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

Not Applicable

Terminated

• Conditions: Venous Disease

• Registration Number: NCT03630185
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-25
• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-14
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2020-02
• Results First Submitted: 2020-02-03
• Results First Submitted QC: 2020-02-03
• Last Update Submitted: 2020-02-03
• Results First Posted: 2020-02-17
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)	6 months	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.
Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale	6 months	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	6 months	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)	6 months	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)	6 months	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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States