Status:
COMPLETED
Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Platelet-Derived Growth Factor
Diabetic Foot
Eligibility:
All Genders
Brief 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 o...
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-DBF...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 1999
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2001
Estimated Enrollment :
563 Patients enrolled
Trial Details
Trial ID
NCT00740922
Start Date
July 1 1999
End Date
April 1 2001
Last Update
June 8 2011
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