Foot UlcerPhase 3NCT00034788
A Study on the Efficacy and Safety of Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers With REGRANEX
A Phase 3 study testing Becaplermin in people with Foot Ulcer and Diabetic Foot, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of REGRANEX® Gel compared with placebo when applied for up to 52 consecutive weeks to recurring or non-healing ulcers of the ankle or foot related to diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Foot Ulcer, Diabetic Foot, Skin Ulcer
- What is being tested?
- Becaplermin
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Dec 2000to Feb 2004
- Phase
- Phase 3
- 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
- Diagnosis of Type I or Type II diabetes mellitus and a glycohemoglobin A1c<12%
- Minimum of one neuropathic, diabetic ulcer meeting the following criteria: stage III or IV, located on the distal lower extremity, between 1 and 15 square centimeters
- No exposed bone at the ulcer site
- No osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure
- Adequate arterial circulation to the foot
- New ulcers must be meet the following criteria: full-thickness ulcer (Stage III or IV), located on feet or ankles, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure
- Recurrent ulcers must meet the following criteria: stage II, III or IV, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure
- Females must be postmenopausal, surgically incapable of childbearing, or using an acceptable method of birth control and have negative pregnancy test
Who cannot join
- Hypersensitivity to REGRANEX® Gel or one of its components
- Presence of more than two full-thickness diabetic ulcers on either lower extremity
- presence of an active systemic or local cancer or tumor of any kind
- Use of topical antibiotics, antiseptics, enzymatic debriders, or any other agents on the selected ulcers, within the seven days preceding randomization
- Active rheumatic or collagen vascular disease or pre-existing conditions or diseases which may interfere with the evaluation of safety or efficacy of Regranex
- Systemic corticosteroid maintenance therapy, immunosuppressive or chemotherapeutic agents within 14 days prior to first study drug application or are likely to receive one of these therapies during study participation
- Radiation therapy that included the distal lower extremity, at any time in patient's life
- Charcot deformity (rocker bottom foot)
About this study
Official title: A Multicenter Clinical Evaluation of the Efficacy and Safety of REGRANEX Gel in the Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers
The purpose of this study is to evaluate the efficacy and safety of REGRANEX® Gel compared with placebo when applied for up to 52 consecutive weeks to recurring or non-healing ulcers of the ankle or foot related to diabetes.
Read the detailed description
This study has an initial open-label treatment period of up to 20 weeks with REGRANEX® gel for ulcers of the ankle or foot related to diabetes mellitus. Gel is applied once a day in a thin layer to cover the entire surface of the ulcer; then a non-adherent dressing and gauze are used to cover the gel. If all ulcers are healed during this open-label period, and if they remain healed after 24 weeks of observation, the patient discontinues the study. If one or more ulcers are not healed during the 20 weeks, of if an ulcer recurs or a new ulcer is observed during up to 24 weeks of observation, then the patient enters Double-blind Phase #1 during which neither the patient nor the physician knows whether the study drug or placebo is being applied to the ulcer. This Phase #1 may continue for up to 52 weeks. If one or more ulcers are not healed during 52 weeks of treatment, the patient discontinues the study. If all ulcers are healed during this phase, and if they remain healed after 24 weeks of observation, the patient discontinues the study. If an ulcer recurs or a new ulcer is observed during the observation period following Phase #1 treatment, then the patient enters Double-blind Phase #2 of the study for up to 20 weeks. If the ulcer is healed during Phase #2 treatment, the patient discontinues from the study at that time. If the ulcer remains unhealed after 20 weeks of Phase #2, the study is stopped. Efficacy assessments include the time to complete healing of the ulcer, the incidence of complete ulcer healing, and the reduction in total ulcer area at the end of the study. Safety assessments include the incidence of adverse events throughout the study, changes in clinical laboratory tests (hematology, chemistry, urinalysis), measurement of vital signs at specified intervals, and physical examinations at the start and end of the study. The study hypothesis is that the time to complete healing of diabetic foot ulcers with continued treatment using REGRANEX® is shorter than the time to healing with placebo and that the patients will well tolerate the medication. REGRANEX® gel (or placebo) applied to cover the entire surface of the ulcer, once a day for up to 52 weeks
- Conditions
- Foot Ulcer, Diabetic Foot, Skin Ulcer, Diabetic Neuropathies
- Being tested
- Becaplermin
- Keywords
- Regranex, Foot ulcers, Diabetes, Diabetes mellitus, Diabetic foot
- Medical subject headings
- Foot Ulcer, Diabetic Foot, Skin Ulcer, Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BecaplerminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete ulcer healing.
Secondary outcomes (1)
Incidence of complete ulcer healing and reduction in total ulcer area at end of study. Incidence of adverse events throughout study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startDec 2000
- Study completionFeb 2004
Why it stopped: Slow recruitment; Study did not address safety concern raised by European Medicines Agency
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034788
- Sponsor's protocol ID
- CR003238
- Status last verified
- Mar 2010
- First submitted
- 2 May 2002
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Evaluation of the Efficacy and Safety of REGRANEX Gel in the Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers
- ClinicalTrials.gov ID
- NCT00034788
- Acronym / sponsor ID
- CR003238
- Conditions
- Foot Ulcer, Diabetic Foot, Skin Ulcer, Diabetic Neuropathies
- Keywords
- Regranex, Foot ulcers, Diabetes, Diabetes mellitus, Diabetic foot
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment; Study did not address safety concern raised by European Medicines Agency
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Dec 2000
- Study completion
- Feb 2004 (actual)
- First posted
- 3 May 2002 (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.
The purpose of this study is to evaluate the efficacy and safety of REGRANEX® Gel compared with placebo when applied for up to 52 consecutive weeks to recurring or non-healing ulcers of the ankle or foot related to diabetes.
Detailed description
This study has an initial open-label treatment period of up to 20 weeks with REGRANEX® gel for ulcers of the ankle or foot related to diabetes mellitus. Gel is applied once a day in a thin layer to cover the entire surface of the ulcer; then a non-adherent dressing and gauze are used to cover the gel. If all ulcers are healed during this open-label period, and if they remain healed after 24 weeks of observation, the patient discontinues the study. If one or more ulcers are not healed during the 20 weeks, of if an ulcer recurs or a new ulcer is observed during up to 24 weeks of observation, then the patient enters Double-blind Phase #1 during which neither the patient nor the physician knows whether the study drug or placebo is being applied to the ulcer. This Phase #1 may continue for up to 52 weeks. If one or more ulcers are not healed during 52 weeks of treatment, the patient discontinues the study. If all ulcers are healed during this phase, and if they remain healed after 24 weeks of observation, the patient discontinues the study. If an ulcer recurs or a new ulcer is observed during the observation period following Phase #1 treatment, then the patient enters Double-blind Phase #2 of the study for up to 20 weeks. If the ulcer is healed during Phase #2 treatment, the patient discontinues from the study at that time. If the ulcer remains unhealed after 20 weeks of Phase #2, the study is stopped. Efficacy assessments include the time to complete healing of the ulcer, the incidence of complete ulcer healing, and the reduction in total ulcer area at the end of the study. Safety assessments include the incidence of adverse events throughout the study, changes in clinical laboratory tests (hematology, chemistry, urinalysis), measurement of vital signs at specified intervals, and physical examinations at the start and end of the study. The study hypothesis is that the time to complete healing of diabetic foot ulcers with continued treatment using REGRANEX® is shorter than the time to healing with placebo and that the patients will well tolerate the medication. REGRANEX® gel (or placebo) applied to cover the entire surface of the ulcer, once a day for up to 52 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of Type I or Type II diabetes mellitus and a glycohemoglobin A1c<12%
- Minimum of one neuropathic, diabetic ulcer meeting the following criteria: stage III or IV, located on the distal lower extremity, between 1 and 15 square centimeters
- No exposed bone at the ulcer site
- No osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure
- Adequate arterial circulation to the foot
Key exclusion criteria (8 listed)
- Hypersensitivity to REGRANEX® Gel or one of its components
- Presence of more than two full-thickness diabetic ulcers on either lower extremity
- presence of an active systemic or local cancer or tumor of any kind
- Use of topical antibiotics, antiseptics, enzymatic debriders, or any other agents on the selected ulcers, within the seven days preceding randomization
- Active rheumatic or collagen vascular disease or pre-existing conditions or diseases which may interfere with the evaluation of safety or efficacy of Regranex
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 |
|---|---|---|
| Becaplermin | Drug | – |
Primary outcome
Time to complete ulcer healing.
1 secondary outcome
Incidence of complete ulcer healing and reduction in total ulcer area at end of study. Incidence of adverse events throughout study.
Results and safety
The study was stopped early (reason given: Slow recruitment; Study did not address safety concern raised by European Medicines Agency). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or PlaceboLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Becaplermin in people with Foot Ulcer and Diabetic Foot, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 8 Jun 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Slow recruitment; Study did not address safety concern raised by European Medicines Agency). Results are not available in the source record.
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?
Time to complete ulcer healing.. 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 8 Jun 2011.