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

NCT ID: NCT00760357

Last Updated: 2015-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-04-30

Brief Summary

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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

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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

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Critical Limb Ischemia

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southwest Regional Wound Care Center

OTHER

Sponsor Role lead

Responsible Party

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Randall Wolcott

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randall D Wolcott, MD

Role: PRINCIPAL_INVESTIGATOR

Southwest Regional Wound Care Center

Locations

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Southwest Regional Wound Care Center

Lubbock, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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56-RW-007

Identifier Type: -

Identifier Source: org_study_id