Status:
COMPLETED
FGF-1 for Topical Administration for the Treatment of Diabetic or Venous Stasis Ulcers
Lead Sponsor:
CardioVascular BioTherapeutics, Inc.
Collaborating Sponsors:
Warren General Hospital
Conditions:
Chronic Wounds
Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
FGF-1 is being used for the treatment of patients with diabetic or venous stasis ulcers. Procedure includes topical administration of FGF-1 or placebo and evaluation of safety, pharmacokinetics, and w...
Detailed Description
Patients meeting eligibility criteria will be randomized to receive topical administration of either FGF-1 or placebo. Patients will be evaluated at days 1 and 7, post-treatment for safety, pharmacoki...
Eligibility Criteria
Inclusion
- Eligibility Criteria:
- Informed consent
- Female patients post-menopausal, sterilized, or on adequate birth control
- Full-thickness lower extremity diabetic or venous statis ulcers of specific target size and of at least 8 weeks but no more than 1 year duration
- Target ulcer freshly debrided at screening or within two weeks prior to screening
- Adequate blood supply defined by transcutaneous oxygen pressure \> 20 mmHG and ABI greater than or equal to 0.4
- Compliance with non-weight bearing regimen in diabetic patients
- Compliance with wound care regimen
Exclusion
Key Trial Info
Start Date :
September 2 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00425178
Start Date
September 2 2005
End Date
December 1 2006
Last Update
November 1 2019
Active Locations (1)
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1
Warren General Hospital
Warren, Pennsylvania, United States, 16365