Foot UlcerPhase 1NCT00069446
A Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers
A Phase 1 study testing rhuMAb VEGF (telbermin) in people with Foot Ulcer, run by Genentech, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Foot Ulcer
- What is being tested?
- rhuMAb VEGF (telbermin)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Oct 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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%
Who cannot join
- 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
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- 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
About this study
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
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.
- Conditions
- Foot Ulcer
- Being tested
- rhuMAb VEGF (telbermin)
- Keywords
- Diabetes, Diabetic, Diabetic Foot Ulcer
- Medical subject headings
- Foot Ulcer, Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhuMAb VEGF (telbermin)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2003 (estimated)
- Study startAug 2003
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot UlcerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tim Breen, Ph.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069446
- Sponsor's protocol ID
- VGF2763g
- Status last verified
- May 2017
- First submitted
- 25 Sep 2003
- Last updated
- 11 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00069446
- Acronym / sponsor ID
- VGF2763g
- Conditions
- Foot Ulcer
- Keywords
- Diabetes, Diabetic, Diabetic Foot Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2003 (actual)
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 26 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhuMAb VEGF (telbermin) | Drug | – |
Primary outcome
Incidence of clinically significant hypotension.
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Breen, Ph.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rhuMAb VEGF (telbermin) in people with Foot Ulcer, run by Genentech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinically significant hypotension.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.