Wound Heal, Duplex Volume FlowNCT04672668
Correlation Between the Volume Flow of the CFA After Angioplasty of Critical Ischemic Limb and Wound Healing
An observational study of Wound Heal, Duplex Volume Flow, run by Sheba Medical Center at 1 site in Israel.
Trial summary
in our study we are examining the volume flow of the common femoral artery before and after angigraphy of a critical ischemic limb, as a predictor for wound healing after the treatment Read more about this study
- Who is it for?
- Ages 12 to 120 years
- Conditions the study is for
- Wound Heal, Duplex Volume Flow
- What is being tested?
- duplex ultrasound for the common femoral artery
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Dec 2020to 20 Feb 2024
- How long will I take part?
- 12 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 12 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with threatened limbs, having angioplasty .
Who may be able to join
- All patients with threatened limbs, that was decided upon to have angioplasty .
Who cannot join
- those who are not willing to sign a consent form to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
in our study we are examining the volume flow of the common femoral artery before and after angigraphy of a critical ischemic limb, as a predictor for wound healing after the treatment
Read the detailed description
All patients with threatened limbs, that was decided upon to have angioplasty will be asked to sign consent form to participate in this study.
Before having the angioplasty, all participants will be examined with ultrasound duplex to determent their common femoral artery volume flow. Day after the angioplasty, they will be reexamined (this is the usual practice) to detriment the new volume flow in the CFA.
The participents examinations in the outpatient clinics will be documented and time for healing will be recorded.
- Conditions
- Wound Heal, Duplex Volume Flow
- Being tested
- duplex ultrasound for the common femoral artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duplex ultrasound for the common femoral arteryDiagnostic test
duplex ultrasound for the common femoral artery before and after the angiography
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing
physical examination
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 posted17 Dec 2020
- Study start13 Dec 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Heal, Duplex Volume FlowStudies of the same condition, open and under way.
- More trials run by Sheba 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Chen Speter, Sheba Medical Center
- Investigators
- moshe halak, dr, Study chair, sheba health center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672668
- Sponsor's protocol ID
- SHEBA-20-7318-CP-CTIL
- Status last verified
- Dec 2020
- First submitted
- 13 Dec 2020
- Last updated
- 17 Dec 2020
- 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 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Volume Flow of the CFA After Angioplasty of Critical Ischemic Limb and Wound Healing
- ClinicalTrials.gov ID
- NCT04672668
- Acronym / sponsor ID
- SHEBA-20-7318-CP-CTIL
- Conditions
- Wound Heal, Duplex Volume Flow
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 13 Dec 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 17 Dec 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.
in our study we are examining the volume flow of the common femoral artery before and after angigraphy of a critical ischemic limb, as a predictor for wound healing after the treatment
Detailed description
All patients with threatened limbs, that was decided upon to have angioplasty will be asked to sign consent form to participate in this study.
Before having the angioplasty, all participants will be examined with ultrasound duplex to determent their common femoral artery volume flow. Day after the angioplasty, they will be reexamined (this is the usual practice) to detriment the new volume flow in the CFA.
The participents examinations in the outpatient clinics will be documented and time for healing will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with threatened limbs, having angioplasty .
Key inclusion criteria (1 listed)
- All patients with threatened limbs, that was decided upon to have angioplasty .
Key exclusion criteria (1 listed)
- those who are not willing to sign a consent form to participate in this 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 |
|---|---|---|
| duplex ultrasound for the common femoral arteryduplex ultrasound for the common femoral artery before and after the angiography | Diagnostic test | – |
Primary outcome
wound healing
Time frame: 12 months
physical examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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.
moshe halak, dr study chair
sheba health center
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, Duplex Volume Flow, run by Sheba Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 17 Dec 2020. 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 Israel. 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: 12 months). 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 17 Dec 2020.