- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02284373
Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
|
simultaneous wound care and pneumonic compression
|
Other: 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.
|
wound care /dressings
|
Other: 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.
|
pneumonic compression only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire
Time Frame: 30 days
|
Study was terminated due to inadequate enrollment.
No data was collected for this outcome measure.
|
30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-01568
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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