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

Sponsor
Southwest Regional Wound Care Center (Other)
Overall Status
Completed
CT.gov ID
NCT00760357
Collaborator
(none)
190
1
12
15.8

Study Details

Study Description

Brief 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 osteomyelitis, type and amount of antibiotic administered, number of hyperbaric oxygen treatments, and if the wound healed.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    190 participants
    Time Perspective:
    Retrospective
    Official Title:
    A Retrospective Analysis of Patients With Full Thickness Wounds in Limbs With Critical Ischemia
    Study Start Date :
    Apr 1, 2007
    Actual Primary Completion Date :
    Apr 1, 2008
    Actual Study Completion Date :
    Apr 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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 [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southwest Regional Wound Care Center Lubbock Texas United States 79410

    Sponsors and Collaborators

    • Southwest Regional Wound Care Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Randall Wolcott, Principal Investigator, Southwest Regional Wound Care Center
    ClinicalTrials.gov Identifier:
    NCT00760357
    Other Study ID Numbers:
    • 56-RW-007
    First Posted:
    Sep 26, 2008
    Last Update Posted:
    Nov 26, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Randall Wolcott, Principal Investigator, Southwest Regional Wound Care Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 26, 2015