Lymphedema Clinical Trial
Official title:
Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
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.
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.
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