NCT03630185

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-04-25
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2018-08-14
• Last updated: 2020-02-17
• Results posted: 2020-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study