Foot Ulcer, DiabeticPhase 2NCT00351767
A Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor for Induction of Healing of Diabetic Foot Ulcers
A Phase 2 study testing telbermin in people with Foot Ulcer, Diabetic, run by Genentech, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- telbermin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jan 2008
- Phase
- Phase 2
- 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
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
About this study
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
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.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- placebo, telbermin
- Keywords
- Diabetes, Dabetic Feet
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Topically applied
telberminDrug
Topically applied
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: telbermin |
| 2 | Experimental | Not described Receives: Drug: telbermin |
| 3 | Experimental | Not described Receives: Drug: telbermin |
| 4 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin re-epithelialization without drainage or dressing requirements
Measured: 12 weeks
Secondary outcomes (4)
Complete closure of the study ulcer
Measured: 24 weeks
Durability of closure
Measured: Time to recurrence
Change and percent change in ulcer surface area
Measured: 12 and 24 weeks
Number of debridements performed
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pual Kwon, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351767
- Sponsor's protocol ID
- VGF3554g
- Status last verified
- Jan 2013
- First submitted
- 11 Jul 2006
- Last updated
- 25 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00351767
- Acronym / sponsor ID
- VGF3554g
- Conditions
- Foot Ulcer, Diabetic
- Keywords
- Diabetes, Dabetic Feet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jan 2008 (actual)
- First posted
- 13 Jul 2006 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: telbermin |
| 2 | Experimental | Drug: telbermin |
| 3 | Experimental | Drug: telbermin |
| 4 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
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 |
|---|---|---|
| placeboTopically applied | Drug | 4 |
| telberminTopically applied | Drug | 1, 2, 3 |
Primary outcome
Skin re-epithelialization without drainage or dressing requirements
Time frame: 12 weeks
4 secondary outcomes
Complete closure of the study ulcer
Time frame: 24 weeks
Durability of closure
Time frame: Time to recurrence
Change and percent change in ulcer surface area
Time frame: 12 and 24 weeks
Number of debridements performed
Time frame: 12 weeks
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 25 Jan 2013.
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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.
Pual Kwon, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing telbermin in people with Foot Ulcer, Diabetic, 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 7 inclusion and 21 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 25 Jan 2013. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Skin re-epithelialization without drainage or dressing requirements (time frame: 12 weeks). 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 25 Jan 2013.