NCT00425178

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 wound improvement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2007

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

January 18, 2007

Last Update Submit

October 31, 2019

Conditions

Chronic WoundsDiabetesVenous Stasis Ulcers

Keywords

Chronic woundsDiabetesUlcersArterial bypassAngioplastyDiabetic ulcers

Outcome Measures

Primary Outcomes (2)

  • Safety

  • Pharmacokinetics

Secondary Outcomes (1)

  • Wound improvement

Interventions

FGF-1DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren General Hospital

Warren, Pennsylvania, 16365, United States

Location

MeSH Terms

Conditions

Diabetes MellitusVaricose UlcerUlcer

Interventions

Fibroblast Growth Factor 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVaricose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibroblast Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Thomas E Serena, MD

    Warren General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2007

First Posted

January 22, 2007

Study Start

September 2, 2005

Primary Completion

September 2, 2006

Study Completion

December 1, 2006

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

US(1)