Critical Limb IschemiaNCT03094559
Correlation Between FlowMet™ and Other Gold Standard Assessments in the Management of Critical Limb Ischemia (CLI)
A study testing FlowMet in people with Critical Limb Ischemia, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the utility of the FlowMet™ device in the assessment of perfusion in subjects suspected of or being treated for critical limb ischemia, in comparison to other gold standard technologies, such as ankle brachial pulse index (ABI), skin perfusion pressure (SPP), toe brachial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- FlowMet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2017to Jun 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is willing and able to provide an informed consent.
- Subject is willing and able to comply with the study procedures.
- Subject is able to understand the study procedures.
- Subject is being seen at the clinic for the evaluation/treatment of CLI.
- Subject has a Rutherford score of V or VI.
Who cannot join
- Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- Anyone with a latex allergy
- Must be over 18 years old
- Must not be pregnant during time of study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between FlowMet™, ABI, SPP, TBI, TcPO2 and Angiography
The purpose of this study is to demonstrate the utility of the FlowMet™ device in the assessment of perfusion in subjects suspected of or being treated for critical limb ischemia, in comparison to other gold standard technologies, such as ankle brachial pulse index (ABI), skin perfusion pressure (SPP), toe brachial pulse index (TBI), transcutaneous oxygen tension (TcP02), and angiography currently in use in the clinic.
Read the detailed description
TRIAL OBJECTIVES
1.0
To demonstrate that the FlowMet is effective for the assessment of tissue perfusion compared to gold standard technologies in patients suspected of or being treated for CLI.
2.0 STUDY DESIGN
This is a single center, cross-sectional study of subjects who are scheduled for CLI assessment with a Rutherford score of V and VI.
The subjects will be evaluated at baseline for determination if they meet the inclusion/exclusion criteria of the protocol. If the subject is eligible to enroll in the trial and they have signed an informed consent form (ICF) and are scheduled for evaluation, they will be enrolled. Subjects will undergo FlowMet, ABI, SPP, TBI, TcPO2, and angiography measurements (if not performed previously). The correlation between the aforementioned standard clinical measurements and FlowMet measurements will be assessed.
As ABI, SPP, TBI, TcPO2, Rutherford score, time of surgical (re)admission, speed of wound healing, and angiography measurements will likely change over a period of one year following initial FlowMet measurements, future measurements up to one year post FlowMet measurement (and performed as a standard of care) may also be correlated to initial FlowMet measurements to assess the whether FlowMet data is correlated to long-term patient outcomes.
3.0 STUDY PROCEDURES
3.1 Randomization, Blinding and Subject Identification
This is a cross-sectional study of subjects being treated for CLI with a Rutherford score of V or VI. No randomization scheme is required.
3.2 Product Equipment (FlowMet)
All parts of the FlowMet were manufactured in facilities with ISO 9001:2008 certification. Instruments are constructed in an ISO 9 cleanroom. All materials intended to be in contact with the patient's skin are constructed of polydimethylsiloxane (silicone) rubber which was sterilized via autoclave prior to device construction. Polydimethylsiloxane is widely used in existing medical devices and has been shown to be safe for both short-term contact, as well as long-term implantation (The AMS Sphincter 800™ Urinary Prosthesis, PMA P000053). Between uses, all polydimethylsiloxane components, in addition to all components which can accidentally contact a patient's skin during use, can be sanitized using alcohol wipes or germicidal wipes, such as alcohoPSI Inc. Sani-Cloths, which are commonly used in hospitals and which are bactericidal, tuberculocidal, and virucidal. The FlowMet has been used on 37 patients without adverse events at the University of California, Irvine in a study of tissue optical properties approved and overseen by the University of California, Irvine IRB. The FlowMet has not been evaluated, cleared or approved for use by the FDA.
3.3 Details of FlowMet usage
Extremity perfusion measurements will be performed using the FlowMet peripheral perfusion device. All extremity blood flow measurements will be collected during room air inhalation.
3.3.1
- The FlowMet device will be placed on the index finger of the right hand. Signal fidelity will be assured by confirming the presence of a pulse waveform if one is expected and by assuring that an appropriate amount of light is be detected by the FlowMet device. The following light intensity values are acceptable: maximum intensity greater than 25 but less than 255 and average subtracted intensity greater than 20 but less than 175. ii. Following placement of the FlowMet device, a period of 10 seconds will be allowed to elapse to allow transient changes in perfusion due to device placement to diminish. iii. FlowMet blood flow data will be recorded for 20 seconds using the FlowMet data acquisition software. iv. Steps i-iii will be repeated for digits 1 and 2 on the limb with diagnosed or suspected CLI, or on both limbs if both are diagnosed or suspected of having CLI. All data sets will be saved, and blood flow in each digit will be computed as the average of the collected data over the 20 second data collection period. If alternative digits are used for data acquisition due to differences in physiology, this will be recorded. If subject is missing the aforementioned toes, the tester will choose a different set of digits and this change will be recorded.
