Critical Limb IschemiaCLICNCT02145845
Pilot Safety Study of Injectable SIS for Critical Limb Ischemia
A study testing Injectable SIS in people with Critical Limb Ischemia and Peripheral Arterial Disease, run by Cook Group Incorporated at 1 site in Czechia.
Trial summary
This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS) Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- What is being tested?
- Injectable SIS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCzechia
- Study dates
- Apr 2014to 6 Nov 2017
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of critical limb ischemia
- Rutherford 4-5 or Leriche-Fontaine IIIB
- Patient unable to be treated by endovascular or surgical means
Who cannot join
- Patient's age is <21
- Patient is pregnant or breast-feeding (or is planning to become pregnant within the next year)
- Patient has had a previous surgery, within 30 days of the study procedure
- Patient has any planned surgical or interventional procedure within 30 days after the study procedure
- Patient has a life expectancy less than 1 year
- Patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue
- Additional restrictions as specified in the Clinical Investigation Plan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Safety Study of Injectable Small Intestine Submucosa (SIS) for Critical Limb Ischemia
This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)
- Being tested
- Injectable SIS
- Keywords
- critical limb ischemia, wound healing, amputation
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable SISDevice
Injectable SIS
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Injectable SIS Receives: Device: Injectable SIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and types of adverse events after treatment with the Cook Injectable SIS
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startApr 2014
- Primary completion5 Jun 2017
- Study completion6 Nov 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vaclav Prochazka, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145845
- Sponsor's protocol ID
- 11-013
- Acronym
- CLIC
- Status last verified
- Dec 2017
- First submitted
- 21 May 2014
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Safety Study of Injectable Small Intestine Submucosa (SIS) for Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT02145845
- Acronym / sponsor ID
- CLIC / 11-013
- Keywords
- critical limb ischemia, wound healing, amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- 5 Jun 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 23 May 2014 (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.
This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Injectable SISInjectable SIS |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of critical limb ischemia
- Rutherford 4-5 or Leriche-Fontaine IIIB
- Patient unable to be treated by endovascular or surgical means
Key exclusion criteria (7 listed)
- Patient's age is <21
- Patient is pregnant or breast-feeding (or is planning to become pregnant within the next year)
- Patient has had a previous surgery, within 30 days of the study procedure
- Patient has any planned surgical or interventional procedure within 30 days after the study procedure
- Patient has a life expectancy less than 1 year
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 |
|---|---|---|
| Injectable SISInjectable SIS | Device | Treatment |
Primary outcome
Frequency and types of adverse events after treatment with the Cook Injectable SIS
Time frame: 180 days
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 21 Dec 2017.
Related trials for Critical Limb Ischemia
RecruitingObservational study
miRNAs in Critical Limb Ischemia (miRNACLI)
Critical Limb Ischemia
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
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.
Vaclav Prochazka, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable SIS in people with Critical Limb Ischemia and Peripheral Arterial Disease, run by Cook Group Incorporated at 1 site in Czechia.
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 7 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 21 Dec 2017. 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 Czechia. 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?
Frequency and types of adverse events after treatment with the Cook Injectable SIS (time frame: 180 days). 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 21 Dec 2017.