Critical Limb IschemiaNCT05455554
The Use of FlowMet-R Technology to Predict Wound Healing in CLI Patients in a Wound Care Center Setting
An observational study of Critical Limb Ischemia, run by Stanford University at 1 site in United States.
Trial summary
Single-institution, prospective nonrandomized pilot study of critical limb ischemia patients with planned lower extremity revascularization will undergo Flowmet-D measurements in a wound care center setting to determine threshold values associated with wound healing and amputation. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Flowmet-D and ABI
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2022to 1 Sep 2023
- How long will I take part?
- 6 Months
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The CLI population is individuals with CLTI, at least one active lower extremity wound and planned lower extremity revascularization. The HBO cohort is a subset of the CLI population who will undergo HBO therapy post-revascularization.
Who may be able to join
- CLI Cohort:
- CLI by WIfI criteria (ABI or toe pressures)
- Non-healing lower extremity wound
- Planned lower extremity revascularization
- Able to provide informed consent
- Able to comply with study procedures
Show all 9Show fewer
- HBO Cohort:
- All of the above
- Enrolled in HBO therapy post revascularization (at the discretion of the provider)
Who cannot join
- Under 30
- Wound not suitable for FlowMet-D probe attachment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of FlowMet-R Technology to Predict Wound Healing in Critical Limb Ischemia (CLI) Patients in a Wound Care Center Setting
Single-institution, prospective nonrandomized pilot study of critical limb ischemia patients with planned lower extremity revascularization will undergo Flowmet-D measurements in a wound care center setting to determine threshold values associated with wound healing and amputation. A subset of patients will undergo hyperbaric oxygen therapy and will have Flowmet-D measurements to determine those who respond best to therapy.
Read the detailed description
A single-institution, prospective nonrandomized pilot study will be conducted at Stanford Hospital and the Stanford Advanced Wound Care Center (AWCC). Patients with CLTI by WIfI criteria (ABI or toe pressures) and a concomitant non-healing lower extremity wound will be recruited. Inclusion criteria will include CLTI, at least one active lower extremity wound and planned lower extremity revascularization. ABI/TBIs will be recorded preintervention, post intervention and at one and three month intervals. Intraprocedural characteristics including the number and location of vessels revascularized, patent runoff vessels pre and post procedure, pedal arch anatomy and presence of angiographic "blush" to wound will be documented.
Post-operatively, patients will be followed at the AWCC where they will receive standard of care wound management including offloading, regular debridement, infection and edema management. FlowMet-R perfusion values will be obtained prerevascularization, immediately post revascularization as well as weekly at each follow up AWCC visit for a total of up to 6 months or until wound healing.Wound size will be recorded.
Patients who undergo hyperbaric oxygen therapy (at the discretion of AWCC surgeon) will have perfusion values performed before and after hyperbaric oxygen therapy sessions 1, 2, 10, 20, 30 and 40. Hyperbaric oxygen therapy will be conducted 5 days a week for duration of 90 minutes. Patients who undergo other advanced wound care treatments such as stem cell therapies or skin substitutes will also received FlowMet-R prior to and after treatment. Primary outcomes will be wound healing defined as complete skin epithelialization, wound improvement rate, major and minor amputations as well as need for repeat revascularization.
- Conditions
- Critical Limb Ischemia
- Being tested
- Flowmet-D, ABI
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flowmet-DDiagnostic test
Flowmet-D is a non-invasive device that measures blood flow.
ABIDiagnostic test
ABI is the ratio of the systolic blood pressure measured at the ankle to that measured at the brachial artery and is considered the gold standard for the diagnosis of peripheral artery disease.
| Study group | Role | What they receive |
|---|---|---|
| CLI (Critical Limb Ischemia) | CLI cohort is a population of individuals with CLI, at least one active lower extremity wound and planned lower extremity revascularization. CLI cohort patients will receive Flowmet-D measurements in addition to standard of care therapy following intervention. Receives: Diagnostic Test: Flowmet-D; Diagnostic Test: ABI | |
| HBO (Hyperbaric Oxygen) | HBO cohort is a subset of the CLI cohort who will undergo hyperbaric oxygen therapy in the post-operative setting who will receive Flowmet-D measurements before and after their therapy. Receives: Diagnostic Test: Flowmet-D; Diagnostic Test: ABI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
Wound Healing, defined as complete skin epithelialization, will be associated with Flowmet-D measurements.
Measured: 6 months
Wound Improvement
Wound Improvement, defined as improvement in wound size, will be associated with Flowmet-D values.
Measured: 6 months
Major Amputation
Major amputation, defined as amputation above the ankle joint, will be associated with Flowmet-D values.
Measured: 6 months
Minor Amputation
Minor amputation, defined as amputation below the ankle joint, will be associated with Flowmet-D values.
Measured: 6 months
Repeat Revascularization
Repeat Revascularization, defined as unplanned repeat lower extremity revascularization, will be monitored.
