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

This study has been completed.
Sponsor:
Collaborators:
RTS Family Foundation
New York State Department of Health
Information provided by:
Calvary Hospital, Bronx, NY
ClinicalTrials.gov Identifier:
NCT01079299
First received: March 2, 2010
Last updated: January 9, 2012
Last verified: August 2010

March 2, 2010
January 9, 2012
December 2007
April 2010   (final data collection date for primary outcome measure)
Median Time to Wound Closure at 9 Months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Median number of days for complete healing in each treatment group
Time to complete healing [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
time in weeks to complete wound closure and no need for a dressing
Complete list of historical versions of study NCT01079299 on ClinicalTrials.gov Archive Site
Not Provided
  • Rate of wound healing [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    relative rate of wound closure based on wound surface area
  • Lower leg Edema [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    circunference of ankle, calf, thigh
  • Wound pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    categorical pain scale 0f 1-10
  • Frequency of infection [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    incidence of local wound infections and serious infection (cellulitis)
Not Provided
Not Provided
 
Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema
Intermittent, Gradient, Pneumatic Compression Plus Standard Compression for Hard-To-Heal Venous Ulcers in Subjects With Secondary Lymphedema and Chronic Venous Insufficiency

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphedema
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)
  • Experimental: IPC plus standard compression
    Intervention: Device: Intermittent, gradient, pneumatic compression device
  • Active Comparator: Standard compression alone
    Intervention: Device: Intermittent, gradient, pneumatic compression device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
May 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
21 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01079299
CL-VU-0308
No
Oscar M. Alvarez, PhD / Principal Investigator, Center for curative and Palliative Wound Care, Calvary Hospital
Calvary Hospital, Bronx, NY
  • RTS Family Foundation
  • New York State Department of Health
Not Provided
Calvary Hospital, Bronx, NY
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP