Working... Menu

A Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor for Induction of Healing of 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: NCT00351767
Recruitment Status : Completed
First Posted : July 13, 2006
Last Update Posted : January 25, 2013
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of three different doses of topically applied telbermin in subjects ≥ 18 years old with diabetic foot ulcers. Approximately 160 adult subjects with Type 1 or Type 2 diabetes mellitus will be enrolled at approximately 40 investigational sites in the United States and Canada.

Condition or disease Intervention/treatment Phase
Foot Ulcer, Diabetic Drug: placebo Drug: telbermin Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Diabetic Foot Ulcers
Study Start Date : January 2006
Actual Primary Completion Date : January 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: telbermin
Topically applied

Experimental: 2 Drug: telbermin
Topically applied

Experimental: 3 Drug: telbermin
Topically applied

Placebo Comparator: 4 Drug: placebo
Topically applied

Primary Outcome Measures :
  1. Skin re-epithelialization without drainage or dressing requirements [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Complete closure of the study ulcer [ Time Frame: 24 weeks ]
  2. Durability of closure [ Time Frame: Time to recurrence ]
  3. Change and percent change in ulcer surface area [ Time Frame: 12 and 24 weeks ]
  4. Number of debridements performed [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ability and willingness to comply with the following: study drug gel application and dressing changes as instructed; use offloading footwear and practice of rubbing prevention (shear injury) of the study ulcer for the duration of the study; adherence to study requirements or use of adequate caregiver assistance
  • For males and females of childbearing potential, use of an effective method of contraception
  • Type 1 or 2 diabetes mellitus
  • Inability to perceive 10 grams pressure in the peri-ulcer area using a Semmes-Weinstein 5.07 monofilament
  • At least one full thickness (i.e., extending into the subcutaneous tissue or beyond) ulcer of the foot at or below the malleolus that does not involve bone, tendons, ligaments, or muscle (University of Texas Classification System for Diabetic Foot Wounds, Stage 1a)
  • Estimated foot ulcer surface area, L x W, between ≥ 0.70 cm^2 and ≤ 5.0 cm^2 as measured at Treatment Day 1 Any subject who does not meet this criterion will not be eligible for randomization.
  • Eye examination (indirect ophthalmoscopy, fundus photography, or fluorescein angiography) within 6 months prior to randomization with no indication of proliferative diabetic retinopathy or wet age-related macular degeneration

Exclusion Criteria:

  • Presence of an active systemic or local cancer or tumor of any kind (with the exception of non-melanoma skin cancer)
  • Proliferative diabetic retinopathy or wet age-related macular degeneration
  • A history of pulmonary edema
  • Active congestive heart failure
  • Active infection or cellulitis of any ulcer on the study foot
  • Active osteomyelitis of the study foot
  • Active connective tissue disease
  • Study ulcers with an etiology not related to diabetes (e.g., thermal, chemical, radiation insult)
  • History of active Charcot foot of the study foot within 6 months of screening
  • Treatment with systemic corticosteroids (equivalent to > 10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents within 14 days prior to the first study drug gel application or likelihood to receive one of these therapies during study participation
  • Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation
  • Pregnancy or lactation
  • Presence of more than two full-thickness ulcers on the study foot
  • End-stage renal failure necessitating chronic hemodialysis or chronic ambulatory peritoneal dialysis
  • Poor nutritional status
  • Life expectancy of less than 3 years (in the opinion of the investigator)
  • Known hypersensitivity to any ingredients of telbermin, placebo, or vehicle, including excipients in the formulation of telbermin or placebo gel
  • Known prior inability to complete required study visits during study participation
  • A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the subject's medical history, which, in the opinion of the investigator, may pose a threat to subject compliance
  • Use of a platelet-derived growth factor within the 28 days prior to screening
  • Use of any investigational drug or therapy within the 28 days prior to screening

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): NCT00351767

Sponsors and Collaborators
Genentech, Inc.
Layout table for investigator information
Study Director: Pual Kwon, M.D. Genentech, Inc.

Layout table for additonal information
Responsible Party: Genentech, Inc. Identifier: NCT00351767     History of Changes
Other Study ID Numbers: VGF3554g
First Posted: July 13, 2006    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013

Keywords provided by Genentech, Inc.:
Dabetic Feet

Additional relevant MeSH terms:
Layout table for 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