEVIATION 8.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Data was not collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 90 daysPopulation: Data was not collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data was not collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: BaselinePopulation: Data was not collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 weeksPopulation: Data was not collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 90 daysPopulation: Data was not collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data was not collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: BaselinePopulation: This data was not collected for 2 in the Off-the-rack stockings (Sigvaris) arm.
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.
Outcome measures
| Measure |
Custom-manufactured Compression Hosiery (Isobar)
n=4 Participants
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.
|
Off-the-rack Stockings (Sigvaris)
n=2 Participants
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.
|
|---|---|---|
|
Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)
|
45.8 score on a scale
Standard Deviation 6.8
|
35.8 score on a scale
Standard Deviation 10.0
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 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.
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.
Outcome measures
| Measure |
Custom-manufactured Compression Hosiery (Isobar)
n=1 Participants
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.
|
Off-the-rack Stockings (Sigvaris)
n=1 Participants
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.
|
|---|---|---|
|
Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)
|
44.0 score on a scale
Standard Deviation 0
|
48.3 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 90 daysPopulation: 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.
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.
Outcome measures
| Measure |
Custom-manufactured Compression Hosiery (Isobar)
n=1 Participants
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.
|
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.
|
|---|---|---|
|
Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)
|
47.6 score on a scale
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: BaselinePopulation: This data was not collected for 2 in the Off-the-rack stockings (Sigvaris) arm.
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.
Outcome measures
| Measure |
Custom-manufactured Compression Hosiery (Isobar)
n=4 Participants
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.
|
Off-the-rack Stockings (Sigvaris)
n=2 Participants
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.
|
|---|---|---|
|
Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)
|
36.8 score on a scale
Standard Deviation 3.7
|
32.5 score on a scale
Standard Deviation 9.5
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 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.
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.
Outcome measures
| Measure |
Custom-manufactured Compression Hosiery (Isobar)
n=1 Participants
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.
|
Off-the-rack Stockings (Sigvaris)
n=1 Participants
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.
|
|---|---|---|
|
Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)
|
39.9 score on a scale
Standard Deviation 0
|
29.9 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 90 daysPopulation: 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.
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.
Outcome measures
| Measure |
Custom-manufactured Compression Hosiery (Isobar)
n=1 Participants
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.
|
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.
|
|---|---|---|
|
Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)
|
36.3 score on a scale
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: BaselinePopulation: This data was not collected for 2 in the Off-the-rack stockings (Sigvaris) arm.
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.
Outcome measures
| Measure |
Custom-manufactured Compression Hosiery (Isobar)
n=4 Participants
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.
|
Off-the-rack Stockings (Sigvaris)
n=2 Participants
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.
|
|---|---|---|
|
Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)
|
54.8 score on a scale
Standard Deviation 10.7
|
39.2 score on a scale
Standard Deviation 10.5
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 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.
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.
Outcome measures
| Measure |
Custom-manufactured Compression Hosiery (Isobar)
n=1 Participants
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.
|
Off-the-rack Stockings (Sigvaris)
n=1 Participants
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.
|
|---|---|---|
|
Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)
|
48.1 score on a scale
Standard Deviation 0
|
66.7 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 90 daysPopulation: 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.
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.
Outcome measures
| Measure |
Custom-manufactured Compression Hosiery (Isobar)
n=1 Participants
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.
|
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.
|
|---|---|---|
|
Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)
|
58.8 score on a scale
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data was not collected for this outcome measure.
Progression to ablation therapy will be determined by patient preference for further intervention.
Outcome measures
Outcome data not reported
Adverse Events
Off-the-rack Stockings (Sigvaris)
Custom-manufactured Compression Hosiery (Isobar)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Stuart A Harlin, MD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place