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

NCT02284373 | Terminated Results

• 1 other identifier: 11-01568
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Randomization Arm 1:

OTHER

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

Other: Flexitouch for 1 month in addition to routine wound care

Randomization Arm 2:

OTHER

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.

Other: Routine wound care for venous ulcers and lymphedema

Observational Arm 3

OTHER

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.

Device: Flexitouch pneumonic compression

Interventions

Flexitouch for 1 month in addition to routine wound care OTHER

simultaneous wound care and pneumonic compression

Randomization Arm 1:

Routine wound care for venous ulcers and lymphedema OTHER

wound care /dressings

Randomization Arm 2:

Flexitouch pneumonic compression DEVICE

pneumonic compression only

Observational Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women or women of childbearing potential not on contraception
• Previous use of the pneumatic compression device
• Class IV congestive heart failure

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Todd Berland, MD
• Organization: New York University Langone Medical Center

todd.berland@nyumc.org

212 263 5060

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This investigation is a randomized clinical trial of a prospective cohort of subjects with venous ulcers, with an observational cohort of 50 subjects with lymphedema. Venous ulcer subjects will be randomized into two arms

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: November 6, 2014
• Study Start: May 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 13, 2020
• Results First Posted: March 13, 2020

Record last verified: 2020-03