EdemaWear to Reduce Edema in Hospitalized Patients With CVI:

March 21, 2023 updated by: Virginia Capasso, Massachusetts General Hospital

EdemaWear to Reduce Edema in Hospitalized Patients With Chronic Venous Insufficiency: A Pilot Study

The purpose of this pilot study is to evaluate the effectiveness of EdemaWear® fuzzy wale longitudinal compression stockings on reducing lower extremity edema in hospitalized adult patients with a history of CVI who are at high risk of consequent venous leg ulcers (VLU) and patient experience with continuously wearing Edema Wear for up to five days

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Hospitalized patients with chronic venous insufficiency (CVI) are at high risk of venous leg ulcers (VLU) due to lower leg edema and skin changes. Since VLU are associated with prolonged morbidity and appreciable financial burden to the patient and society, prevention of VLU by reduction of lower leg edema is paramount. Although the mainstay of VLU prevention is compression, there is a gap in the acute care toolbox to manage the symptom of CVI edema. Currently, ACE bandages are the single most common 'compression wraps' stocked on inpatient units. The disadvantages of ace wraps, which are long-stretch bandages, are two-fold: 1) lower working pressure impeding venous return to the heart, and 2) higher resting pressure that may cause a tourniquet effect and consequent tissue ischemia. A newer moderately-priced mild compression product (15-20 mmHg), EdemaWear® longitudinal elastic compression stockinet, offers an alternative for hospitalized patients. There is limited evidence about the effectiveness of EdemaWear® (that is, modest reduction of lower leg edema) derived from one case series and two comparative evaluations involving only patients in out-patient clinics. This pilot study will expand the evidence related to the effectiveness of EdemaWear® in reducing lower leg edema to include hospitalized patients with CVI. .

The proposed pilot interventional study which involves a single-group repeated measures design with mixed methods has three aims:

  1. evaluate the effectiveness of EdemaWear fuzzy wale elastic compression stockinet in reducing lower extremity edema in hospitalized adult patients with chronic venous insufficiency as measured by the difference in the volume of each lower extremity from Day 1 and Day 5 of data collection or the day of discharge if it occurs in less than five days
  2. determine through interviews the experience of patients continuously wearing EdemaWear compression garment for up to five days or hospital discharge if it occurs in less than five days
  3. qualitatively describe nurses' perceptions of their patients experience with continuously wearing EdemaWear compression garment for up to five days or hospital discharge if it occurs in less than five days

The procedure:

  • Initial data collection related to demographic variables (age, gender, race, ethnic background), primary diagnosis, comorbid conditions (Charlson Comorbidity Index), CEAP classification of chronic venous disease, medication / treatment regimen, degree of lower extremity edema, volume of lower leg peripheral pulses, ankle-brachial indexes
  • Daily data collection related to changes in health status and treatment
  • Daily measurement of the girth of both lower extremities at 10 cm intervals from mid-foot, up the legs, to just below the knees.
  • Daily interviews of patient and nursing staff related to experience of continuously wearing EdemaWear for up to five days or hospital discharge if it occurs in less than five days

Data analysis:

- Descriptive statistics will be performed on demographic and physiological variables, including number / percent for nominal variables and mean (+SD) for continuous variables. Data will be analyzed to decide whether they meet the assumptions of the planned analyses. Repeated measures ANOVA will be used to determine whether there are significant differences in the volume of the lower legs treated with EdemaWear® across the five time periods. The alpha level will be set at p < .05.

Qualitative data from daily interviews of patients and nursing staff will be analyzed by

  • the PI and Co-Is of this study. Content analysis will be used to analyze the data. The unit of analysis will be phrases or sentences contained in responses to questions in the Interview Guides. Content Analysis is a qualitative research method that is used to isolate and interpret themes, issues, and repeated patterns. They refine understanding as new insights about the data emerge. The strategies for analysis outlined by Downe - Wamboldt will be followed.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • history of CVI (Clinical classification 1-5), with > 2+ edema of the lower legs,
  • > 2+ peripheral pulses (popliteal, dorsalis pedis [DP], and posterior tibial [PT]) or audible biphasic / triphasic Doppler signal, if pulses not palpable.

Exclusion Criteria:

  • open venous stasis ulcer(s) or other wounds on lower legs
  • lymphedema or risk factors for lymphedema
  • acute heart failure with active management
  • known deep vein thrombosis (DVT) with subtherapeutic anticoagulation
  • peripheral arterial disease (PAD) with reduced / absent pulses
  • known or suspected inferior vena caval (IVC) compression
  • circumference of lower leg < 45 cm or > 115 cm (size limits of small and extra-large EdemaWear®)
  • severely altered mental status or lacking capacity to consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Edema Wear
Edema Wear fuzzy wale compression garment worn on lower extremities continuously for 5 days or until discharge if less than 5 days.
Device: Edema Wear fuzzy wale compression garment
net-like compression structure of Lycra spandex elastic yarn with longitudinal fuzzy wales (similar to corduroy fabric)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in lower leg volume
Time Frame: up to 5 days
Difference between volume of lower leg / foot between Day 1 and Day 5 (or day of hospital discharge if less than 5 days)
up to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2019

Primary Completion (Actual)

September 15, 2019

Study Completion (Actual)

September 15, 2019

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 5, 2019

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018 JIE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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