NCT01235260

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

A Study of Cancer Risk Associated With Becaplermin Use in Veteran Diabetes Patients Served by the U.S. Veterans Health Administration

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: —
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Foot Ulcer
• Diabetic Foot
• Diabetic Neuropathies

Interventions

Type	Name	Description
OTHER	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)
DRUG	Becaplermin users	A cohort of becaplermin users (ie, patients with diabetes treated with becaplermin)

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2010-11-05
• Last updated: 2016-07-19