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

Not Applicable

Terminated

Conditions: Venous Disease

Interventions: Device: Off-the-rack stockings (Sigvaris)
Device: Custom-manufactured compression hosiery (Isobar)

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

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

Arm && Interventions

Group	Intervention	Description
Off-the-rack stockings (Sigvaris)	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.
Custom-manufactured compression hosiery (Isobar)	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.

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.