WoundsNCT01089673
A Retrospective Study of the Effects of Molecular Diagnostics on Wound Care Outcomes
An observational study of Wounds, run by Southwest Regional Wound Care Center.
Trial summary
A retrospective molecular diagnostic review on wound care outcomes between two time periods. The time periods include June, July, August of 2008 and June, July, August of 2009. The retrospective review would analyze the days of healing during those two timeframes, upon the introduction of molecular diagnostic testing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wounds
- What is being tested?
- data collection
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Sep 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient records would be extracted from the electronic health record system of Southwest Regional Wound Care Center.
Who may be able to join
- A patient record captured during June, July, August 2008 and June, July, or August of 2009.
Who cannot join
- A patient record captured outside the time frame of June, July August 2008 or June, July, August of 2009.
About this study
A retrospective molecular diagnostic review on wound care outcomes between two time periods. The time periods include June, July, August of 2008 and June, July, August of 2009. The retrospective review would analyze the days of healing during those two timeframes, upon the introduction of molecular diagnostic testing.
- Conditions
- Wounds
- Being tested
- data collection
- Keywords
- retrospective data collection
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
retrospective data collection
| Study group | Role | What they receive |
|---|---|---|
| no treatment | retrospective data analysis Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
A retrospective molecular diagnostic review on wound care outcomes between two time periods.
The retrospective review would analyze the days of healing during those two timeframes, upon the introduction of molecular diagnostic testing.
Measured: The time periods include June, July, August of 2008 and June, July, August of 2009.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Regional Wound Care Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall Wolcott, Southwest Regional Wound Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089673
- Sponsor's protocol ID
- 56-RW-016
- Status last verified
- Sep 2011
- First submitted
- 17 Mar 2010
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of the Effects of Molecular Diagnostics on Wound Care Outcomes
- ClinicalTrials.gov ID
- NCT01089673
- Acronym / sponsor ID
- 56-RW-016
- Conditions
- Wounds
- Keywords
- retrospective data collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Southwest Regional Wound Care CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 18 Mar 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.
A retrospective molecular diagnostic review on wound care outcomes between two time periods. The time periods include June, July, August of 2008 and June, July, August of 2009. The retrospective review would analyze the days of healing during those two timeframes, upon the introduction of molecular diagnostic testing.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | Other: data collectionretrospective data analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient records would be extracted from the electronic health record system of Southwest Regional Wound Care Center.
Key inclusion criteria (1 listed)
- A patient record captured during June, July, August 2008 and June, July, or August of 2009.
Key exclusion criteria (1 listed)
- A patient record captured outside the time frame of June, July August 2008 or June, July, August of 2009.
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 |
|---|---|---|
| data collectionretrospective data collection | Other | no treatment |
Primary outcome
A retrospective molecular diagnostic review on wound care outcomes between two time periods.
Time frame: The time periods include June, July, August of 2008 and June, July, August of 2009.
The retrospective review would analyze the days of healing during those two timeframes, upon the introduction of molecular diagnostic testing.
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 7 Sep 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds, run by Southwest Regional Wound Care Center.
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 7 Sep 2011. 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?
A retrospective molecular diagnostic review on wound care outcomes between two time periods. (time frame: The time periods include June, July, August of 2008 and June, July, August of 2009.). 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 7 Sep 2011.