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

Calvary Hospital, Bronx, NY1 site in 1 country52 target enrollmentDecember 2007

ConditionsLymphedema

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lymphedema
Sponsor: Calvary Hospital, Bronx, NY
Enrollment: 52
Locations: 1
Primary Endpoint: Median Time to Wound Closure at 9 Months
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

May 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Calvary Hospital, Bronx, NY

Eligibility 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)