Wound Heal
Conditions
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.
Interventions
DIAGNOSTIC_TESTNear Infrared Spectroscopy
The Kent Camera is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of the following in superficial tissue: * oxygen saturation (StO2), * relative oxyhemoglobin level (HbO2), and * relative deoxyhemoglobin (Hb) level The Kent Camera displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions. The Kent Camera is indicated for use to determine oxygenation levels in superficial tissues.
Sponsors
University of Kansas Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed