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OpenTrials
Completed

NCT Number: NCT00760357

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Southwest Regional Wound Care Center

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 26, 2008
Registry last updated
Nov 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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