Becaplermin Use and Cancer Risk in a Patient Population of U.S. Veterans With Diabetes

Johnson & Johnson (J&J)

Status: Completed

Conditions: Diabetic Foot; Foot Ulcer; Diabetes Mellitus; Diabetic Neuropathies

Treatments: Other: Becaplermin nonusers; Drug: Becaplermin users

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01235260

REGRANEX-EPI-02 (Other Identifier)

CR017497

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: Under 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

001

Description:

Becaplermin users A cohort of becaplermin users (ie patients with diabetes treated with becaplermin)

Treatment:

Drug: Becaplermin users

002

Description:

Becaplermin nonusers A cohort of becaplermin nonusers (ie patients who are not treated with becaplermin but are similar in characteristics to patients in the becaplermin user cohort)

Treatment:

Other: Becaplermin nonusers