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Completed

NCT Number: NCT00069446

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

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.

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Key information

Conditions

Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Diseases Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rhuMAb VEGF (telbermin)

Drug

Primary outcomes

  1. Incidence of clinically significant hypotension.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Sep 26, 2003
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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