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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01235260

Enrollment

Unknown

Registered

2010-11-05

Start date

2010-03-31

Completion date

2011-03-31

Last updated

2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Diabetic Foot, Diabetic Neuropathies, Foot Ulcer

Keywords

REGRANEX (becaplermin), Platelet-derived growth factor BB, Cancer, Cancer incidence, Cancer mortality, Lower Extremity Diabetic Neuropathic Ulcer

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.

Interventions

OTHERBecaplermin 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)

DRUGBecaplermin users

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 99 Years

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

Design outcomes

Primary

Measure	Time frame
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.	From time of recruitment beginning in October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.
The number and rate of deaths from cancer in patients who have used becaplermin and patients who have not used not used becaplermin.	From time of accrual beginning in October 1, 1999 until the earliest of September 30, 2007 or death.

Secondary

Measure	Time frame
The number of becaplermin doses associated with risk of incident cancer and/or cancer death.	From the date of the first becaplermin dispensing beginning October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026