A Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers

NCT00069446 | Completed Phase 1

• 1 other identifier: VGF2763g
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Foot Ulcer

Keywords

Diabetes; Diabetic; Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Incidence of clinically significant hypotension.

Secondary Outcomes (4)

• 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

• Development of anti telbermin antibodies

• Incidence of adverse events

• Percent reduction in total ulcer surface area.

Interventions

rhuMAb VEGF (telbermin) DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent
• 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%

You may not qualify if:

• 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
• Multiple ulcers in the study foot
• Renal failure (serum creatinine of \>3.0 mg/dL)
• Poor nutritional status (albumin of \<3.0 g/dL)
• Known hypersensitivity to any ingredients of telbermin, placebo, or vehicle, including excipients in the formulation of telbermin or placebo gel (trehalose dihydrate, polysorbate 20, succinic acetic acid, succinic acetic acid disodium, and hexahydrate)
• Known prior inability to complete required study visits during treatment period

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Foot Ulcer; Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Officials

• Tim Breen, Ph.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 25, 2003
• First Posted: September 26, 2003
• Study Start: August 1, 2003
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: May 11, 2017

Record last verified: 2017-05