Wound HealNCT04223089
Accuracy of TCOM vs NIRS in Predicting Wound Outcomes in Patients Treated With or Without Revascularization
An observational study of Wound Heal, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Wound Heal
- What is being tested?
- Near Infrared Spectroscopy
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2019to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Missouri, 66160
About this study
Official title: Accuracy of Transcutaneous Oxygen Monitoring (TCOM) vs Near Infrared Spectroscopy (NIRS) in Predicting Wound Outcomes in Patients Treated With or Without Revascularization
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.
- Conditions
- Wound Heal
- Being tested
- Near Infrared Spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared SpectroscopyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Near Infrared Spectroscopy | |
| 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 Receives: Diagnostic Test: Near Infrared Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From presentation to wound healing or amputation (approximately 6 months at most)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start17 Dec 2019
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Alli, MD, Principal investigator, KUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223089
- Sponsor's protocol ID
- STUDY00144156
- Status last verified
- May 2023
- First submitted
- 7 Jan 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Transcutaneous Oxygen Monitoring (TCOM) vs Near Infrared Spectroscopy (NIRS) in Predicting Wound Outcomes in Patients Treated With or Without Revascularization
- ClinicalTrials.gov ID
- NCT04223089
- Acronym / sponsor ID
- STUDY00144156
- Conditions
- Wound Heal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revascularization | – | Diagnostic Test: Near Infrared SpectroscopyThis 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 | – | Diagnostic Test: Near Infrared SpectroscopyThis 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infrared SpectroscopyThe 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. | Diagnostic test | Medical Management, Revascularization |
Primary outcome
Accuracy of NIRS measurements
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Alli, MD principal investigator
KUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Heal, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of NIRS measurements (time frame: From presentation to wound healing or amputation (approximately 6 months at most)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.