FGF-1 for Topical Administration for the Treatment of Diabetic or Venous Stasis Ulcers

CardioVascular BioTherapeutics

Status and phase: Completed; Phase 1

Conditions: Diabetes; Chronic Wounds; Venous Stasis Ulcers

Treatments: Drug: FGF-1

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00425178

CVBT-W2005-01

Details and patient eligibility

About

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 wound improvement.

Full 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, pharmacokinetics, and wound healing.

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)