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Safety Study of Topical Human FGF-1 for Wound Healing

This study is not yet open for participant recruitment.
Verified March 2012 by Phage Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Phage Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00916292
First received: June 5, 2009
Last updated: March 9, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of the study is to see if FGF-1 is safe when applied topically to the surface of a wound.


Condition Intervention Phase
Diabetic Foot Ulcers
 Drug: FGF-1 141
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1a, Open Label, Single Dose, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Normal Volunteers Given Punch Skin Biopsies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Phage Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of a single dose of FGF-1 topically administered in normal volunteers given an artificial dermal wound [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum levels of FGF-1 after topical administration [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8
Study Start Date: November 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose
Four subjects will receive low dose FGF-1
 Drug: FGF-1 141
Each subject will receive two, 3 mm squared punch skin biopsies, one biopsy will receive the study drug, and the second biopsy will remain untreated as a control. Low dose: FGF-1, 0.3 mg per square centimeter.
Experimental: High Dose
Four subjects will receive high dose FGF-1
 Drug: FGF-1 141
Each subject will receive two, 3 mm squared punch skin biopsies, one biopsy will receive the study drug, and the second biopsy will remain untreated as a control. High dose: FGF-1, 3.0 mg per square centimeter.

Detailed Description:

Dermal ulcers pose a significant healthcare problem in the United States, ultimately affecting 10-15% of the approximately 20 million patients with diabetes and a similar number of patients with chronic venous insufficiency. Dermal leg and foot ulcers can result from compromised arterial inflow, microvascular perfusion or venous outflow which can lead to amputation unless vascular perfusion is improved. FGF-1 for topical administration offers the possibility of improved microvascular perfusion by promoting the formation of new blood vessels in the wound bed resulting in enhanced development of granulation tissue and accelerated healing.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Sign an informed consent form prior to the initiation of any study procedures. Subjects must be competent to give written informed consent.
  2. Age must be between 18 to 75 years of age.
  3. Female subject must be post-menopausal or sterilized, or if she is of childbearing potential, she is not breast feeding, and her serum pregnancy test is negative.
  4. Subjects must be willing to change their wound dressings daily and demonstrate to study personnel the ability to follow the dressing care instructions indicated in the Appendix. Subjects considered eligible to enter the study must sign an informed consent form prior to the initiation of any study procedures. In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed. Subjects must be competent to give written informed consent.

Exclusion Criteria:

  1. Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents or chemotherapy.
  2. Subjects who, at study entry, are taking systemic antibiotics.
  3. Subjects who are immunosuppressed.
  4. Subjects experiencing bacterial or viral infection or who may otherwise be febrile.
  5. Past history or current presence of any type of cancer (except past history of basal cell carcinoma that is not on the limb being treated). Subjects with existing BCC will be excluded from the study.
  6. Life expectancy of less than 1 year.
  7. Active alcohol or drug abuse within 6 months prior to study entry.
  8. Screening liver function tests of more than 2.0 times the upper limit of normal.
  9. Serum creatinine of ≥ 2.5 mg/dl.
  10. Hemoglobin A1c (HgbA1c) of >10%.
  11. Exposure to any other investigational drugs or devices or participation in any other investigational studies within 30 days prior to study entry.
  12. Any other medical, social, or geographical factor that would make it unlikely that the subject will comply with study procedures (e.g., alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or a history of non-compliance).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916292

Locations
United States, Arizona
Dedicated Phase I Not yet recruiting
Phoenix, Arizona, United States, 85013
Contact: Shawn Searle, MD     602-279-7300        
Sponsors and Collaborators
Phage Pharmaceuticals, Inc.
Investigators
Principal Investigator: Shawn Searle, MD Dedicated Phase I
  More Information

No publications provided

Responsible Party: Phage Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00916292     History of Changes
Other Study ID Numbers: Phage-W2009-01-1a
Study First Received: June 5, 2009
Last Updated: March 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Phage Pharmaceuticals, Inc.:
Diabetes
dermal ulcers

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
 Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on May 21, 2013