ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01079299
Recruitment Status : Completed
First Posted : March 3, 2010
Results First Posted : February 10, 2012
Last Update Posted : February 10, 2012
Sponsor:
Collaborators:
RTS Family Foundation
New York State Department of Health
Information provided by:
Calvary Hospital, Bronx, NY

Brief Summary:
This is a randomized, controlled, parallel group, open label, clinical trial to evaluate the effectiveness of intermittent, gradient, pneumatic compression (IPC)on the healing of venous ulcers in subjects diagnosed with chronic secondary lymphedema. Time to complete healing, healing rates, edema, wound pain, granulation tissue, and wound exudate (type and amount) will be compared between the IPC-treated group (IPC plus standard compression)and control (standard compression alone).

Condition or disease Intervention/treatment Phase
Lymphedema Device: Intermittent, gradient, pneumatic compression device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intermittent, Gradient, Pneumatic Compression Plus Standard Compression for Hard-To-Heal Venous Ulcers in Subjects With Secondary Lymphedema and Chronic Venous Insufficiency
Study Start Date : December 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema
U.S. FDA Resources

Arm Intervention/treatment
Experimental: IPC plus standard compression Device: Intermittent, gradient, pneumatic compression device
lymphedema pump provides external compression in a segmental,gradient fashion
Other Name: Bio 4000 (Bio Compression Inc, Moonachie,NJ)
Active Comparator: Standard compression alone Device: Intermittent, gradient, pneumatic compression device
lymphedema pump provides external compression in a segmental,gradient fashion
Other Name: Bio 4000 (Bio Compression Inc, Moonachie,NJ)



Primary Outcome Measures :
  1. Median Time to Wound Closure at 9 Months [ Time Frame: 9 months ]
    Median number of days for complete healing in each treatment group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with secondary lymphedema
  • Presence of a venous ulcer that has not healed in more than 6 months
  • Localized wound pain greater than 3 with VAS
  • Ulcer must be on lower leg (below knee)
  • Ulcer must be of venous etiology
  • CVI proven by duplex studies
  • Subject must have adequate arterial blood flow (ABI > 0.70)
  • Subject must be able to tolerate compression bandages
  • Subject must be ambulatory
  • Capable of understanding consent process

Exclusion Criteria:

  • Wound infection
  • Ulcer of non-venous etiology
  • Ulcer on toes or plantar surface of the foot
  • Subject taking any medication that in the opinion of the investigator affects wound healing
  • Alcohol or drug abuse
  • Active deep venous thrombosis (DVT)
  • Subject has a cancer diagnosis
  • Diabetic with hemoglobin A1C>12
  • Arterial insufficiency ABI<0.70
  • Subject is not capable of walking (wheelchair-bound or bed-bound)
  • Subject currently enrolled in another clinical trial
  • Moderate to severe congestive heart failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01079299


Locations
United States, New York
Calvary Hospital, Center for Curative and Palliative Wound Care
Bronx, New York, United States, 10461
Sponsors and Collaborators
Calvary Hospital, Bronx, NY
RTS Family Foundation
New York State Department of Health

Responsible Party: Oscar M. Alvarez, PhD / Principal Investigator, Center for curative and Palliative Wound Care, Calvary Hospital
ClinicalTrials.gov Identifier: NCT01079299     History of Changes
Other Study ID Numbers: CL-VU-0308
First Posted: March 3, 2010    Key Record Dates
Results First Posted: February 10, 2012
Last Update Posted: February 10, 2012
Last Verified: August 2010

Keywords provided by Calvary Hospital, Bronx, NY:
venous ulcer
secondary lymphedema
chronic lower leg ulceration

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases