The University of Texas Health Science Center, Houston
Who can join
18 and older, any sex, with Venous Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)Primary· Baseline
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.
Group
Value
95% CI
Off-the-rack Stockings (Sigvaris)
35.8
± 10.0
Custom-manufactured Compression Hosiery (Isobar)
45.8
± 6.8
Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)Primary· 30 days
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.
Group
Value
95% CI
Off-the-rack Stockings (Sigvaris)
48.3
± 0
Custom-manufactured Compression Hosiery (Isobar)
44.0
± 0
Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)Primary· 90 days
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.
Group
Value
95% CI
Custom-manufactured Compression Hosiery (Isobar)
47.6
± 0
Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)Primary· Baseline
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.
Group
Value
95% CI
Off-the-rack Stockings (Sigvaris)
32.5
± 9.5
Custom-manufactured Compression Hosiery (Isobar)
36.8
± 3.7
Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)Primary· 30 days
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.
Group
Value
95% CI
Off-the-rack Stockings (Sigvaris)
29.9
± 0
Custom-manufactured Compression Hosiery (Isobar)
39.9
± 0
Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)Primary· 90 days
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.
Group
Value
95% CI
Custom-manufactured Compression Hosiery (Isobar)
36.3
± 0
Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)Primary· Baseline
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.
Group
Value
95% CI
Off-the-rack Stockings (Sigvaris)
39.2
± 10.5
Custom-manufactured Compression Hosiery (Isobar)
54.8
± 10.7
Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)Primary· 30 days
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.
Group
Value
95% CI
Off-the-rack Stockings (Sigvaris)
66.7
± 0
Custom-manufactured Compression Hosiery (Isobar)
48.1
± 0
Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)Primary· 90 days
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.
Group
Value
95% CI
Custom-manufactured Compression Hosiery (Isobar)
58.8
± 0
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center, Houston
Last refreshed: 17 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03630185.