Peripheral Arterial DiseasePhase 2NCT03012750
Angiosome Perfusion After Tibial Bypass
A Phase 2 study testing Indocyanine Green in people with Peripheral Arterial Disease, run by University Hospital Erlangen.
Trial summary
Microcirculation should be assessed before and after tibial bypass surgery by intraoperative fluorescence angiography. According to this, the direct and the indirect angiosomes should be compared according to the individual microcirculatory improvement. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Indocyanine Green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Oct 2016
- Phase
- Phase 2
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at CLI Rutherford stages IV to VI
- Patients with necessity of tibial Bypass surgery
Who cannot join
- Allergy against indocyanine green
- Iodine allergy
- Contrast allergy
- Penicillin allergy
- Allergic diathesis
- Liver insufficiency
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- Pregnancy
- Hyperthyreosis
- Pulmonary arterial hypertension
About this study
Microcirculation should be assessed before and after tibial bypass surgery by intraoperative fluorescence angiography. According to this, the direct and the indirect angiosomes should be compared according to the individual microcirculatory improvement.
Read the detailed description
Only patients at CLI stage Rutherford IV to VI with the necessity of tibial Bypass surgery will be included. Macrocirculation is measured by the ankle-brachial index (ABI). In order to assess the skin microcirculation intraoperative fluorescence angiography is used (SPY Elite™, NOVADAQ, Canada). The alteration of microcirculation is compared in direct and indirect revascularized angiosomes by calculation of the fluorescence parameters Ingress (IN) and Ingress rate (InR). Clinical Follow-up investigations will be performed and the wound healing rate is compared between the different revascularization methods.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Indocyanine Green
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Perioperative application of 0.1 mg ICG per kg Body weight
| Study group | Role | What they receive |
|---|---|---|
| foot perfusion | Experimental | intravenous application of indocyanine green in patients receiving tibial Bypass surgery Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingress)
Comparison of the fluorescence parameter Ingress in the direct and indirect revascularized angiosome before and after tibial bypass surgery
Measured: 12 months
Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingressrate)
Comparison of the fluorescence parameter Ingressrate in the direct and indirect revascularized angiosome before and after tibial bypass surgery
Measured: 12 months
Secondary outcomes (1)
Correlation of the wound healing rates with indirect and direct revascularization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startFeb 2015
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrich Rother, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012750
- Sponsor's protocol ID
- SPY-Angiosome
- Status last verified
- Jan 2017
- First submitted
- 3 Jan 2017
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rother U, Lang W, Horch RE, Ludolph I, Meyer A, Gefeller O, Regus S. Pilot Assessment of the Angiosome Concept by Intra-operative Fluorescence Angiography After Tibial Bypass Surgery. Eur J Vasc Endovasc Surg. 2018 Feb;55(2):215-221. doi: 10.1016/j.ejvs.2017.11.024. Epub 2018 Jan 3.
PubMed 29305093
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiosome Perfusion After Tibial Bypass
- ClinicalTrials.gov ID
- NCT03012750
- Acronym / sponsor ID
- SPY-Angiosome
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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.
Microcirculation should be assessed before and after tibial bypass surgery by intraoperative fluorescence angiography. According to this, the direct and the indirect angiosomes should be compared according to the individual microcirculatory improvement.
Detailed description
Only patients at CLI stage Rutherford IV to VI with the necessity of tibial Bypass surgery will be included. Macrocirculation is measured by the ankle-brachial index (ABI). In order to assess the skin microcirculation intraoperative fluorescence angiography is used (SPY Elite™, NOVADAQ, Canada). The alteration of microcirculation is compared in direct and indirect revascularized angiosomes by calculation of the fluorescence parameters Ingress (IN) and Ingress rate (InR). Clinical Follow-up investigations will be performed and the wound healing rate is compared between the different revascularization methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| foot perfusion | Experimental | Drug: Indocyanine Greenintravenous application of indocyanine green in patients receiving tibial Bypass surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients at CLI Rutherford stages IV to VI
- Patients with necessity of tibial Bypass surgery
Key exclusion criteria (9 listed)
- Allergy against indocyanine green
- Iodine allergy
- Contrast allergy
- Penicillin allergy
- Allergic diathesis
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 |
|---|---|---|
| Indocyanine GreenPerioperative application of 0.1 mg ICG per kg Body weight | Drug | foot perfusion |
Primary outcome
Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingress)
Time frame: 12 months
Comparison of the fluorescence parameter Ingress in the direct and indirect revascularized angiosome before and after tibial bypass surgery
Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingressrate)
Time frame: 12 months
Comparison of the fluorescence parameter Ingressrate in the direct and indirect revascularized angiosome before and after tibial bypass surgery
1 secondary outcome
Correlation of the wound healing rates with indirect and direct revascularization
Time frame: 12 months
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 6 Jan 2017.
- Derived from this study: PubMed 29305093Rother U, Lang W, Horch RE, Ludolph I, Meyer A, Gefeller O, Regus S. Pilot Assessment of the Angiosome Concept by Intra-operative Fluorescence Angiography After Tibial Bypass Surgery. Eur J Vasc Endovasc Surg. 2018 Feb;55(2):215-221. doi: 10.1016/j.ejvs.2017.11.024. Epub 2018 Jan 3.
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Peripheral Arterial Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indocyanine Green in people with Peripheral Arterial Disease, run by University Hospital Erlangen.
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 9 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 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingress) (time frame: 12 months). The study lists 2 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 NCT03012750, which also lists 1 linked publication.
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 6 Jan 2017.