Necrotizing FasciitisNCT00538577
Outcome and Related Factors of Necrotizing Fasciitis of the Limb
An observational study of Necrotizing Fasciitis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Soft tissue necrotizing fasciitis of limbs are lethal infections and associated with high morbidity and mortality rates. The purpose of this study is to determine the clinical manifestations and factors affected the treatment outcome to predict the prognosis and make timely decision for appropriate management and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Necrotizing Fasciitis
- How many people
- 25 participants
- Where
- 1 siteIran
- Study dates
- Sep 2007to Sep 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Patients with diagnosis of necrotiying faciitis
Who may be able to join
- Necrotizing fasciitis of the limb
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Operative Theater of Orthopedic Surgery Department- Imam Khomeini Hospital
Tehran, Tehran Province
About this study
Soft tissue necrotizing fasciitis of limbs are lethal infections and associated with high morbidity and mortality rates. The purpose of this study is to determine the clinical manifestations and factors affected the treatment outcome to predict the prognosis and make timely decision for appropriate management and prevent limb loss.
Read the detailed description
Patients that are admitted to hospital with the diagnosis of necrotizing fasciitis of a limb will be entered to this study. A questionnaire will be completed for each patient included demographic data, admission and diagnosis date, treatment onset, medical history for diabetes mellitus, HIV infection, use of immunosuppressor drugs, peripheral vascular disease, cancer, renal disease, intravenous drug abuse, and disease outcome that can be recovery, amputation or death.
- Conditions
- Necrotizing Fasciitis
- Keywords
- Necrotizing fasciitis
- Medical subject headings
- Fasciitis, Necrotizing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing FasciitisStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Ramin Espandar, MD, Principal investigator, Imam Khomeini Hospital- Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538577
- Sponsor's protocol ID
- 86-03-30-6110
- Status last verified
- Oct 2009
- First submitted
- 30 Sep 2007
- Last updated
- 6 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome and Related Factors of Necrotizing Fasciitis of the Limb
- ClinicalTrials.gov ID
- NCT00538577
- Acronym / sponsor ID
- 86-03-30-6110
- Conditions
- Necrotizing Fasciitis
- Keywords
- Necrotizing fasciitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 2 Oct 2007 (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.
Soft tissue necrotizing fasciitis of limbs are lethal infections and associated with high morbidity and mortality rates. The purpose of this study is to determine the clinical manifestations and factors affected the treatment outcome to predict the prognosis and make timely decision for appropriate management and prevent limb loss.
Detailed description
Patients that are admitted to hospital with the diagnosis of necrotizing fasciitis of a limb will be entered to this study. A questionnaire will be completed for each patient included demographic data, admission and diagnosis date, treatment onset, medical history for diabetes mellitus, HIV infection, use of immunosuppressor drugs, peripheral vascular disease, cancer, renal disease, intravenous drug abuse, and disease outcome that can be recovery, amputation or death.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Patients with diagnosis of necrotiying faciitis
Key inclusion criteria (1 listed)
- Necrotizing fasciitis of the limb
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 6 Oct 2009.
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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.
Ramin Espandar, MD principal investigator
Imam Khomeini Hospital- Tehran University of Medical Sciences
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 Necrotizing Fasciitis, run by Tehran University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 0 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 6 Oct 2009. 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 Iran. 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.
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 6 Oct 2009.