Platelet-Derived Growth FactorNCT00740922
Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers
An observational study of Platelet-Derived Growth Factor and Diabetic Foot, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to retrospectively evaluate the safety of sterile becaplermin gel compared with sterile placebo gel treatment 12 months or more after the last dose was administered in 1 of 2 double-blind trials [neither the physician nor the patient knows the name of the study drug (PDGF-DBFT-003 and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Platelet-Derived Growth Factor, Diabetic Foot, Neoplasms
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 563 participants
- Where
- No sites listed yet
- Study dates
- Jul 1999to Apr 2001
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic full thickness diabetic ulcers who were treated with becaplermin or placebo gel in two previous studies
Who may be able to join
- Patients are required to satisfy the following criteria before entering the study: given written informed consent before the performance of any study-related procedures, if deceased, the cause of death, if known, is collected by the investigator (where permitted by the local authorities)
- Received at least 1 dose of study medication in 1 of the double-blind trials PDGF-DBFT-003 or PDGF-DBFT-005 and had any post-baseline data
- A minimum of 12 months elapsed since last study drug dosing in 1 of the double-blind trials PDGF-DBFT-003 or PDGF-DBFT-005
Who cannot join
- Patients who meet any of the following criteria are excluded from participating in the study: Patients who are unwilling to participate
- Patients who, despite multiple and documented efforts, could not be contacted (the investigator was asked to try at least 3 times to contact the patient or patient's representative or parents by mail and phone)
About this study
Official title: A Multicenter Clinical Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers
The purpose of this study is to retrospectively evaluate the safety of sterile becaplermin gel compared with sterile placebo gel treatment 12 months or more after the last dose was administered in 1 of 2 double-blind trials [neither the physician nor the patient knows the name of the study drug (PDGF-DBFT-003 and PDGF-DBFT-005].
Read the detailed description
This single-visit, retrospective study was designed to evaluate the long-term safety of becaplermin gel 100 mcg/g versus placebo gel. Patients previously enrolled in protocol PDGF-DBFT-003 or PDGF-DBFT-005 were evaluated during a single-study visit in which retrospective safety data were collected. Recurrence data on the Target Ulcer were also obtained. The maximum number of patients in this study was the sum of patients enrolled in the 2 previous trials. The investigators made every effort to contact all patients enrolled in the previous double-blind trials in order to get follow-up information on as many patients as possible. If the patient was deceased, the cause of death, if known, was collected by the investigator (where permitted by the local authorities). After evaluation of the entrance criteria, demographic data, significant new intercurrent illnesses, a current medication profile, therapies received for the treatment of any diabetic neuropathic foot ulcer and surgeries in the last 12 or more months were collected and recorded. A questionnaire was used by the investigational staff to elicit patient information. At the visit, a complete physical examination was done (special attention was given to assess the presence of any malignancies), the feet were carefully examined and the footwear was assessed. The site of the Target Ulcer treated in the previous double-blind trial was assessed by an independent dermatologist.and photographs of the heel, back, inside and outside surfaces of the foot, as well as a distance photograph of the foot, were taken. Parameters such as major changes in the general health, (i.e., hospitalizations, major illnesses, and past surgeries), and past as well as present histories of any malignant diseases were carefully assessed. Of primary interest were the examination of previously treated ulcer site(s) and the Target Ulcer limb in general, for recurrences and/or new ulcerations; their treatments and outcomes; and any other relevant changes to the previously treated ulcer and the surrounding skin. Observational study - No study drug administered
- Conditions
- Platelet-Derived Growth Factor, Diabetic Foot, Neoplasms
- Being tested
- Sterile becaplermin gel vs. sterile placebo gel treatment 1
- Keywords
- Becaplermin gel, Target Ulcer, Retrospective Studies, Diabetic Foot, Neoplasms, Long-Term Safety, Topical Administration
- Medical subject headings
- Diabetic Foot, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile becaplermin gel vs. sterile placebo gel treatment 1Drug
Becaplermin gel 100 µg/g versus placebo gel (up to 12 applications).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Drug: Sterile becaplermin gel vs. sterile placebo gel treatment 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to retrospectively evaluate the safety of sterile becaplermin gel vs. sterile placebo gel treatment 12 months or more after the last dose was administered.
Measured: single visit 12 months after enrollment
Secondary outcomes (1)
The secondary objective of the trial was to evaluate recurrence of the Target Ulcer if it had healed in the previous trial.
