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

Primary Purpose

Chronic Wounds, Diabetes, Venous Stasis Ulcers

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

FGF-1

About this trial

This is an interventional treatment trial for Chronic Wounds focused on measuring Chronic wounds, Diabetes, Ulcers, Arterial bypass, Angioplasty, Diabetic ulcers

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Warren General Hospital

Outcomes

Primary Outcome Measures

Safety

Pharmacokinetics

Secondary Outcome Measures

Wound improvement

Full Information

NCT ID

NCT00425178

First Posted

January 18, 2007

Last Updated

October 31, 2019

Sponsor

CardioVascular BioTherapeutics, Inc.

Collaborators

Warren General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00425178

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

September 2, 2005 (Actual)

Primary Completion Date

September 2, 2006 (Actual)

Study Completion Date

December 1, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CardioVascular BioTherapeutics, Inc.

Collaborators

Warren General Hospital

4. Oversight

5. Study Description

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.

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, pharmacokinetics, and wound healing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Wounds, Diabetes, Venous Stasis Ulcers

Keywords

Chronic wounds, Diabetes, Ulcers, Arterial bypass, Angioplasty, Diabetic ulcers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

FGF-1

Primary Outcome Measure Information:

Title

Safety

Title

Pharmacokinetics

Secondary Outcome Measure Information:

Title

Wound improvement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas E Serena, MD

Organizational Affiliation

Warren General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Warren General Hospital

City

Warren

State/Province

Pennsylvania

ZIP/Postal Code

16365

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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