- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00740922
Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers
June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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].
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
563
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with chronic full thickness diabetic ulcers who were treated with becaplermin or placebo gel in two previous studies
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
|
Becaplermin gel 100 µg/g versus placebo gel (up to 12 applications).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
single visit 12 months after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
single visit 12 months after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1999
Study Completion (Actual)
April 1, 2001
Study Registration Dates
First Submitted
August 21, 2008
First Submitted That Met QC Criteria
August 22, 2008
First Posted (Estimate)
August 25, 2008
Study Record Updates
Last Update Posted (Estimate)
June 8, 2011
Last Update Submitted That Met QC Criteria
June 6, 2011
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Ulcer
- Diabetic Foot
- Physiological Effects of Drugs
- Angiogenesis Modulating Agents
- Growth Substances
- Anticoagulants
- Angiogenesis Inducing Agents
- Becaplermin
Other Study ID Numbers
- CR004156
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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