Trial | NCT00425178  Report issue

Title

FGF-1 for Topical Administration for the Treatment of Diabetic or Venous Stasis Ulcers
A Phase 1, Open Label, Single Dose, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Patients With Diabetic or Venous Stasis Ulcers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fgf-1 ...

  • Study Participants

    8
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.
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.
Study Started
Sep 02
2005
Primary Completion
Sep 02
2006
Study Completion
Dec 01
2006
Last Update
Nov 01
2019

Drug FGF-1

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
No Results Posted