Measured: single visit 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startJul 1999
- Study completionApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-Derived Growth FactorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 563 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
- NCT00740922
- Sponsor's protocol ID
- CR004156
- Status last verified
- Apr 2010
- First submitted
- 21 Aug 2008
- Last updated
- 8 Jun 2011
- Results posted
- 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 Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers
- ClinicalTrials.gov ID
- NCT00740922
- Acronym / sponsor ID
- CR004156
- Conditions
- Platelet-Derived Growth Factor, Diabetic Foot, Neoplasms
- Keywords
- Becaplermin gel, Target Ulcer, Retrospective Studies, Diabetic Foot, Neoplasms, Long-Term Safety, Topical Administration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jul 1999
- Study completion
- Apr 2001 (actual)
- First posted
- 25 Aug 2008 (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 retrospectively evaluate the safety of sterile becaplermin gel compared with sterile placebo gel treatment 12 months or more after the last dose was administered in 1 of 2 double-blind trials [neither the physician nor the patient knows the name of the study drug (PDGF-DBFT-003 and PDGF-DBFT-005].
Detailed description
This single-visit, retrospective study was designed to evaluate the long-term safety of becaplermin gel 100 mcg/g versus placebo gel. Patients previously enrolled in protocol PDGF-DBFT-003 or PDGF-DBFT-005 were evaluated during a single-study visit in which retrospective safety data were collected. Recurrence data on the Target Ulcer were also obtained. The maximum number of patients in this study was the sum of patients enrolled in the 2 previous trials. The investigators made every effort to contact all patients enrolled in the previous double-blind trials in order to get follow-up information on as many patients as possible. If the patient was deceased, the cause of death, if known, was collected by the investigator (where permitted by the local authorities). After evaluation of the entrance criteria, demographic data, significant new intercurrent illnesses, a current medication profile, therapies received for the treatment of any diabetic neuropathic foot ulcer and surgeries in the last 12 or more months were collected and recorded. A questionnaire was used by the investigational staff to elicit patient information. At the visit, a complete physical examination was done (special attention was given to assess the presence of any malignancies), the feet were carefully examined and the footwear was assessed. The site of the Target Ulcer treated in the previous double-blind trial was assessed by an independent dermatologist.and photographs of the heel, back, inside and outside surfaces of the foot, as well as a distance photograph of the foot, were taken. Parameters such as major changes in the general health, (i.e., hospitalizations, major illnesses, and past surgeries), and past as well as present histories of any malignant diseases were carefully assessed. Of primary interest were the examination of previously treated ulcer site(s) and the Target Ulcer limb in general, for recurrences and/or new ulcerations; their treatments and outcomes; and any other relevant changes to the previously treated ulcer and the surrounding skin. Observational study - No study drug administered
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Sterile becaplermin gel vs. sterile placebo gel treatment 1 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic full thickness diabetic ulcers who were treated with becaplermin or placebo gel in two previous studies
Key inclusion criteria (3 listed)
- Patients are required to satisfy the following criteria before entering the study: given written informed consent before the performance of any study-related procedures, if deceased, the cause of death, if known, is collected by the investigator (where permitted by the local authorities)
- Received at least 1 dose of study medication in 1 of the double-blind trials PDGF-DBFT-003 or PDGF-DBFT-005 and had any post-baseline data
- A minimum of 12 months elapsed since last study drug dosing in 1 of the double-blind trials PDGF-DBFT-003 or PDGF-DBFT-005
Key exclusion criteria (2 listed)
- Patients who meet any of the following criteria are excluded from participating in the study: Patients who are unwilling to participate
- Patients who, despite multiple and documented efforts, could not be contacted (the investigator was asked to try at least 3 times to contact the patient or patient's representative or parents by mail and phone)
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 |
|---|---|---|
| Sterile becaplermin gel vs. sterile placebo gel treatment 1Becaplermin gel 100 µg/g versus placebo gel (up to 12 applications). | Drug | 1 |
Primary outcome
The primary objective of this study is to retrospectively evaluate the safety of sterile becaplermin gel vs. sterile placebo gel treatment 12 months or more after the last dose was administered.
Time frame: single visit 12 months after enrollment
1 secondary outcome
The secondary objective of the trial was to evaluate recurrence of the Target Ulcer if it had healed in the previous trial.
Time frame: single visit 12 months after enrollment
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 8 Jun 2011.
- Evaluation of the safety follow-up of becaplermin or placebo gel following treatment of chronic, full thickness diabetic ulcers.Link 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?
An observational study of Platelet-Derived Growth Factor 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 3 inclusion and 2 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 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.
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?
The primary objective of this study is to retrospectively evaluate the safety of sterile becaplermin gel vs. sterile placebo gel treatment 12 months or more after the last dose was administered. (time frame: single visit 12 months after enrollment). 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.