A Study of Cancer Risk Associated With Becaplermin Use in Veteran Diabetes Patients Served by the U.S. Veterans Health Administration
N/A
N/A
Both
Diabetes Mellitus, Foot Ulcer, Diabetic Foot, Diabetic Neuropathies
Trial Information
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
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.
Outcome Time Frame:
From time of recruitment beginning in October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.
Safety Issue:
Yes
Principal Investigator
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Authority:
United States: Institutional Review Board
Study ID:
CR017497
NCT ID:
NCT01235260
Start Date:
Completion Date:
Related Keywords:
- Diabetes Mellitus
- Foot Ulcer
- Diabetic Foot
- Diabetic Neuropathies
- REGRANEX (becaplermin)
- Platelet-derived growth factor BB
- Cancer
- Cancer incidence
- Cancer mortality
- Lower Extremity Diabetic Neuropathic Ulcer
- Diabetes Mellitus
- Diabetic Neuropathies
- Ulcer
- Foot Ulcer
- Diabetic Foot
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