Accuracy of TCOM vs NIRS in Predicting Wound Outcomes in Patients Treated With or Without Revascularization
- Conditions
- Wound Heal
- Registration Number
- NCT04223089
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
The primary purpose of this project is to compare the accuracy of transcutaneous oxygen monitoring and near infrared spectroscopy in assessing cutaneous oxygen levels in chronic wounds of patients following revascularization procedures as well as those with conservatively managed chronic wounds. This study will also compare the efficiency and practicality of both methods in guiding treatment decisions and management of these wounds.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- Are between the ages of 18-85
- Presented with a non-healing lower extremity wound and have a Wagner classification for wound healing of grade 1 or 2
- Wagner grade 3-5
- Congestive heart failure (CHF) with a left ventrical ejection fraction (LVEF) < 30%
- Have had a below the knee drug eluting stent placed (paclitaxel is chemo, can make wounds worse)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accuracy of NIRS measurements From presentation to wound healing or amputation (approximately 6 months at most) To determine the accuracy of near infrared spectroscopy when compared to transcutaneous oxygen monitoring in assessing cutaneous oxygen levels and guiding treatment in patients with revascularized tissues or conservatively managed chronic wounds.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Missouri, United States
University of Kansas Medical Center🇺🇸Kansas City, Missouri, United States