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

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00069446

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 I

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Diabetes Diabetic Foot Foot Health

Drug Information available for: Telbermin

U.S. FDA Resources

Further study details as provided by Genentech:

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

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

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Tim Breen, Ph.D.

Genentech

More Information

No publications provided

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

Keywords provided by Genentech:

Diabetes
Diabetic
Diabetic Foot Ulcer

Additional relevant MeSH terms:

Foot Ulcer
Molecular Mechanisms of Pharmacological Action
Diabetic Neuropathies
Skin Diseases
Growth Substances
Ulcer
Physiological Effects of Drugs
Mitosis Modulators
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases

Endothelial Growth Factors
Foot Diseases
Pharmacologic Actions
Diabetic Angiopathies
Pathologic Processes
Mitogens
Cardiovascular Diseases
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

ClinicalTrials.gov processed this record on November 30, 2009