Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- NYU Langone Health
- Enrollment
- 39
- Primary Endpoint
- To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported