Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Venturis Therapeutics, Inc.
With
Warren General Hospital
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, pharmacokinetics, and wound healing.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
