Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema

Not Applicable

Terminated

• Conditions: Lymphedema
• Interventions: Device: Flexitouch pneumonic compression; Other: Flexitouch for 1 month in addition to routine wound care; Other: Routine wound care for venous ulcers and lymphedema

• Registration Number: NCT02284373
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this study is to evaluate the effect of pneumatic compression in improving symptoms, quality of life and wound healing in patients with venous ulcers and/or lymphedema.

Detailed Description

This investigation is a randomized clinical trial of a prospective cohort of an estimated 140 subjects with venous ulcers, with an observational cohort of 50 subjects with lymphedema. Venous ulcer subjects will be randomized into two arms:

Randomization Arm 1: 70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.

Randomization Arm 2: 70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.

Observational Arm 3: 50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-06
• Results First Submitted: 2017-08-04
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-11
• Last Update Submitted: 2020-03-11
• Results First Posted: 2020-03-13
• Last Update Posted: 2020-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Presence of a venous ulcer on the lower extremity for at least 12 weeks14 days
• Presence of lymphedema in the lower extremity for at least 14 days

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Exclusion Criteria

• Pregnant women or women of childbearing potential not on contraception
• Previous use of the pneumatic compression device
• Class IV congestive heart failure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Observational Arm 3	Flexitouch pneumonic compression	50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.
Randomization Arm 1:	Flexitouch for 1 month in addition to routine wound care	70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded
Randomization Arm 2:	Routine wound care for venous ulcers and lymphedema	70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.

Primary Outcome Measures

Name	Time	Method
To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire	30 days	Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.