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

Critical Limb Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760357
• Other study ID #: 56-RW-007
• Status: Completed
• Phase: N/A
• First received: September 24, 2008
• Last updated: November 24, 2015
• Start date: April 2007
• Est. completion date: April 2008

Study information

• Verified date: November 2015
• Source: Southwest Regional Wound Care Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Locations

Country	Name	City	State
United States	Southwest Regional Wound Care Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Regional Wound Care Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes