Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers
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ClinicalTrials.gov Identifier: NCT00740922 |
Recruitment Status
:
Completed
First Posted
: August 25, 2008
Last Update Posted
: June 8, 2011
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Condition or disease | Intervention/treatment |
---|---|
Platelet-Derived Growth Factor Diabetic Foot Neoplasms | Drug: Sterile becaplermin gel vs. sterile placebo gel treatment 1 |
Study Type : | Observational |
Actual Enrollment : | 563 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | A Multicenter Clinical Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers |
Study Start Date : | July 1999 |
Actual Study Completion Date : | April 2001 |

Group/Cohort | Intervention/treatment |
---|---|
1 |
Drug: Sterile becaplermin gel vs. sterile placebo gel treatment 1
Becaplermin gel 100 µg/g versus placebo gel (up to 12 applications).
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- 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 ]
- 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 ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740922
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Additional Information:
Responsible Party: | Clinical Leader, Internal Medicine, EP, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00740922 History of Changes |
Other Study ID Numbers: |
CR004156 |
First Posted: | August 25, 2008 Key Record Dates |
Last Update Posted: | June 8, 2011 |
Last Verified: | April 2010 |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Becaplermin gel Target Ulcer Retrospective Studies Diabetic Foot |
Neoplasms Long-Term Safety Topical Administration |
Additional relevant MeSH terms:
Diabetic Foot Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Foot Ulcer Leg Ulcer Skin Ulcer Skin Diseases Diabetes Complications |
Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies Becaplermin Angiogenesis Inducing Agents Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs |