Becaplermin Use and Cancer Risk in a Patient Population of U.S. Veterans With Diabetes
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus; Foot Ulcer; Diabetic Foot; Diabetic Neuropathies
Intervention: Becaplermin nonusers (Other); Becaplermin users (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Summary
The purpose of this study is to evaluate risk of cancer incidence and mortality associated
with the use of REGRANEX (becaplermin) in patients with diabetes who are members of a U. S.
Veterans Health Administration.
Clinical Details
Official title: A Study of Cancer Risk Associated With Becaplermin Use in Veteran Diabetes Patients Served by the U.S. Veterans Health Administration
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: The number and rate of cases of incident cancers (grouped as non melanoma skin cancer, all other invasive cancers combined, and site specific cancers) in patients who have used becaplermin and patients who have not used becaplermin.The number and rate of deaths from cancer in patients who have used becaplermin and patients who have not used not used becaplermin.
Secondary outcome: The number of becaplermin doses associated with risk of incident cancer and/or cancer death.
Detailed description:
This is an observational study of patients with diabetes who are eligible for care through
the national Department of Veterans Affairs Health Care System (VA), representing the
largest sample of older adults in an integrated health care system in the U. S. with
comprehensive electronic medical records and linkable health survey data. REGRANEX
(becaplermin) is topical medication used to treat lower extremity diabetic neuropathic
ulcers. VA patients with diabetic foot ulcers who have no prior history of cancer who have
received treatment with becaplermin will be compared to a group of similar patients who have
not received treatment with becaplermin. Becaplermin users (from the time of initial
dispensing of becaplermin) and becaplermin nonusers will be followed forward in time for up
to 8 years to identify new cancers and cancer related deaths, with confirmation of cases
through registries and medical chart review. This is an observational study; no
investigational drug will be administered.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with diabetic foot ulcers who are members of the U. S Department of Veterans
Affairs Health Care System (VA)
Exclusion Criteria:
- History of cancer (including nonmelanoma skin cancer) prior to study entry
Locations and Contacts
Additional Information
Last updated: February 18, 2013
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