4.0 STUDY PROCEDURES
4.1 Baseline and Assessment
The Cleveland Clinic's standard of care will be followed for all participating study subjects. The following procedures will be conducted as part of a baseline assessment:
- Informed consent
- Complete medical history
- Demographics
- Vital signs (heart rate and blood pressure), height and weight
- Record angiographic data for study (if available)
The following procedures are standard of care and will be conducted to assess perfusion:
- Ankle brachial pulse index (ABI)
- Skin Perfusion Pressure (SPP)
- Toe brachial pulse index (TBI)
- Transcutaneous oxygen tension (TcP02)
- Angiography (if not performed previously)
The following procedures are not standard of care and will be conducted to assess perfusion:
- FlowMet measurement on subject's hand and foot/feet
- Conditions
- Critical Limb Ischemia
- Being tested
- FlowMet
- Keywords
- peripheral arterial disease
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowMetDevice
The FlowMet device will be placed on the index finger of the right hand. Signal fidelity will be assured by confirming the presence of a pulse waveform if one is expected and by assuring that an appropriate amount of light is be detected by the FlowMet device. Following placement of the FlowMet device, a period of 10 seconds will be allowed to elapse to allow transient changes in perfusion due to device placement to diminish. FlowMet blood flow data will be recorded for 20 seconds using the FlowMet data acquisition software. These steps will be repeated for digits 1 and 2 on the limb with diagnosed or suspected CLI, or on both limbs if both are diagnosed or suspected of having CLI.
| Study group | Role | What they receive |
|---|---|---|
| FlowMet device | Experimental | This is a feasibility study Receives: Device: FlowMet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between FlowMet perfusion values and ankle-brachial index and toe-brachial index in 34 patients who present to outpatient clinic.
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to ABI and TBI. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal values of well established testing. Normal values of ABI (ratios of > 0.9 to < 1.3) and TBI (ratios of > 0.7).
Measured: One year
Correlation between FlowMet perfusion values and skin perfusion pressure in 34 patients who present to outpatient clinic.
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to skin perfusion pressure testing. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal values of well established testing. Normal values of SPP are 40-50 mmHg.
Measured: One year
Correlation between FlowMet perfusion values and transcutaneous oxygen tension in 34 patients who present to outpatient clinic.
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to transcutaneous oxygen testing. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal values of well established testing. Normal value at the foot is 40-50 mmHg.
Measured: One year
Correlation between FlowMet perfusion values and angiography in 34 patients who present to outpatient clinic.
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to angiography. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal angiographic images as defined by severity of stenosis.
Measured: One year
Secondary outcomes (3)
Correlation between FlowMet perfusion values and Rutherford score
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to Rutherford score of patient at time of evaluation.
Measured: One year
Correlation between FlowMet perfusion values and time of surgical (re)admission
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude to determine timing of surgical (re)admission (days).
Measured: One year
Correlation between FlowMet perfusion values and speed of wound healing
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude to determine speed of wound healing (days).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start7 Mar 2017
- Primary completionJan 2018 (estimated)
- Study completionJun 2018 (estimated)
Why it stopped: Investigator leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehdi Shishehbor, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094559
- Sponsor's protocol ID
- 16-1223
- Status last verified
- Apr 2017
- First submitted
- 7 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Publications
Anderson RR, Parrish JA. The optics of human skin. J Invest Dermatol. 1981 Jul;77(1):13-9. doi: 10.1111/1523-1747.ep12479191.
PubMed 7252245Wilson BC, Adam G. A Monte Carlo model for the absorption and flux distributions of light in tissue. Med Phys. 1983 Nov-Dec;10(6):824-30. doi: 10.1118/1.595361.
PubMed 6656695Got I. [Transcutaneous oxygen pressure (TcPO2): advantages and limitations]. Diabetes Metab. 1998 Sep;24(4):379-84. French.
PubMed 9805653Zwicky S, Mahler F, Baumgartner I. Evaluation of clinical tests to assess perfusion in chronic critical limb ischemia. Vasa. 2002 Aug;31(3):173-8. doi: 10.1024/0301-1526.31.3.173.
PubMed 12236021Jakobsson A, Nilsson GE. Prediction of sampling depth and photon pathlength in laser Doppler flowmetry. Med Biol Eng Comput. 1993 May;31(3):301-7. doi: 10.1007/BF02458050.
PubMed 8412384Sprengers RW, Teraa M, Moll FL, de Wit GA, van der Graaf Y, Verhaar MC; JUVENTAS Study Group; SMART Study Group. Quality of life in patients with no-option critical limb ischemia underlines the need for new effective treatment. J Vasc Surg. 2010 Oct;52(4):843-9, 849.e1. doi: 10.1016/j.jvs.2010.04.057.
PubMed 20598482Varu VN, Hogg ME, Kibbe MR. Critical limb ischemia. J Vasc Surg. 2010 Jan;51(1):230-41. doi: 10.1016/j.jvs.2009.08.073.
PubMed 20117502Hirsch AT, Hartman L, Town RJ, Virnig BA. National health care costs of peripheral arterial disease in the Medicare population. Vasc Med. 2008 Aug;13(3):209-15. doi: 10.1177/1358863X08089277.
PubMed 18687757Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
PubMed 17140820Falanga V. Wound healing and its impairment in the diabetic foot. Lancet. 2005 Nov 12;366(9498):1736-43. doi: 10.1016/S0140-6736(05)67700-8.
PubMed 16291068Ouriel K. Peripheral arterial disease. Lancet. 2001 Oct 13;358(9289):1257-64. doi: 10.1016/S0140-6736(01)06351-6.
PubMed 11675083Cronberg CN, Sjoberg S, Albrechtsson U, Leander P, Lindh M, Norgren L, Danielsson P, Sonesson B, Larsson EM. Peripheral arterial disease. Contrast-enhanced 3D MR angiography of the lower leg and foot compared with conventional angiography. Acta Radiol. 2003 Jan;44(1):59-66.
PubMed 12631001Stadelmann WK, Digenis AG, Tobin GR. Impediments to wound healing. Am J Surg. 1998 Aug;176(2A Suppl):39S-47S. doi: 10.1016/s0002-9610(98)00184-6.
PubMed 9777971Mosely LH, Finseth F. Cigarette smoking: impairment of digital blood flow and wound healing in the hand. Hand. 1977 Jun;9(2):97-101. doi: 10.1016/s0072-968x(77)80001-6.
PubMed 914099Prahl, S. A., Keijzer, M., Jacques, S. L. & Welch, A. J., SPIE Proceedings of Dosimetry of Laser Radiation in Medicine and Biology. 102-111 (Proc. SPIE IS 5, 1989).
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between FlowMet™, ABI, SPP, TBI, TcPO2 and Angiography
- ClinicalTrials.gov ID
- NCT03094559
- Acronym / sponsor ID
- 16-1223
- Conditions
- Critical Limb Ischemia
- Keywords
- peripheral arterial disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator leaving institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 29 Mar 2017 (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 purpose of this study is to demonstrate the utility of the FlowMet™ device in the assessment of perfusion in subjects suspected of or being treated for critical limb ischemia, in comparison to other gold standard technologies, such as ankle brachial pulse index (ABI), skin perfusion pressure (SPP), toe brachial pulse index (TBI), transcutaneous oxygen tension (TcP02), and angiography currently in use in the clinic.
Detailed description
TRIAL OBJECTIVES
1.0
To demonstrate that the FlowMet is effective for the assessment of tissue perfusion compared to gold standard technologies in patients suspected of or being treated for CLI.
2.0 STUDY DESIGN
This is a single center, cross-sectional study of subjects who are scheduled for CLI assessment with a Rutherford score of V and VI.
The subjects will be evaluated at baseline for determination if they meet the inclusion/exclusion criteria of the protocol. If the subject is eligible to enroll in the trial and they have signed an informed consent form (ICF) and are scheduled for evaluation, they will be enrolled. Subjects will undergo FlowMet, ABI, SPP, TBI, TcPO2, and angiography measurements (if not performed previously). The correlation between the aforementioned standard clinical measurements and FlowMet measurements will be assessed.
As ABI, SPP, TBI, TcPO2, Rutherford score, time of surgical (re)admission, speed of wound healing, and angiography measurements will likely change over a period of one year following initial FlowMet measurements, future measurements up to one year post FlowMet measurement (and performed as a standard of care) may also be correlated to initial FlowMet measurements to assess the whether FlowMet data is correlated to long-term patient outcomes.
3.0 STUDY PROCEDURES
3.1 Randomization, Blinding and Subject Identification
This is a cross-sectional study of subjects being treated for CLI with a Rutherford score of V or VI. No randomization scheme is required.
3.2 Product Equipment (FlowMet)
All parts of the FlowMet were manufactured in facilities with ISO 9001:2008 certification. Instruments are constructed in an ISO 9 cleanroom. All materials intended to be in contact with the patient's skin are constructed of polydimethylsiloxane (silicone) rubber which was sterilized via autoclave prior to device construction. Polydimethylsiloxane is widely used in existing medical devices and has been shown to be safe for both short-term contact, as well as long-term implantation (The AMS Sphincter 800™ Urinary Prosthesis, PMA P000053). Between uses, all polydimethylsiloxane components, in addition to all components which can accidentally contact a patient's skin during use, can be sanitized using alcohol wipes or germicidal wipes, such as alcohoPSI Inc. Sani-Cloths, which are commonly used in hospitals and which are bactericidal, tuberculocidal, and virucidal. The FlowMet has been used on 37 patients without adverse events at the University of California, Irvine in a study of tissue optical properties approved and overseen by the University of California, Irvine IRB. The FlowMet has not been evaluated, cleared or approved for use by the FDA.
3.3 Details of FlowMet usage
Extremity perfusion measurements will be performed using the FlowMet peripheral perfusion device. All extremity blood flow measurements will be collected during room air inhalation.
3.3.1
- The FlowMet device will be placed on the index finger of the right hand. Signal fidelity will be assured by confirming the presence of a pulse waveform if one is expected and by assuring that an appropriate amount of light is be detected by the FlowMet device. The following light intensity values are acceptable: maximum intensity greater than 25 but less than 255 and average subtracted intensity greater than 20 but less than 175. ii. Following placement of the FlowMet device, a period of 10 seconds will be allowed to elapse to allow transient changes in perfusion due to device placement to diminish. iii. FlowMet blood flow data will be recorded for 20 seconds using the FlowMet data acquisition software. iv. Steps i-iii will be repeated for digits 1 and 2 on the limb with diagnosed or suspected CLI, or on both limbs if both are diagnosed or suspected of having CLI. All data sets will be saved, and blood flow in each digit will be computed as the average of the collected data over the 20 second data collection period. If alternative digits are used for data acquisition due to differences in physiology, this will be recorded. If subject is missing the aforementioned toes, the tester will choose a different set of digits and this change will be recorded.
4.0 STUDY PROCEDURES
4.1 Baseline and Assessment
The Cleveland Clinic's standard of care will be followed for all participating study subjects. The following procedures will be conducted as part of a baseline assessment:
- Informed consent
- Complete medical history
- Demographics
- Vital signs (heart rate and blood pressure), height and weight
- Record angiographic data for study (if available)
The following procedures are standard of care and will be conducted to assess perfusion:
- Ankle brachial pulse index (ABI)
- Skin Perfusion Pressure (SPP)
- Toe brachial pulse index (TBI)
- Transcutaneous oxygen tension (TcP02)
- Angiography (if not performed previously)
The following procedures are not standard of care and will be conducted to assess perfusion:
- FlowMet measurement on subject's hand and foot/feet
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FlowMet device | Experimental | Device: FlowMetThis is a feasibility study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is willing and able to provide an informed consent.
- Subject is willing and able to comply with the study procedures.
- Subject is able to understand the study procedures.
- Subject is being seen at the clinic for the evaluation/treatment of CLI.
- Subject has a Rutherford score of V or VI.
Key exclusion criteria (4 listed)
- Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- Anyone with a latex allergy
- Must be over 18 years old
- Must not be pregnant during time of study
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 |
|---|---|---|
| FlowMetThe FlowMet device will be placed on the index finger of the right hand. Signal fidelity will be assured by confirming the presence of a pulse waveform if one is expected and by assuring that an appropriate amount of light is be detected by the FlowMet device. Following placement of the FlowMet device, a period of 10 seconds will be allowed to elapse to allow transient changes in perfusion due to device placement to diminish. FlowMet blood flow data will be recorded for 20 seconds using the FlowMet data acquisition software. These steps will be repeated for digits 1 and 2 on the limb with diagnosed or suspected CLI, or on both limbs if both are diagnosed or suspected of having CLI. | Device | FlowMet device |
Primary outcome
Correlation between FlowMet perfusion values and ankle-brachial index and toe-brachial index in 34 patients who present to outpatient clinic.
