Status:
COMPLETED
Taliderm Dressing for Venous Ulcers
Lead Sponsor:
Medical University of South Carolina
Conditions:
Venous Stasis Ulcers
Venous Insufficiency
Eligibility:
All Genders
45+ years
Phase:
EARLY_PHASE1
Brief Summary
The study will test a new wound healing dressing called Taliderm® on leg ulcers caused by chronic venous insufficiency (CVI). Some people with CVI have poor vein circulation that causes ulcers to deve...
Eligibility Criteria
Inclusion
- Adults ≥45 years of age
- Diagnosis venous partial thickness ulcer diagnosed within the past
- 4 weeks without recent enzymatic, autolytic or chemical treatment
- Viable and clean wound bed with granulation tissue and ≥ 90% free of necrotic debris
- Wound measures between 5 and 20 cm2
- Extends through epidermis and into the dermis
Exclusion
- Full thickness ulcers extending beyond the dermis
- Current wound, skin, or systemic infection
- Wound bed ≤90% free of necrotic debris
- Recent treatment with enzymatic, autolytic or chemical agents
- History or collagen vascular disease, severe arterial disease, organ transplant, Charcot, sickle cell
- Insufficient blood supply to ulcer (ankle-brachial index \<.8 or \>1.3)
- History of radiation therapy to the site
- Cellulitis/osteomyelitis/avascular ulcer bed
- Currently receiving hemodialysis
- Pregnancy
- Currently receiving treatment with another investigational drug or device or within the past 30 days
- Unable to comply with the study protocol
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00720239
Start Date
February 1 2008
End Date
August 1 2010
Last Update
February 22 2013
Active Locations (1)
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1
Roper St. Francis Hospitals
Charleston, South Carolina, United States, 29401