Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts 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)

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Diagnostic Test: Near 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.
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
  • Diagnostic Test: Near 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.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Missouri 66160
Contact:
Carissa Walter, MPH
913-945-7450
cwalter2@kumc.edu

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Carissa Walter, MPH
913-945-7450
cwalter2@kumc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.