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Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds

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ClinicalTrials.gov Identifier: NCT01230567
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : April 10, 2013
Sponsor:
Information provided by (Responsible Party):
Yaron Har-Shai, Carmel Medical Center

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

Condition or disease
Wounds and Injuries

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.

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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds
Study Start Date : October 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from non healing wounds, which do not respond well to six weeks of adequate treatment.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230567


Locations
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Israel
Carmel Medical Center
Haifa, Israel, 34362
Sponsors and Collaborators
Carmel Medical Center
Investigators
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Principal Investigator: Yaron Har-Shai, Prof Carmel Medical Center
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Responsible Party: Yaron Har-Shai, head of plastic surgery department, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01230567    
Other Study ID Numbers: CMC-10-0032 CTIL
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: April 10, 2013
Last Verified: April 2013
Keywords provided by Yaron Har-Shai, Carmel Medical Center:
Problem wounds
Non healing wounds
BCC
SCC
Vasculitis
Additional relevant MeSH terms:
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Wounds and Injuries