Clinical trial NCT03630185: A Comparison of Custom-manufactured vs. Off-the-rack (OTR) Compression Hosiery for Initial Management of Venous Disease
Official title: A Prospective Randomized-controlled Trial of Custom-manufactured vs. Off-the-rack (OTR) Compression Hosiery for Initial Management of Venous Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Venous Disease
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale
timeFrame: 6 weeks
measure: Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale
timeFrame: 90 days
measure: Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale
timeFrame: 6 months
measure: Pain as Assessed by Brief Pain Inventory
timeFrame: Baseline
measure: Pain as Assessed by Brief Pain Inventory
timeFrame: 6 weeks
measure: Pain as Assessed by Brief Pain Inventory
timeFrame: 90 days
measure: Pain as Assessed by Brief Pain Inventory
timeFrame: 6 months
measure: Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)
timeFrame: Baseline
measure: Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)
timeFrame: 30 days
measure: Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)
timeFrame: 90 days
measure: Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)
timeFrame: 6 months
measure: Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)
timeFrame: Baseline
measure: Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)
timeFrame: 30 days
measure: Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)
timeFrame: 90 days
measure: Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)
timeFrame: 6 months
measure: Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)
timeFrame: Baseline
measure: Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)
timeFrame: 30 days
measure: Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)
timeFrame: 90 days
measure: Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)
timeFrame: 6 months
Secondary outcomes:
measure: Number of Patients Who Will be Progressing to Ablation Therapy
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Stuart A Harlin, MD
role: PRINCIPAL_INVESTIGATOR
References: