Status:
COMPLETED
Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
Lead Sponsor:
Shire
Conditions:
Leg Ulcer
Varicose Ulcer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.
Detailed Description
Celaderm(TM) weekly for four weeks or biweekly for four treatments combined with Profore(R) compression vs. Profore(R) compression alone.
Eligibility Criteria
Inclusion
- venous ulcer \> 1 month and \< 12 months in duration; 2 to 20 sq cm in surface area; not infected
- confirmatory venous ultrasound showing prior DVT and concurrent venous reflux
- ankle-brachial index 0.80 or greater
Exclusion
- cutaneous malignancy
- recent treatment with corticosteroids or chemotherapeutic agents
- wound exposed bone, tendon or neurovascular structure
- wound infected and requiring antibiotics
Key Trial Info
Start Date :
January 31 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00399308
Start Date
January 31 2007
End Date
April 30 2008
Last Update
June 11 2021
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Dr. Robert Snyder
Tamarac, Florida, United States, 33321
2
National Center for Limb Preservation
Niles, Illinois, United States, 60714
3
Beth Israel Deaconess Medical Center, Division of Podiatry
Boston, Massachusetts, United States, 02215
4
State University of New York Stony Brook
Stony Brook, New York, United States, 11794