Safety Study of Topical Human FGF-1 for Wound Healing

NCT00916292 | Unknown Phase 1

• 1 other identifier: Phage-W2009-01-1a
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Foot Ulcers

Keywords

Diabetes; dermal ulcers

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of a single dose of FGF-1 topically administered in normal volunteers given an artificial dermal wound

  1 week

Secondary Outcomes (1)

• Serum levels of FGF-1 after topical administration

  1 week

Study Arms (2)

Low dose

EXPERIMENTAL

Four subjects will receive low dose FGF-1

Drug: FGF-1 141

High Dose

EXPERIMENTAL

Four subjects will receive high dose FGF-1

Drug: FGF-1 141

Interventions

FGF-1 141 DRUG

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.

Low dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign an informed consent form prior to the initiation of any study procedures. Subjects must be competent to give written informed consent.
• Age must be between 18 to 75 years of age.
• 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.
• 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 In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed.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.

You may not qualify if:

• Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents or chemotherapy.
• Subjects who, at study entry, are taking systemic antibiotics.
• Subjects who are immunosuppressed.
• Subjects experiencing bacterial or viral infection or who may otherwise be febrile.
• 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.
• Life expectancy of less than 1 year.
• Active alcohol or drug abuse within 6 months prior to study entry.
• Screening liver function tests of more than 2.0 times the upper limit of normal.
• Serum creatinine of ≥ 2.5 mg/dl.
• Hemoglobin A1c (HgbA1c) of \>10%.
• Exposure to any other investigational drugs or devices or participation in any other investigational studies within 30 days prior to study entry.
• 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).

Sponsors & Collaborators

• Phage Pharmaceuticals, Inc.: lead

Study Sites (1)

Dedicated Phase I

Phoenix, Arizona, 85013, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Shawn Searle, MD

  Dedicated Phase I

  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: June 5, 2009
• First Posted: June 9, 2009
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 12, 2012

Record last verified: 2012-03

Locations

US (1)