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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

Page last updated: August 23, 2015

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