A Study of Cancer Risk Associated With Becaplermin Use in Veteran Diabetes Patients Served by the U.S. Veterans Health Administration
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.
Observational Model: Cohort, Time Perspective: Retrospective
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.
From time of recruitment beginning in October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Institutional Review Board