A Comparison of Custom-manufactured vs. Off-the-rack (OTR) Compression Hosiery for Initial Management of Venous Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized-controlled Trial of Custom-manufactured vs. Off-the-rack (OTR) Compression Hosiery for Initial Management of Venous Disease

Conditions
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Venous Disease

Intervention / Treatment
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* Device: Custom-manufactured compression hosiery (Isobar)
* Device: Off-the-rack stockings (Sigvaris)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Custom-manufactured compression hosiery (Isobar)<br>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. | Device: Custom-manufactured compression hosiery (Isobar)<br>* 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.<br>|
| Active Comparator: Off-the-rack stockings (Sigvaris)<br>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. | Device: Off-the-rack stockings (Sigvaris)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |