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

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02284373
• Other study ID #: 11-01568
• Status: Terminated
• Phase: N/A
• Start date: May 2011
• Est. completion date: October 2014

Study information

• Verified date: March 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema
• Varicose Ulcer

Intervention

Other:
• 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

Device:
• Flexitouch pneumonic compression
pneumonic compression only

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire	Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.	30 days