EdemaWear to Reduce Edema in Hospitalized Patients With CVI:
NCT ID: NCT03904602
Last Updated: 2023-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2019-08-19
2019-09-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Edema Wear
Edema Wear fuzzy wale compression garment worn on lower extremities continuously for 5 days or until discharge if less than 5 days.
Edema Wear fuzzy wale compression garment
net-like compression structure of Lycra spandex elastic yarn with longitudinal fuzzy wales (similar to corduroy fabric)
Interventions
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Edema Wear fuzzy wale compression garment
net-like compression structure of Lycra spandex elastic yarn with longitudinal fuzzy wales (similar to corduroy fabric)
Eligibility Criteria
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Inclusion Criteria
* \> 2+ peripheral pulses (popliteal, dorsalis pedis \[DP\], and posterior tibial \[PT\]) or audible biphasic / triphasic Doppler signal, if pulses not palpable.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Virginia Capasso
Clinical Nurse Specialist
Principal Investigators
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Virginia Capasso, PhD, APRN
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Lal BK. Venous ulcers of the lower extremity: Definition, epidemiology, and economic and social burdens. Semin Vasc Surg. 2015 Mar;28(1):3-5. doi: 10.1053/j.semvascsurg.2015.05.002. Epub 2015 May 8.
O'Donnell TF Jr, Passman MA, Marston WA, Ennis WJ, Dalsing M, Kistner RL, Lurie F, Henke PK, Gloviczki ML, Eklof BG, Stoughton J, Raju S, Shortell CK, Raffetto JD, Partsch H, Pounds LC, Cummings ME, Gillespie DL, McLafferty RB, Murad MH, Wakefield TW, Gloviczki P; Society for Vascular Surgery; American Venous Forum. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery (R) and the American Venous Forum. J Vasc Surg. 2014 Aug;60(2 Suppl):3S-59S. doi: 10.1016/j.jvs.2014.04.049. Epub 2014 Jun 25. No abstract available.
Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2014 Jul 22;130(4):333-46. doi: 10.1161/CIRCULATIONAHA.113.006898. No abstract available.
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
Brodovicz KG, McNaughton K, Uemura N, Meininger G, Girman CJ, Yale SH. Reliability and feasibility of methods to quantitatively assess peripheral edema. Clin Med Res. 2009 Jun;7(1-2):21-31. doi: 10.3121/cmr.2009.819. Epub 2009 Feb 26.
Gogalniceanu P, Lancaster RT, Patel VI. Clinical Assessment of Peripheral Arterial Disease of the Lower Limbs. N Engl J Med. 2018 May 3;378(18):e24. doi: 10.1056/NEJMvcm1406358. No abstract available.
Bailey MA, Griffin KJ, Scott DJ. Clinical assessment of patients with peripheral arterial disease. Semin Intervent Radiol. 2014 Dec;31(4):292-9. doi: 10.1055/s-0034-1393964.
Aboyans V, Criqui MH, Abraham P, Allison MA, Creager MA, Diehm C, Fowkes FG, Hiatt WR, Jonsson B, Lacroix P, Marin B, McDermott MM, Norgren L, Pande RL, Preux PM, Stoffers HE, Treat-Jacobson D; American Heart Association Council on Peripheral Vascular Disease; Council on Epidemiology and Prevention; Council on Clinical Cardiology; Council on Cardiovascular Nursing; Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia. Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association. Circulation. 2012 Dec 11;126(24):2890-909. doi: 10.1161/CIR.0b013e318276fbcb. Epub 2012 Nov 16. No abstract available.
Sibley RC 3rd, Reis SP, MacFarlane JJ, Reddick MA, Kalva SP, Sutphin PD. Noninvasive Physiologic Vascular Studies: A Guide to Diagnosing Peripheral Arterial Disease. Radiographics. 2017 Jan-Feb;37(1):346-357. doi: 10.1148/rg.2017160044. Epub 2016 Sep 30.
Casley-Smith JR. Measuring and representing peripheral oedema and its alterations. Lymphology. 1994 Jun;27(2):56-70.
Latchford S, Casley-Smith JR. Estimating limb volumes and alterations in peripheral edema from circumferences measured at different intervals. Lymphology. 1997 Dec;30(4):161-4. No abstract available.
Downe-Wamboldt B. Content analysis: method, applications, and issues. Health Care Women Int. 1992 Jul-Sep;13(3):313-21. doi: 10.1080/07399339209516006.
Related Links
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Bjork R. The long and short of it: Understanding compression bandaging. Wound Care Advisor. 2013; 2(6).
EdemaWear® New Compression Textile.
numeric-pain-rating-scale
Other Identifiers
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2018 JIE
Identifier Type: -
Identifier Source: org_study_id
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