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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Randall Wolcott, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier:
NCT00760357
First received: September 24, 2008
Last updated: September 6, 2011
Last verified: September 2011
  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.


Condition
Critical Ischemia

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Retrospective Analysis of Patients With Full Thickness Wounds in Limbs With Critical Ischemia

Further study details as provided by Southwest Regional Wound Care Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

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.


Estimated Enrollment: 0
Study Start Date: April 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760357

Locations
United States, Texas
Southwest Regional Wound Care Center
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Southwest Regional Wound Care Center
  More Information

No publications provided

Responsible Party: Randall Wolcott, Principal Investigator, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier: NCT00760357     History of Changes
Other Study ID Numbers: 56-RW-007
Study First Received: September 24, 2008
Last Updated: September 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Southwest Regional Wound Care Center:
Critical Ischemia

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014