Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds

Wounds and Injuries Clinical Trial

Official title:

Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230567
• Other study ID #: CMC-10-0032 CTIL
• Status: Completed
• Phase: N/A
• First received: October 28, 2010
• Last updated: April 9, 2013
• Start date: October 2010
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Wounds and Injuries

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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