Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revascularization | This group will include patients whose cutaneous oxygen partial pressure (PO2) around the wound of interest measures less than 40 mmHg and therefore require revascularization. |
| |
| Medical Management | This group will include patients whose cutaneous PO2 around the wound of interest measures greater than 40 mmHg and will be managed conservatively in wound clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near Infrared Spectroscopy | Diagnostic Test | 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of NIRS measurements | 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. | From presentation to wound healing or amputation (approximately 6 months at most) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
This prospective study will include up to 200 adult patients who present with non-healing lower extremity wounds to the University of Kansas Medical Center. Patients will be grouped into two study arms depending on the degree of tissue ischemia (above or below 40 mmHg) and required treatment (conservative wound care alone or revascularization). Relevant clinical information will be obtained from patients' medical records including demographics, clinical history, intervention details, surgical records, and imaging data. Wound healing will be assessed at presentation, at the time of revascularization (pre and post-operative), and every 6 weeks thereafter by clinical assessment, Wagner classification, TCOM PO2 measurements and NIRS PO2 measurements. TCOM will guide treatment decisions and management, which is the current standard of care.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adam Alli, MD | KUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Missouri | 66160 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |