Trials / Terminated
TerminatedNCT02284373
Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Flexitouch for 1 month in addition to routine wound care | simultaneous wound care and pneumonic compression |
| OTHER | Routine wound care for venous ulcers and lymphedema | wound care /dressings |
| DEVICE | Flexitouch pneumonic compression | pneumonic compression only |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2014-09-01
- Completion
- 2014-10-01
- First posted
- 2014-11-06
- Last updated
- 2020-03-13
- Results posted
- 2020-03-13
Source: ClinicalTrials.gov record NCT02284373. Inclusion in this directory is not an endorsement.