Measured: 6 months
Secondary outcomes (1)
Response to Hyperbaric Oxygen Therapy
Response to Hyperbaric Oxygen Therapy, will be defined as improved perfusion (improved Flowmet-D value) following therapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start27 Apr 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Endovascular, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Venita Chandra, Stanford University
- Investigators
- Venita Chandra, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455554
- Sponsor's protocol ID
- 62133
- Other IDs
- 5R38HL143615-02
- Status last verified
- Jul 2022
- First submitted
- 14 Dec 2021
- Last updated
- 13 Jul 2022
- 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 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of FlowMet-R Technology to Predict Wound Healing in Critical Limb Ischemia (CLI) Patients in a Wound Care Center Setting
- ClinicalTrials.gov ID
- NCT05455554
- Acronym / sponsor ID
- 62133
- Conditions
- Critical Limb Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Medtronic Endovascular, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 13 Jul 2022 (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.
Single-institution, prospective nonrandomized pilot study of critical limb ischemia patients with planned lower extremity revascularization will undergo Flowmet-D measurements in a wound care center setting to determine threshold values associated with wound healing and amputation. A subset of patients will undergo hyperbaric oxygen therapy and will have Flowmet-D measurements to determine those who respond best to therapy.
Detailed description
A single-institution, prospective nonrandomized pilot study will be conducted at Stanford Hospital and the Stanford Advanced Wound Care Center (AWCC). Patients with CLTI by WIfI criteria (ABI or toe pressures) and a concomitant non-healing lower extremity wound will be recruited. Inclusion criteria will include CLTI, at least one active lower extremity wound and planned lower extremity revascularization. ABI/TBIs will be recorded preintervention, post intervention and at one and three month intervals. Intraprocedural characteristics including the number and location of vessels revascularized, patent runoff vessels pre and post procedure, pedal arch anatomy and presence of angiographic "blush" to wound will be documented.
Post-operatively, patients will be followed at the AWCC where they will receive standard of care wound management including offloading, regular debridement, infection and edema management. FlowMet-R perfusion values will be obtained prerevascularization, immediately post revascularization as well as weekly at each follow up AWCC visit for a total of up to 6 months or until wound healing.Wound size will be recorded.
Patients who undergo hyperbaric oxygen therapy (at the discretion of AWCC surgeon) will have perfusion values performed before and after hyperbaric oxygen therapy sessions 1, 2, 10, 20, 30 and 40. Hyperbaric oxygen therapy will be conducted 5 days a week for duration of 90 minutes. Patients who undergo other advanced wound care treatments such as stem cell therapies or skin substitutes will also received FlowMet-R prior to and after treatment. Primary outcomes will be wound healing defined as complete skin epithelialization, wound improvement rate, major and minor amputations as well as need for repeat revascularization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLI (Critical Limb Ischemia) | – | Diagnostic Test: Flowmet-D, Diagnostic Test: ABICLI cohort is a population of individuals with CLI, at least one active lower extremity wound and planned lower extremity revascularization. CLI cohort patients will receive Flowmet-D measurements in addition to standard of care therapy following intervention. |
| HBO (Hyperbaric Oxygen) | – | Diagnostic Test: Flowmet-D, Diagnostic Test: ABIHBO cohort is a subset of the CLI cohort who will undergo hyperbaric oxygen therapy in the post-operative setting who will receive Flowmet-D measurements before and after their therapy. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The CLI population is individuals with CLTI, at least one active lower extremity wound and planned lower extremity revascularization. The HBO cohort is a subset of the CLI population who will undergo HBO therapy post-revascularization.
Key inclusion criteria (9 listed)
- CLI by WIfI criteria (ABI or toe pressures)
- Non-healing lower extremity wound
- Planned lower extremity revascularization
- Able to provide informed consent
- Able to comply with study procedures
Key exclusion criteria (2 listed)
- Under 30
- Wound not suitable for FlowMet-D probe attachment
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 |
|---|---|---|
| Flowmet-DFlowmet-D is a non-invasive device that measures blood flow. | Diagnostic test | CLI (Critical Limb Ischemia), HBO (Hyperbaric Oxygen) |
| ABIABI is the ratio of the systolic blood pressure measured at the ankle to that measured at the brachial artery and is considered the gold standard for the diagnosis of peripheral artery disease. | Diagnostic test | CLI (Critical Limb Ischemia), HBO (Hyperbaric Oxygen) |
Primary outcome
Wound Healing
Time frame: 6 months
Wound Healing, defined as complete skin epithelialization, will be associated with Flowmet-D measurements.
Wound Improvement
Time frame: 6 months
Wound Improvement, defined as improvement in wound size, will be associated with Flowmet-D values.
Major Amputation
Time frame: 6 months
Major amputation, defined as amputation above the ankle joint, will be associated with Flowmet-D values.
Minor Amputation
Time frame: 6 months
Minor amputation, defined as amputation below the ankle joint, will be associated with Flowmet-D values.
Repeat Revascularization
Time frame: 6 months
Repeat Revascularization, defined as unplanned repeat lower extremity revascularization, will be monitored.
1 secondary outcome
Response to Hyperbaric Oxygen Therapy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- 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.
Venita Chandra, MD principal investigator
Stanford University
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 Critical Limb Ischemia, run by Stanford University 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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Jul 2022. 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?
Results are not available in the source record.
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?
Wound Healing (time frame: 6 months). The study lists 5 primary outcomes in all. 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 13 Jul 2022.