Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers

• Status: Completed
• Trial end date: 2001-04-01
• Target enrollment: 0
• Participant gender: All

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 PDGF-DBFT-005].

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Becaplermin; Platelet-derived growth factor BB

Criteria

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)