Back to resultsRandomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
Primary Purpose
Lymphedema
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Flexitouch for 1 month in addition to routine wound care
Routine wound care for venous ulcers and lymphedema
Flexitouch pneumonic compression
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema
Eligibility Criteria
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
Exclusion Criteria:
- Pregnant women or women of childbearing potential not on contraception
- Previous use of the pneumatic compression device
- Class IV congestive heart failure
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Randomization Arm 1:
Randomization Arm 2:
Observational Arm 3
Arm Description
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
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.
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.
Outcomes
Primary Outcome Measures
To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire
Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02284373
Brief Title
Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
Official Title
Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Inadequate enrollment
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This investigation is a randomized clinical trial of a prospective cohort of subjects with venous ulcers, with an observational cohort of 50 subjects with lymphedema. Venous ulcer subjects will be randomized into two arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Randomization Arm 1:
Arm Type
Other
Arm Description
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
Arm Title
Randomization Arm 2:
Arm Type
Other
Arm Description
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.
Arm Title
Observational Arm 3
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Flexitouch for 1 month in addition to routine wound care
Intervention Description
simultaneous wound care and pneumonic compression
Intervention Type
Other
Intervention Name(s)
Routine wound care for venous ulcers and lymphedema
Intervention Description
wound care /dressings
Intervention Type
Device
Intervention Name(s)
Flexitouch pneumonic compression
Intervention Description
pneumonic compression only
Primary Outcome Measure Information:
Title
To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire
Description
Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Exclusion Criteria:
Pregnant women or women of childbearing potential not on contraception
Previous use of the pneumatic compression device
Class IV congestive heart failure
12. IPD Sharing Statement
Learn more about this trial
Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
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