A Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor for Induction of Healing of Diabetic Foot Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00351767
First received: July 11, 2006
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Foot Ulcer, Diabetic
Drug: placebo
Drug: telbermin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Skin re-epithelialization without drainage or dressing requirements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete closure of the study ulcer [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Durability of closure [ Time Frame: Time to recurrence ] [ Designated as safety issue: No ]
  • Change and percent change in ulcer surface area [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Number of debridements performed [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: January 2006
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00351767

Sponsors and Collaborators
Genentech
Investigators
Study Director: Pual Kwon, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00351767     History of Changes
Other Study ID Numbers: VGF3554g
Study First Received: July 11, 2006
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Diabetes
Dabetic Feet

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

ClinicalTrials.gov processed this record on October 01, 2014