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

Calvary Hospital, Bronx, NY

Status

Completed

Conditions

Lymphedema

Treatments

Device: Intermittent, gradient, pneumatic compression device

Study type

Interventional

Funder types

Other

Identifiers

NCT01079299

CL-VU-0308

Details and patient eligibility

About

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).

Enrollment

52 patients

Sex

All

Ages

21 to 95 years old

Volunteers

No Healthy Volunteers

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