An Exploratory, Double-Blind, Randomized, Placebo Controlled Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers

Genentech, Inc.0 sites50 target enrollmentAugust 2003

ConditionsFoot Ulcer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Foot Ulcer
Sponsor: Genentech, Inc.
Enrollment: 50
Primary Endpoint: Incidence of clinically significant hypotension.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is a Phase I, double blind, randomized, placebo-controlled study that will enroll approximately 50 adult subjects with Type 1 or Type 2 diabetes mellitus and chronic, diabetic foot ulcers. The study will be conducted at approximately 12 investigational sites in the United States.

Registry

clinicaltrials.gov

Start Date

August 2003

End Date

October 2004

Last Updated

8 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Genentech, Inc.

Eligibility Criteria

Inclusion Criteria

•Signed Informed Consent
•18-80 years old
•For females of childbearing potential, use of an effective method of contraception: abstinence; surgical sterilization; oral contraceptives; barrier contraception with either a condom, sponge, or diaphragm in conjunction with spermicidal gel; an intrauterine device (IUD); or contraceptive hormone implant or patch
•Type 1 or 2 diabetes mellitus
•Single, full-thickness (i.e., extending into the subcutaneous tissue or beyond) ulcer of the foot below the malleolus that does not involve bone, tendons, ligaments, or muscle
•Chronic ulcer with a duration of ≥ 4 weeks but \< 6 months
•Ulcer area with sharp debridement of ≥ 1.0 cm\^2 and ≤ 4.0 cm\^2
•Ankle-brachial index (ABI) of ≥ 0.6 and ≤ 1.2 on the study foot
•Glycosylated hemoglobin A1c (HbA1c) of ≤ 12%

Exclusion Criteria

•History of neoplasia or current neoplasia (with the exception of non-melanoma skin cancer)
•Proliferative diabetic retinopathy or wet age-related macular degeneration
•Active ulcer infection or cellulitis of any ulcer
•Ulcers with an etiology not related to diabetes (e.g., thermal, chemical, radiation insult)
•Connective tissue disease
•Active osteomyelitis of the study foot
•Subjects with ulcers related to an incompletely healed amputation wound
•Subjects with Charcot or other deformity of the study foot involving the study ulcer
•Immunosuppressive treatment, including radiation therapy, non-inhaled corticosteroids (inhaled corticosteroid ≤ 1000 ug daily dose is acceptable), and chemotherapy
•Pregnancy or lactation

Outcomes

Primary Outcomes

Incidence of clinically significant hypotension.

Secondary Outcomes

Incidence of adverse events
Percent reduction in total ulcer surface area.
Development of anti telbermin antibodies
Incidence of clinically significant ulcer infection defined by increased discharge and malodorous exudates from the ulcer, fever, and a white blood cell (WBC) count of >10,000/uL