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

Venous Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03630185
• Other study ID #: HSC-MS-17-0015
• Status: Terminated
• Phase: N/A
• Start date: April 25, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: February 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Venous Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	6 months