Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds

NCT ID: NCT01230567

Last Updated: 2013-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-04-30

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.

Conditions

Wounds and Injuries

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yaron Har-Shai

head of plastic surgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yaron Har-Shai, Prof

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

Carmel Medical Center

Haifa, , Israel

Countries

Israel

Other Identifiers

CMC-10-0032 CTIL

Identifier Type: -

Identifier Source: org_study_id