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Completed

NCT Number: NCT01235260

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

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.

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Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Diabetes Complications Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Neoplasms Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Becaplermin nonusers

Other

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)

Becaplermin users

Drug

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

Primary outcomes

  1. 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.

    Time frame: From time of recruitment beginning in October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.

  2. The number and rate of deaths from cancer in patients who have used becaplermin and patients who have not used not used becaplermin.

    Time frame: From time of accrual beginning in October 1, 1999 until the earliest of September 30, 2007 or death.

Secondary outcomes

  1. The number of becaplermin doses associated with risk of incident cancer and/or cancer death.

    Time frame: From the date of the first becaplermin dispensing beginning October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Industry

Collaborators

  • Bedford Research Corporation, Inc.

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 5, 2010
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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