Correlation Between the Volume Flow of the CFA After Angioplasty of Critical Ischemic Limb and Wound Healing

December 13, 2020 updated by: Dr. Chen Speter, Sheba Medical Center
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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Sheba Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with threatened limbs, having angioplasty .

Description

Inclusion Criteria:

  • All patients with threatened limbs, that was decided upon to have angioplasty .

Exclusion Criteria:

  • those who are not willing to sign a consent form to participate in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound healing
Time Frame: 12 months
physical examination
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Study Chair: moshe halak, dr, Sheba Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2020

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

February 20, 2024

Study Registration Dates

First Submitted

December 13, 2020

First Submitted That Met QC Criteria

December 13, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 13, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-20-7318-CP-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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