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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00069446
Recruitment Status : Completed
First Posted : September 26, 2003
Last Update Posted : May 11, 2017
Information provided by:
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Foot Ulcer Drug: rhuMAb VEGF (telbermin) Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 2003
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Incidence of clinically significant hypotension.

Secondary Outcome Measures :
  1. 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
  2. Development of anti telbermin antibodies
  3. Incidence of adverse events
  4. Percent reduction in total ulcer surface area.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • 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
  • Use of any other investigational drug or therapy on the study foot within the past month
  • Previous use of a platelet-derived or other growth factors on the study ulcer within the past 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00069446

Sponsors and Collaborators
Genentech, Inc.
Study Director: Tim Breen, Ph.D. Genentech, Inc. Identifier: NCT00069446     History of Changes
Other Study ID Numbers: VGF2763g
First Posted: September 26, 2003    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by Genentech, Inc.:
Diabetic Foot Ulcer

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Endothelial Growth Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs