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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 2, 2010
Last Updated Date	January 9, 2012
Start Date ^ICMJE	December 2007
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 9, 2012)	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
Original Primary Outcome Measures ^ICMJE (submitted: March 2, 2010)	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
Change History	Complete list of historical versions of study NCT01079299 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE (submitted: March 2, 2010)	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)
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema
Official Title ^ICMJE	Intermittent, Gradient, Pneumatic Compression Plus Standard Compression for Hard-To-Heal Venous Ulcers in Subjects With Secondary Lymphedema and Chronic Venous Insufficiency
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Lymphedema
Intervention ^ICMJE	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)
Study Arm (s)	Experimental: IPC plus standard compression Intervention: Device: Intermittent, gradient, pneumatic compression device Active Comparator: Standard compression alone Intervention: Device: Intermittent, gradient, pneumatic compression device
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	52
Completion Date	May 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	21 Years to 95 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01079299
Other Study ID Numbers ^ICMJE	CL-VU-0308
Has Data Monitoring Committee	No
Responsible Party	Oscar M. Alvarez, PhD / Principal Investigator, Center for curative and Palliative Wound Care, Calvary Hospital
Study Sponsor ^ICMJE	Calvary Hospital, Bronx, NY
Collaborators ^ICMJE	RTS Family Foundation New York State Department of Health
Investigators ^ICMJE	Not Provided
Information Provided By	Calvary Hospital, Bronx, NY
Verification Date	August 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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