Critical Limb IschemiaNCT01311011
Study of the Clinical Efficacy of Autologous SCT in Patients With Critical Limb Ischemia
An observational study of Critical Limb Ischemia, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia Read more about this study
- Who is it for?
- Ages 14 to 85 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- SCT
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Nov 2008to not given
- 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 14 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Critical Limb Ischemia
Who may be able to join
- Patients with Critical Limb Ischemia
Who cannot join
- Patients with other than Critical Limb Ischemia
Trial locations and contacts
1 site in 1 country.
H Al-Zahrani, M.D. contact
About this study
Official title: Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in Patients With Critical Limb Ischemia
Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia
Read the detailed description
Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia
- Conditions
- Critical Limb Ischemia
- Being tested
- SCT
- Keywords
- Critical Limb Ischemia
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTProcedure or surgery
SCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- H Al-Zahrani, M.D., Principal investigator, KFSH & RC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311011
- Sponsor's protocol ID
- RAC# 2081-026
- Other IDs
- RAC# 2081-026
- Status last verified
- Dec 2011
- First submitted
- 6 Mar 2011
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in Patients With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT01311011
- Acronym / sponsor ID
- RAC# 2081-026
- Conditions
- Critical Limb Ischemia
- Keywords
- Critical Limb Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Nov 2008
- First posted
- 9 Mar 2011 (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.
Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia
Detailed description
Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Critical Limb Ischemia
Key inclusion criteria (1 listed)
- Patients with Critical Limb Ischemia
Key exclusion criteria (1 listed)
- Patients with other than Critical Limb Ischemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCTSCT | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
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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.
H Al-Zahrani, M.D. contact
H Al-Zahrani, M.D. principal investigator
KFSH & RC
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 Critical Limb Ischemia, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Dec 2011. 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact H Al-Zahrani, M.D. (+966-1-4423949), or a site near the patient. 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 13 Dec 2011.