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

NCT03630185 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-02-17

Study results available
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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.

Conditions

  • Venous Disease

Interventions

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.

DEVICE

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Stuart A Harlin, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-25
Primary Completion
2018-11-30
Completion
2018-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03630185 on ClinicalTrials.gov