Critical Limb IschemiaNCT00760357
A Retrospective Analysis of Patients With Full Thickness Wounds in Limbs With Critical Ischemia
An observational study of Critical Limb Ischemia, run by Southwest Regional Wound Care Center at 1 site in United States.
Trial summary
Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated. The data that will be extracted from each chart will include patient's age, patient's gender, number of office visits, presence of diabetes, presence of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Limb Ischemia
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Apr 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated. The data that will be extracted from each chart will include patient's age, patient's gender, number of office visits, presence of diabetes, presence of osteomyelitis, type and amount of antibiotic administered, number of hyperbaric oxygen treatments, and if the wound healed.
Who may be able to join
- The inclusion criteria for the study are patients that demonstrate the following:
- A limb with a TCpO2 less than 20 with a full thickness wound.
- Initial visit from August 1, 2002 to December 31, 2005.
Who cannot join
- The exclusion criteria for the study are patients that demonstrate the following:
- Partial thickness wound or no wound in limb with critical ischemia.
- A medical record that does not clearly demonstrate critical limb ischemia or does not clearly demonstrates a full thickness wound.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest Regional Wound Care Center
Lubbock, Texas, 79410
About this study
Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated. The data that will be extracted from each chart will include patient's age, patient's gender, number of office visits, presence of diabetes, presence of osteomyelitis, type and amount of antibiotic administered, number of hyperbaric oxygen treatments, and if the wound healed.
Read the detailed description
Clinicians have even learned to group patients into different etiologic categories based on underlying disease such as diabetes mellitus, decubitus ulcer, surgical site infection, venous insufficiency, arterial insufficiency and others. It seems that wounds have been grouped into these categories because of their common barriers, which should allow us more precise algorithms and may provide better outcomes. That is diabetics tend to have the barriers of poor perfusion, endothelial cell dysfunction, white blood cell dysfunction, hyperglycemia, neuropathy and repetitive trauma. Venous insufficiency patients tend to have perivascular cuffing and peri wound edema. However patients with venous leg ulcers commonly have peripheral arterial disease and diabetes (3). The point is regardless of the etiology of the wound every patient must be evaluated for all barriers on every visit. Arbitrarily dividing chronic wounds in the etiologic categories has not significantly improved wound healing outcomes.
- Conditions
- Critical Limb Ischemia
- Keywords
- Critical Ischemia
- Medical subject headings
- Chronic Limb-Threatening Ischemia
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 |
|---|---|---|
| Retrospective Anaylsis | Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated
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 posted26 Sep 2008 (estimated)
- Study startApr 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- Time perspective
- Retrospective
- Enrolment
- 190 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 D Wolcott, MD, Principal investigator, Southwest Regional Wound Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760357
- Sponsor's protocol ID
- 56-RW-007
- Status last verified
- Nov 2015
- First submitted
- 24 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 in Limbs With Critical Ischemia
- ClinicalTrials.gov ID
- NCT00760357
- Acronym / sponsor ID
- 56-RW-007
- Conditions
- Critical Limb Ischemia
- Keywords
- Critical Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Southwest Regional Wound Care CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 26 Sep 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.
Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated. The data that will be extracted from each chart will include patient's age, patient's gender, number of office visits, presence of diabetes, presence of osteomyelitis, type and amount of antibiotic administered, number of hyperbaric oxygen treatments, and if the wound healed.
Detailed description
Clinicians have even learned to group patients into different etiologic categories based on underlying disease such as diabetes mellitus, decubitus ulcer, surgical site infection, venous insufficiency, arterial insufficiency and others. It seems that wounds have been grouped into these categories because of their common barriers, which should allow us more precise algorithms and may provide better outcomes. That is diabetics tend to have the barriers of poor perfusion, endothelial cell dysfunction, white blood cell dysfunction, hyperglycemia, neuropathy and repetitive trauma. Venous insufficiency patients tend to have perivascular cuffing and peri wound edema. However patients with venous leg ulcers commonly have peripheral arterial disease and diabetes (3). The point is regardless of the etiology of the wound every patient must be evaluated for all barriers on every visit. Arbitrarily dividing chronic wounds in the etiologic categories has not significantly improved wound healing outcomes.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective Anaylsis | – | –Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated. The data that will be extracted from each chart will include patient's age, patient's gender, number of office visits, presence of diabetes, presence of osteomyelitis, type and amount of antibiotic administered, number of hyperbaric oxygen treatments, and if the wound healed.
Key inclusion criteria (3 listed)
- The inclusion criteria for the study are patients that demonstrate the following:
Key exclusion criteria (3 listed)
- The exclusion criteria for the study are patients that demonstrate the following:
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
Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated
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 D Wolcott, MD principal investigator
Southwest Regional Wound Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Limb Ischemia, run by Southwest Regional Wound Care Center at 1 site in United States.
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 3 inclusion and 3 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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated (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.