Diabetes MellitusNCT01235260
Becaplermin Use and Cancer Risk in a Patient Population of U.S. Veterans With Diabetes
An observational study of Diabetes Mellitus and Foot Ulcer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Diabetes Mellitus, Foot Ulcer, Diabetic Foot
- What is being tested?
- Becaplermin nonusers and Becaplermin users
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diabetic foot ulcers who are members of the U.S. Department of Veterans Affairs Health Care System (VA)
Who may be able to join
- Patients with diabetic foot ulcers who are members of the U.S Department of Veterans Affairs Health Care System (VA)
Who cannot join
- History of cancer (including nonmelanoma skin cancer) prior to study entry
About this study
Official title: A Study of Cancer Risk Associated With Becaplermin Use in Veteran Diabetes Patients Served by the U.S. Veterans Health Administration
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.
Read the 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
- Being tested
- Becaplermin nonusers, Becaplermin users
- Keywords
- REGRANEX (becaplermin), Platelet-derived growth factor BB, Cancer, Cancer incidence, Cancer mortality, Lower Extremity Diabetic Neuropathic Ulcer
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer, Diabetic Foot, Diabetic Neuropathies, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becaplermin nonusersOther
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 usersDrug
A cohort of becaplermin users (ie, patients with diabetes treated with becaplermin)
| Study group | Role | What they receive |
|---|---|---|
| 001 | Becaplermin users A cohort of becaplermin users (ie patients with diabetes treated with becaplermin) Receives: Drug: Becaplermin users | |
| 002 | 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) Receives: Other: Becaplermin nonusers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From the date of the first becaplermin dispensing beginning October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bedford Research Corporation, Inc.
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235260
- Sponsor's protocol ID
- CR017497
- Other IDs
- REGRANEX-EPI-02
- Status last verified
- Jul 2016
- First submitted
- 4 Nov 2010
- Last updated
- 19 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Cancer Risk Associated With Becaplermin Use in Veteran Diabetes Patients Served by the U.S. Veterans Health Administration
- ClinicalTrials.gov ID
- NCT01235260
- Acronym / sponsor ID
- CR017497
- Conditions
- Diabetes Mellitus, Foot Ulcer, Diabetic Foot, Diabetic Neuropathies
- Keywords
- REGRANEX (becaplermin), Platelet-derived growth factor BB, Cancer, Cancer incidence, Cancer mortality, Lower Extremity Diabetic Neuropathic Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Bedford Research Corporation, Inc.
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 5 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: Becaplermin usersBecaplermin users A cohort of becaplermin users (ie patients with diabetes treated with becaplermin) |
| 002 | – | Other: Becaplermin nonusersBecaplermin 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) |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diabetic foot ulcers who are members of the U.S. Department of Veterans Affairs Health Care System (VA)
Key inclusion criteria (1 listed)
- Patients with diabetic foot ulcers who are members of the U.S Department of Veterans Affairs Health Care System (VA)
Key exclusion criteria (1 listed)
- History of cancer (including nonmelanoma skin cancer) prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Becaplermin nonusersA cohort of becaplermin nonusers (ie, patients who are not treated with becaplermin but are similar in characteristics to patients in the becaplermin user cohort) | Other | 002 |
| Becaplermin usersA cohort of becaplermin users (ie, patients with diabetes treated with becaplermin) | Drug | 001 |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Foot Ulcer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: From time of recruitment beginning in October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.