Time frame: One year
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to ABI and TBI. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal values of well established testing. Normal values of ABI (ratios of > 0.9 to < 1.3) and TBI (ratios of > 0.7).
Correlation between FlowMet perfusion values and skin perfusion pressure in 34 patients who present to outpatient clinic.
Time frame: One year
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to skin perfusion pressure testing. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal values of well established testing. Normal values of SPP are 40-50 mmHg.
Correlation between FlowMet perfusion values and transcutaneous oxygen tension in 34 patients who present to outpatient clinic.
Time frame: One year
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to transcutaneous oxygen testing. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal values of well established testing. Normal value at the foot is 40-50 mmHg.
Correlation between FlowMet perfusion values and angiography in 34 patients who present to outpatient clinic.
Time frame: One year
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to angiography. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal angiographic images as defined by severity of stenosis.
3 secondary outcomes
Correlation between FlowMet perfusion values and Rutherford score
Time frame: One year
Correlation between FlowMet perfusion values and time of surgical (re)admission
Time frame: One year
Correlation between FlowMet perfusion values and speed of wound healing
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Background: PubMed 7252245Anderson RR, Parrish JA. The optics of human skin. J Invest Dermatol. 1981 Jul;77(1):13-9. doi: 10.1111/1523-1747.ep12479191.
- Background: PubMed 6656695Wilson BC, Adam G. A Monte Carlo model for the absorption and flux distributions of light in tissue. Med Phys. 1983 Nov-Dec;10(6):824-30. doi: 10.1118/1.595361.
- Background: PubMed 9805653Got I. [Transcutaneous oxygen pressure (TcPO2): advantages and limitations]. Diabetes Metab. 1998 Sep;24(4):379-84. French.
- Background: PubMed 12236021Zwicky S, Mahler F, Baumgartner I. Evaluation of clinical tests to assess perfusion in chronic critical limb ischemia. Vasa. 2002 Aug;31(3):173-8. doi: 10.1024/0301-1526.31.3.173.
- Background: PubMed 8412384Jakobsson A, Nilsson GE. Prediction of sampling depth and photon pathlength in laser Doppler flowmetry. Med Biol Eng Comput. 1993 May;31(3):301-7. doi: 10.1007/BF02458050.
- Background: PubMed 20598482Sprengers RW, Teraa M, Moll FL, de Wit GA, van der Graaf Y, Verhaar MC; JUVENTAS Study Group; SMART Study Group. Quality of life in patients with no-option critical limb ischemia underlines the need for new effective treatment. J Vasc Surg. 2010 Oct;52(4):843-9, 849.e1. doi: 10.1016/j.jvs.2010.04.057.
- Background: PubMed 20117502Varu VN, Hogg ME, Kibbe MR. Critical limb ischemia. J Vasc Surg. 2010 Jan;51(1):230-41. doi: 10.1016/j.jvs.2009.08.073.
- Background: PubMed 18687757Hirsch AT, Hartman L, Town RJ, Virnig BA. National health care costs of peripheral arterial disease in the Medicare population. Vasc Med. 2008 Aug;13(3):209-15. doi: 10.1177/1358863X08089277.
- Background: PubMed 17140820Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
- Background: PubMed 16291068Falanga V. Wound healing and its impairment in the diabetic foot. Lancet. 2005 Nov 12;366(9498):1736-43. doi: 10.1016/S0140-6736(05)67700-8.
- Background: PubMed 11675083Ouriel K. Peripheral arterial disease. Lancet. 2001 Oct 13;358(9289):1257-64. doi: 10.1016/S0140-6736(01)06351-6.
- Background: PubMed 12631001Cronberg CN, Sjoberg S, Albrechtsson U, Leander P, Lindh M, Norgren L, Danielsson P, Sonesson B, Larsson EM. Peripheral arterial disease. Contrast-enhanced 3D MR angiography of the lower leg and foot compared with conventional angiography. Acta Radiol. 2003 Jan;44(1):59-66.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
Mehdi Shishehbor principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlowMet in people with Critical Limb Ischemia, run by The Cleveland Clinic 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 13 Apr 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Correlation between FlowMet perfusion values and ankle-brachial index and toe-brachial index in 34 patients who present to outpatient clinic. (time frame: One year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094559, which also lists 16 linked publications.
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 Apr 2017.