Clinical trial · Observational
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
NCT01235260CI-TRIAL-00023140completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes Mellitus | — | UNRESOLVED | — |
| Diabetic Foot | — | UNRESOLVED | — |
| Diabetic Neuropathies | — | UNRESOLVED | — |
| Foot Ulcer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Becaplermin nonusers | Other | — | UNRESOLVED |
| Becaplermin users | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 001
- description
- Becaplermin users A cohort of becaplermin users (ie patients with diabetes treated with becaplermin)
- interventionNames
- Drug: Becaplermin users
- label
- 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)
- interventionNames
- Other: Becaplermin nonusers
Primary outcomes (2)
- measure
- 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.
- timeFrame
- From time of recruitment beginning in October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.