Wounds and InjuriesNCT01230567
Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds
An observational study of Wounds and Injuries, run by Carmel Medical Center at 1 site in Israel.
Trial summary
50 patients with non healing wounds will undergo biopsy to conclude wether there is an occult etiology for the wound. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Wounds and Injuries
- How many people
- 41 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from non healing wounds, which do not respond well to six weeks of adequate treatment.
Who may be able to join
- patients with non-healing wounds (for > 6 weeks)
- consent to be included in the study
- age 18-85
Who cannot join
- patients taking anti coagulant therapy
- patients taking steroids or immunosuppressive therapy
- pregnancy
- pace maker
Trial locations and contacts
1 site in 1 country.
About this study
50 patients with non healing wounds will undergo biopsy to conclude wether there is an occult etiology for the wound.
Read the 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
- Keywords
- Problem wounds, Non healing wounds, BCC, SCC, Vasculitis
- Medical subject headings
- Wounds and Injuries, Vasculitis
What is being measured
The primary outcome is the main question the study is designed to answer.
HISTOLOGY RESULTS
HISTOLOGY RESULTS OF ALL WOUND BIOPSIES WILL BE COLLECTED TO ASSESS THE ACCULT ETIOLOGY RATE IN NON HEALING WOUNDS.
Measured: 04/2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaron Har-Shai, Carmel Medical Center
- Investigators
- Yaron Har-Shai, Prof, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230567
- Sponsor's protocol ID
- CMC-10-0032 CTIL
- Status last verified
- Apr 2013
- First submitted
- 28 Oct 2010
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds
- ClinicalTrials.gov ID
- NCT01230567
- Acronym / sponsor ID
- CMC-10-0032 CTIL
- Conditions
- Wounds and Injuries
- Keywords
- Problem wounds, Non healing wounds, BCC, SCC, Vasculitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 29 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from non healing wounds, which do not respond well to six weeks of adequate treatment.
Key inclusion criteria (3 listed)
- patients with non-healing wounds (for > 6 weeks)
- consent to be included in the study
- age 18-85
Key exclusion criteria (4 listed)
- patients taking anti coagulant therapy
- patients taking steroids or immunosuppressive therapy
- pregnancy
- pace maker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaron Har-Shai, Prof principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HISTOLOGY RESULTS (time frame: 04/2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2013.