Full Thickness WoundsNCT00764088
A Retrospective Analysis of Patients With Full Thickness Wounds on a Case by Case Basis
An observational study of Full Thickness Wounds, run by Southwest Regional Wound Care Center.
Trial summary
To demonstrate the effectiveness or ineffectiveness of novel treating agents or agents used for compassionate rescue, subjects and their wounds will be analyzed retrospectively and their non-identifiable information will be compiled in the form of case studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Full Thickness Wounds
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jun 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic- Southwest Regional Wound Care Center
Who may be able to join
- Male or female > 18 years old
- Retrospective analysis
Who cannot join
None listed.
About this study
To demonstrate the effectiveness or ineffectiveness of novel treating agents or agents used for compassionate rescue, subjects and their wounds will be analyzed retrospectively and their non-identifiable information will be compiled in the form of case studies. Subjects who demonstrated characteristics of interest (e.g. healing) as determined by the PI will be chosen for case studies.
Read the detailed description
All wounds at the Southwest Regional Wound Care Center (WCC) are managed using anti-biofilm strategies. When determining the therapeutic course for a patient and his full thickness wound, all management agents that are available are considered for use; and the clinician uses his judgment to determine the most appropriate tools to use that will give the patient the most likely chance of success. Some of the agents that are used are novel, and it is appropriate to demonstrate to others the potential usefulness of these agents
- Conditions
- Full Thickness Wounds
- Keywords
- full Thickness wounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anaysis of Full Thickness wounds | To demonstrate the effectiveness or ineffectiveness of novel treating agents or agents used for compassionate rescue, subjects and their wounds will be analyzed retrospectively and their non-identifiable information will be compiled in the form of case studies. Subjects who demonstrated characteristics of interest (e.g. healing) as determined by the PI will be chosen for case studies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective Analysis of Patients with Full Thickness Wounds
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startAug 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Thickness 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-control
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
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
- Investigators
- Randall Wolcott, MD, Principal investigator, Southwest Regional Wound Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764088
- Sponsor's protocol ID
- 56-RW-008
- Status last verified
- Nov 2015
- First submitted
- 29 Sep 2008
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Patients With Full Thickness Wounds on a Case by Case Basis
- ClinicalTrials.gov ID
- NCT00764088
- Acronym / sponsor ID
- 56-RW-008
- Conditions
- Full Thickness Wounds
- Keywords
- full Thickness wounds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Southwest Regional Wound Care CenterUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 1 Oct 2008 (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.
To demonstrate the effectiveness or ineffectiveness of novel treating agents or agents used for compassionate rescue, subjects and their wounds will be analyzed retrospectively and their non-identifiable information will be compiled in the form of case studies. Subjects who demonstrated characteristics of interest (e.g. healing) as determined by the PI will be chosen for case studies.
Detailed description
All wounds at the Southwest Regional Wound Care Center (WCC) are managed using anti-biofilm strategies. When determining the therapeutic course for a patient and his full thickness wound, all management agents that are available are considered for use; and the clinician uses his judgment to determine the most appropriate tools to use that will give the patient the most likely chance of success. Some of the agents that are used are novel, and it is appropriate to demonstrate to others the potential usefulness of these agents
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anaysis of Full Thickness wounds | – | –To demonstrate the effectiveness or ineffectiveness of novel treating agents or agents used for compassionate rescue, subjects and their wounds will be analyzed retrospectively and their non-identifiable information will be compiled in the form of case studies. Subjects who demonstrated characteristics of interest (e.g. healing) as determined by the PI will be chosen for case studies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic- Southwest Regional Wound Care Center
Key inclusion criteria (2 listed)
- Male or female > 18 years old
- Retrospective analysis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective Analysis of Patients with Full Thickness Wounds
Time frame: 1 year
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 26 Nov 2015.
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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.
Randall Wolcott, MD principal investigator
Southwest Regional Wound Care Center
Questions about this trial
What is this clinical trial studying?
An observational study of Full Thickness 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 2 inclusion and 0 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 26 Nov 2015. 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?
Retrospective Analysis of Patients with Full Thickness Wounds (time frame: 1 year). 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 26 Nov 2015.