Effectiveness of XCell on Autolytic Debridement of Venous Ulcers

Completed · Not applicable

Conditions studied: Venous Ulcer

In brief

This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for its ability to naturally (autolytically) remove nonviable tissue and create a healthy vascular wound bed. Results will compare venous ulcers treated with Xylos XCell cellulose dressing plus standard care to those treated with standard care alone. The hypothesis is that XCell will demonstrate more autolytic debridement than the standard of care.

Key facts

Study ID

NCT00446823

Run by

Xylos Corporation

People needed

50

Starts

2002-06-01

Expected to finish

2003-12-01

Last updated by the study team

2007-03-13

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients of any race and are between 18 and 90 years of age.
• Patients that are able to understand and are willing to give written informed consent.
• Patients that have a non-healing open venous ulcer for at least one month.
• Patients that have greater than 50% of the ulcers surface area covered with non-viable tissue such as fibrin slough, dry crust or a combination of both.
• Patients that have the clinical signs and symptoms of venous ulceration such as varicosities, hyper pigmentation, stasis dermatitis, lipodermatosclerosis, and edema.
• Patients that have a venous ulcer with a surface area of greater than or equal to 1.5 cm2.
• Patients that have an ankle to brachial index (ABI) > 0.70.

You may not qualify if…

• Study wound (target ulcer) etiology is other than venous insufficiency.
• Patient has peripheral arterial disease as determined by the following criteria: Ankle/Brachial Index < 0.7 (ulcerated leg), evidence of intermittent claudication.
• Patient has the presence of any of the following in the area of the ulcer: cellulitis, osteomyelitis, and ulcer with exposed bone, tendon or fascia.
• Patient has a known hypersensitivity to dressing components.
• Patient is receiving corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy where in the investigator's opinion could interfere with wound healing .
• Patient is known to have uncontrolled diabetes mellitus (as defined by the investigator).
• Patient is known to have immunodeficiency disorders that interfere with wound healing.
• Patient has a history of sickle cell anemia, thalassemia, vasculitis, rheumatoid arthritis, lupus erythematosus, polyarteritis nodosa, scleroderma or any connective tissue or collagen vascular disorder.
• Patient has wounds that have been treated with an investigational product within the past thirty days.
• Patient has not signed the informed consent.

Where it is running

• Boston University School of Medicine — Boston, Massachusetts, United States
• University Wound Care Center — The Bronx, New York, United States
• Etris Associates — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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