Symptoms Associated With Chronic Venous Disease in Response to a Cooling Treatment Compared to Placebo: A Randomized Clinical Trial.

ABSTRACT:

Purpose

The purpose of this study was to examine the efficacy of a self-administered cooling treatment on clinically meaningful differences (CMDs) in symptom changes in patients with chronic venous disease.

Design

Blinded, prospective, randomized controlled trial.

Subjects and setting

Two hundred seventy-six community-dwelling adults 21 years and older with skin changes and/or a healed venous leg ulcer (Clinical-Etiologic-Anatomic-Pathologic [CEAP] 4 and 5 classification) completed the 6-month active treatment period.

Methods

Participants were recruited from wound and medicine clinics and from the general population through referrals or advertisements. Participants were randomly allocated to a sham control cuff or interventional cooling cuff group. Demographic

SUBMITTER: Kelechi TJ 

PROVIDER: S-EPMC6041185 | biostudies-literature | 2018 Jul/Aug

REPOSITORIES: biostudies-literature