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

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