An interventional study of Edema Wear fuzzy wale compression garment in Chronic Venous Insufficiency, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
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
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:
The procedure:
Data analysis:
Qualitative data from daily interviews of patients and nursing staff will be analyzed by
189 studies on the registry are indexed under Venous Insufficiency; 16 are open to participants now.
This study's enrollment of 3 is below the median of 60 across 139 interventional studies indexed under Venous Insufficiency.
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Exclusion Criteria:
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)
change in lower leg volume
Difference between volume of lower leg / foot between Day 1 and Day 5 (or day of hospital discharge if less than 5 days)
Time frame: up to 5 days
Plan to share: No
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital