Comparison Between the Histological and Clinical Diagnosi... | NCT01230567

Studies
Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds

NCT01230567

Sponsor

Carmel Medical Center

Status

Completed

Last Update Posted

Apr 10, 2013Estimated

Enrollment

41Actual

Phase

Not provided

Conditions

Wounds and Injuries

Interventions

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Apr 2013Actual

First Submitted Date

Oct 28, 2010

First Submission Date that Met QC Criteria

Oct 28, 2010

First Posted Date

Oct 29, 2010Estimated

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

Apr 9, 2013

Last Update Posted Date

Apr 10, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

50 patients with non healing wounds will undergo biopsy to conclude wether there is an occult etiology for the wound.

Detailed Description

25 patients suffering from non healing wounds which have non typical features for the clinical diagnosis (such as pale granulation, raised lesions and more) will undergo biopsy of the wound.

Another 25 patients suffering from non healing wounds with typical features for the clinical diagnosis will undergo biopsy of the wound.

The hypothesis is that non healing wounds harbor undiagnosed etiologic factors such as BCC, SCC, vasculitis etc. and that some clinical features should raise our suspicion for these occult etiologies.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HISTOLOGY RESULTS	HISTOLOGY RESULTS OF ALL WOUND BIOPSIES WILL BE COLLECTED TO ASSESS THE ACCULT ETIOLOGY RATE IN NON HEALING WOUNDS.	04/2013

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with non-healing wounds (for > 6 weeks)
consent to be included in the study
age 18-85

Exclusion Criteria:

patients taking anti coagulant therapy
patients taking steroids or immunosuppressive therapy
pregnancy
pace maker

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients suffering from non healing wounds, which do not respond well to six weeks of adequate treatment.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yaron Har-Shai, Prof	Carmel Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carmel Medical Center		Haifa		34362	Israel

Type	Date	Date Unknown
Release	Dec 2, 2013
Reset	Jan 15, 2014

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 2, 2013			Jan 15, 2014

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D014657	Vasculitis

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided