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

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00069446
First received: September 25, 2003
Last updated: December 8, 2006
Last verified: December 2006
  Purpose

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 Intervention Phase
Foot Ulcer
Drug: rhuMAb VEGF (telbermin)
Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence of clinically significant hypotension.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 50
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069446

Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Tim Breen, Ph.D. Genentech, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00069446     History of Changes
Other Study ID Numbers: VGF2763g
Study First Received: September 25, 2003
Last Updated: December 8, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
Diabetes
Diabetic
Diabetic Foot Ulcer

Additional relevant MeSH terms:
Ulcer
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
Mitogens
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014