Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds

April 9, 2013 updated by: Yaron Har-Shai, Carmel Medical Center
50 patients with non healing wounds will undergo biopsy to conclude wether there is an occult etiology for the wound.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

41

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
      • Haifa, Israel, 34362
        • Carmel Medical 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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

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

Collaborators and Investigators

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

Sponsor

Carmel Medical Center

Investigators

  • Principal Investigator: Yaron Har-Shai, Prof, Carmel Medical 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

October 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 28, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (Estimate)

October 29, 2010

Study Record Updates

Last Update Posted (Estimate)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-10-0032 CTIL

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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