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

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ClinicalTrials.gov Identifier: NCT02284373
Recruitment Status : Terminated (Inadequate enrollment)
First Posted : November 6, 2014
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Lymphedema Other: Flexitouch for 1 month in addition to routine wound care Other: Routine wound care for venous ulcers and lymphedema Device: Flexitouch pneumonic compression Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
Study Start Date : May 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
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
Other: Flexitouch for 1 month in addition to routine wound care
simultaneous wound care and pneumonic compression

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.
Other: Routine wound care for venous ulcers and lymphedema
wound care /dressings

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.
Device: Flexitouch pneumonic compression
pneumonic compression only




Primary Outcome Measures :
  1. To assess quality of life in patients with lymphedema and venous ulcers using CIVIQ-2 self questionnaire [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02284373     History of Changes
Other Study ID Numbers: 11-01568
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Lymphedema
Varicose Ulcer
Lymphatic Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases