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

NCT00740922 | Completed

• 1 other identifier: CR004156
• Study Type: observational
• Target: 563
• Locations: 0 countries
• Sites: N/A

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 of 2 double-blind trials \[neither the physician nor the patient knows the name of the study drug (PDGF-DBFT-003 and PDGF-DBFT-005\].

Conditions

Platelet-Derived Growth Factor; Diabetic Foot; Neoplasms

Keywords

Becaplermin gel; Target Ulcer; Retrospective Studies; Diabetic Foot; Neoplasms; Long-Term Safety; Topical Administration

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  single visit 12 months after enrollment

Study Arms (1)

1

Drug: Sterile becaplermin gel vs. sterile placebo gel treatment 1

Interventions

Sterile becaplermin gel vs. sterile placebo gel treatment 1 DRUG

Becaplermin gel 100 µg/g versus placebo gel (up to 12 applications).

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• Evaluation of the safety follow-up of becaplermin or placebo gel following treatment of chronic, full thickness diabetic ulcers.

MeSH Terms

Conditions

Diabetic Foot; Neoplasms

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: August 25, 2008
• Study Start: July 1, 1999
• Study Completion: April 1, 2001
• Last Updated: June 8, 2011

Record last verified: 2010-04