NCT03904602

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

August 19, 2019

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

27 days

First QC Date

April 3, 2019

Last Update Submit

March 21, 2023

Conditions

Chronic Venous Insufficiency

Keywords

Chronic Venous InsufficiencyCVI

Outcome Measures

Primary Outcomes (1)

  • 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)

    up to 5 days

Study Arms (1)

Edema Wear

EXPERIMENTAL

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

Interventions

Edema Wear fuzzy wale compression garmentDEVICE

net-like compression structure of Lycra spandex elastic yarn with longitudinal fuzzy wales (similar to corduroy fabric)

Edema Wear

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (13)

  • 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.

    PMID: 26358303BACKGROUND

  • 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.

    PMID: 24974070BACKGROUND

  • Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2014 Jul 22;130(4):333-46. doi: 10.1161/CIRCULATIONAHA.113.006898. No abstract available.

    PMID: 25047584BACKGROUND

  • 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.

    PMID: 3558716BACKGROUND

  • 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.

    PMID: 16000093BACKGROUND

  • 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.

    PMID: 19251582BACKGROUND

  • 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.

    PMID: 29719182BACKGROUND

  • 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.

    PMID: 25435653BACKGROUND

  • 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.

    PMID: 23159553BACKGROUND

  • 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.

    PMID: 27689831BACKGROUND

  • Casley-Smith JR. Measuring and representing peripheral oedema and its alterations. Lymphology. 1994 Jun;27(2):56-70.

    PMID: 8078362BACKGROUND

  • 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.

    PMID: 9476247BACKGROUND

  • Downe-Wamboldt B. Content analysis: method, applications, and issues. Health Care Women Int. 1992 Jul-Sep;13(3):313-21. doi: 10.1080/07399339209516006.

    PMID: 1399871BACKGROUND

Related Links

Study Officials

  • Virginia Capasso, PhD, APRN

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse Specialist

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 5, 2019

Study Start

August 19, 2019

Primary Completion

September 15, 2019

Study Completion

September 15, 2019

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)