Expired Study
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Lubbock, Texas 79410


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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.


Study is Available At:


Original ID:

56-RW-007


NCT ID:

NCT00760357


Secondary ID:


Study Acronym:


Brief Title:

A Retrospective Analysis of Patients With Full Thickness Wounds in Limbs With Critical Ischemia


Official Title:

A Retrospective Analysis of Patients With Full Thickness Wounds in Limbs With Critical Ischemia


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Southwest Regional Wound Care Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Time Perspective: Retrospective


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

190


Enrollment Type:

Actual


Overall Contact Information

Official Name:Randall D Wolcott, MD
Principal Investigator
Southwest Regional Wound Care Center

Study Dates

Start Date:April 2007
Completion Date:April 2008
Completion Type:Actual
Primary Completion Date:April 2008
Primary Completion Type:Actual
Verification Date:November 2015
Last Changed Date:November 24, 2015
First Received Date:September 24, 2008

Study Outcomes

Outcome Type: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
Safety Issues:True

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Retrospective Anaylsis
Description: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Southwest Regional Wound Care Center

Samples and Retentions

Sample Retention:Samples With DNA
Description: 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.
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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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