NCT00069446

CompletedPhase 1

A Study Evaluating Topical Recombinant Human Vascular Endoth...

Genentech, Inc.Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

VGF2763g

Study Type

interventional

Reported enrollment (type unavailable)

50

Locations

0 countries

Sites

N/A

Timeline

Study Start

August 2003

Actual (reported)

Primary Completion

October 2004

Actual (reported)

Study Completion

October 2004

Actual (reported)

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 50 participants
Study completion date: October 2004
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2003
Actual (reported)
First Submitted
September 25, 2003
Actual (reported)
First Posted
September 26, 2003
Actual (reported)
Primary Completion
October 2004
Actual (reported)
Study Completion
October 2004
Actual (reported)

Last Updated: May 11, 2017
Status Verified: May 2017
Last Update Submitted: May 9, 2017

Conditions

Foot Ulcer

Keywords

DiabetesDiabeticDiabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

Incidence of clinically significant hypotension.

Secondary Outcomes (4)

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.

Interventions

rhuMAb VEGF (telbermin)Drug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed Informed Consent
years old

Sponsors & Collaborators

Genentech, Inc.
Industrylead

MeSH Terms

Conditions

Foot UlcerDiabetes MellitusDiabetic Foot

Condition Hierarchy (Ancestors)

Foot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeg UlcerSkin UlcerGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular Diseases

Study Officials

Tim Breen, Ph.D.
Genentech, Inc.
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 1
Purpose: TREATMENT
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 25, 2003

First Posted

September 26, 2003

Study Start

August 2003

Actual (reported)

Primary Completion

October 2004

Actual (reported)

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Phase 2Completed

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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%

You may not qualify if:

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
+2 more criteria

Contact the study team to confirm eligibility.

Diabetes Complications

Diabetic Neuropathies

Study Completion

October 2004

Actual (reported)

Last Updated

May 11, 2017

Record last verified: 2017-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00069446
Data provider: ClinicalTrials.gov
Source updated: 2017-05-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:12 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record