Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
NCT ID: NCT02284373
Last Updated: 2020-03-13
Study Results
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View full resultsBasic Information
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TERMINATED
NA
39 participants
INTERVENTIONAL
2011-05-31
2014-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Flexitouch for 1 month in addition to routine wound care
simultaneous wound care and pneumonic compression
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.
Routine wound care for venous ulcers and lymphedema
wound care /dressings
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.
Flexitouch pneumonic compression
pneumonic compression only
Interventions
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Flexitouch for 1 month in addition to routine wound care
simultaneous wound care and pneumonic compression
Routine wound care for venous ulcers and lymphedema
wound care /dressings
Flexitouch pneumonic compression
pneumonic compression only
Eligibility Criteria
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Inclusion Criteria
* Presence of lymphedema in the lower extremity for at least 14 days
Exclusion Criteria
* Previous use of the pneumatic compression device
* Class IV congestive heart failure
18 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Other Identifiers
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11-01568
Identifier Type: -
Identifier Source: org_study_id
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