Accuracy of TCOM vs NIRS in Predicting Wound Outcomes in Patients Treated With or Without Revascularization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-17

Study Completion Date

2022-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Wound Heal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Near Infrared Spectroscopy

Intervention Type 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:

* 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

Near Infrared Spectroscopy

Intervention Type 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:

* 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No