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 |
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Recruitment Status :
Completed
First Posted : August 25, 2008
Last Update Posted : June 8, 2011
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Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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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].
| Condition or disease | Intervention/treatment |
|---|---|
| Platelet-Derived Growth Factor Diabetic Foot Neoplasms | Drug: Sterile becaplermin gel vs. sterile placebo gel treatment 1 |
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 |
| 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 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Becaplermin
| 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). |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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
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)
Information from the National Library of Medicine
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
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
| 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.:
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Becaplermin gel Target Ulcer Retrospective Studies Diabetic Foot |
Neoplasms Long-Term Safety Topical Administration |
Additional relevant MeSH terms:
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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 |