Correlation Between the Volume Flow of the CFA After Angi... | NCT04672668

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

NCT04672668

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Dec 17, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Wound Heal, Duplex Volume Flow

Interventions

duplex ultrasound for the common femoral artery

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 13, 2020Actual

Primary Completion Date

Dec 30, 2021Estimated

Completion Date

Feb 20, 2024Estimated

First Submitted Date

Dec 13, 2020

First Submission Date that Met QC Criteria

Dec 13, 2020

First Posted Date

Dec 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2020

Last Update Posted Date

Dec 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
duplex ultrasound for the common femoral artery	Diagnostic Test	duplex ultrasound for the common femoral artery before and after the angiography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
wound healing	physical examination	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

All patients with threatened limbs, having angioplasty .

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
moshe halak, dr	sheba health center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Health Center		Ramat Gan			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018616	Ultrasonography, Doppler, Duplex

Ancestor Terms

ID	Term
D018608	Ultrasonography, Doppler
D014463	Ultrasonography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided