Clinical trial NCT01235260: Becaplermin Use and Cancer Risk in a Patient Population of U.S. Veterans With Diabetes
Official title: A Study of Cancer Risk Associated With Becaplermin Use in Veteran Diabetes Patients Served by the U.S. Veterans Health Administration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Foot Ulcer
Diabetic Foot
Diabetic Neuropathies
Keywords: REGRANEX (becaplermin)
Platelet-derived growth factor BB
Cancer
Cancer incidence
Cancer mortality
Lower Extremity Diabetic Neuropathic Ulcer
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: Bedford Research Corporation, Inc.
First posted: 2010-11-05
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diabetic foot ulcers who are members of the U.S. Department of Veterans Affairs Health Care System (VA)

Brief 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.

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 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

Primary outcomes:
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.
timeFrame: From time of recruitment beginning in October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.
measure: The number and rate of deaths from cancer in patients who have used becaplermin and patients who have not used not used becaplermin.
timeFrame: From time of accrual beginning in October 1, 1999 until the earliest of September 30, 2007 or death.
Secondary outcomes:
measure: The number of becaplermin doses associated with risk of incident cancer and/or cancer death.
timeFrame: From the date of the first becaplermin dispensing beginning October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: