Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-31 @ 8:32 AM
Study NCT ID:
NCT00760357
Status:
COMPLETED
Last Update Posted:
2015-11-26
First Post:
2008-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Analysis of Patients With Full Thickness Wounds in Limbs With Critical Ischemia
Sponsor:
Southwest Regional Wound Care Center
Organization:
Study Overview
Official Title:
A Retrospective Analysis of Patients With Full Thickness Wounds in Limbs With Critical Ischemia
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: