Status:
COMPLETED
Effectiveness of XCell on Autolytic Debridement of Venous Ulcers
Lead Sponsor:
Xylos Corporation
Conditions:
Venous Ulcer
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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. R...
Detailed Description
Chronic wounds are a problem for both the patient and the health care provider. The definition of a chronic wound is one that deviates from the expected sequence of repair in time, appearance and resp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2003
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00446823
Start Date
June 1 2002
End Date
December 1 2003
Last Update
March 13 2007
Active Locations (3)
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1
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
2
University Wound Care Center
The Bronx, New York, United States, 10461
3
Etris Associates
Philadelphia, Pennsylvania, United States, 19116