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

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).

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Key information

Conditions

Lymphedema Cardiovascular Diseases Hemic and Lymphatic Diseases Leg Ulcer Lymphatic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

21 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Calvary Hospital, Center for Curative and Palliative Wound Care

The Bronx, New York, 10461, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent, gradient, pneumatic compression device

Device

lymphedema pump provides external compression in a segmental,gradient fashion

Other names: Bio 4000 (Bio Compression Inc, Moonachie,NJ)

Primary outcomes

Median Time to Wound Closure at 9 Months

Time frame: 9 months

Median number of days for complete healing in each treatment group

Sponsors and collaborators

Lead sponsor

Calvary Hospital, Bronx, NY

Other

Collaborators

New York State Department of Health
RTS Family Foundation

Registry information

Official study title

Intermittent, Gradient, Pneumatic Compression Plus Standard Compression for Hard-To-Heal Venous Ulcers in Subjects With Secondary Lymphedema and Chronic Venous Insufficiency

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Mar 3, 2010
Registry last updated: Feb 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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