Venous Disease
Conditions
Brief summary
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.
Interventions
DEVICECustom-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.
DEVICEOff-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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to comprehend and sign an informed consent and complete study questionnaires * Patient is participating in usual work and home activities with no changes anticipated for the duration of the study * The use of compression stocking is prescribed in accordance with the usual practice and management of venous disorders * The patient will confirm they are willing to pay for the compression stockings.
Exclusion criteria
* The patient has a known allergy to any component of the stocking (latex, etc) * The patient has non-venous source of pain in either leg that could, in the opinion of the investigator, confound the results of the study i.e.Neuropathy, Arterial insufficiency, Diabetes * The patient is confined to bed * The patient has uncontrolled Congestive Heart Failure * The patient has acute dermatitis * The patient has weeping dermatosis * Patients with venous ulcers will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale | 6 weeks | 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. |
| Pain as Assessed by Brief Pain Inventory | Baseline | 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. |
| Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate) | 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. |
| Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS) | 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. |
| Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Will be Progressing to Ablation Therapy | 6 months | Progression to ablation therapy will be determined by patient preference for further intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | Off-the-rack Stockings (Sigvaris) | Custom-manufactured Compression Hosiery (Isobar) | Total |
|---|---|---|---|
| Age, Continuous | 69.0 years STANDARD_DEVIATION 4.2 | 58.5 years STANDARD_DEVIATION 12.5 | 63.75 years STANDARD_DEVIATION 8.35 |
| Race/Ethnicity, Customized African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 4 Participants | 6 Participants |
| Region of Enrollment United States | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Female | 4 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
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.
Time frame: 90 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Custom-manufactured Compression Hosiery (Isobar) | 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
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.
Time frame: 30 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off-the-rack Stockings (Sigvaris) | Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS) | 66.7 score on a scale | Standard Deviation 0 |
| Custom-manufactured Compression Hosiery (Isobar) | Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS) | 48.1 score on a scale | Standard Deviation 0 |
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.
Time frame: Baseline
Population: This data was not collected for 2 in the Off-the-rack stockings (Sigvaris) arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off-the-rack Stockings (Sigvaris) | Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS) | 39.2 score on a scale | Standard Deviation 10.5 |
| Custom-manufactured Compression Hosiery (Isobar) | 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 |
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.
Time frame: 6 months
Population: 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.
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.
Time frame: 30 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off-the-rack Stockings (Sigvaris) | Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate) | 48.3 score on a scale | Standard Deviation 0 |
| Custom-manufactured Compression Hosiery (Isobar) | Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate) | 44.0 score on a scale | Standard Deviation 0 |
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.
Time frame: 90 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Custom-manufactured Compression Hosiery (Isobar) | 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
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.
Time frame: 6 months
Population: 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.
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.
Time frame: Baseline
Population: This data was not collected for 2 in the Off-the-rack stockings (Sigvaris) arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off-the-rack Stockings (Sigvaris) | Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate) | 35.8 score on a scale | Standard Deviation 10 |
| Custom-manufactured Compression Hosiery (Isobar) | 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 |
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.
Time frame: Baseline
Population: Data was not collected for this outcome measure.
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.
Time frame: 90 days
Population: Data was not collected for this outcome measure.
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.
Time frame: 6 months
Population: Data was not collected for this outcome measure.
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.
Time frame: 6 weeks
Population: Data was not collected for this outcome measure.
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.
Time frame: 6 weeks
Population: Data was not collected for this outcome measure.
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.
Time frame: 90 days
Population: Data was not collected for this outcome measure.
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.
Time frame: 6 months
Population: Data was not collected for this outcome measure.
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.
Time frame: 6 months
Population: 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.
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.
Time frame: 90 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Custom-manufactured Compression Hosiery (Isobar) | Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS) | 36.3 score on a scale | Standard Deviation 0 |
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.
Time frame: 30 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off-the-rack Stockings (Sigvaris) | Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS) | 29.9 score on a scale | Standard Deviation 0 |
| Custom-manufactured Compression Hosiery (Isobar) | Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS) | 39.9 score on a scale | Standard Deviation 0 |
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.
Time frame: Baseline
Population: This data was not collected for 2 in the Off-the-rack stockings (Sigvaris) arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off-the-rack Stockings (Sigvaris) | Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS) | 32.5 score on a scale | Standard Deviation 9.5 |
| Custom-manufactured Compression Hosiery (Isobar) | Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS) | 36.8 score on a scale | Standard Deviation 3.7 |
Secondary
Number of Patients Who Will be Progressing to Ablation Therapy
Progression to ablation therapy will be determined by patient preference for further intervention.
Time frame: 6 months
Population: Data was not collected for this outcome measure.