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Pilot Safety Study of Injectable SIS for Critical Limb Ischemia (CLIC)

Primary Purpose

Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Injectable SIS
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia focused on measuring critical limb ischemia, wound healing, amputation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of critical limb ischemia
  • Rutherford 4-5 or Leriche-Fontaine IIIB
  • Patient unable to be treated by endovascular or surgical means

Exclusion Criteria:

  • 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

Sites / Locations

  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Injectable SIS

Outcomes

Primary Outcome Measures

Frequency and types of adverse events after treatment with the Cook Injectable SIS

Secondary Outcome Measures

Full Information

First Posted
May 21, 2014
Last Updated
December 19, 2017
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02145845
Brief Title
Pilot Safety Study of Injectable SIS for Critical Limb Ischemia
Acronym
CLIC
Official Title
Pilot Safety Study of Injectable Small Intestine Submucosa (SIS) for Critical Limb Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 5, 2017 (Actual)
Study Completion Date
November 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
Keywords
critical limb ischemia, wound healing, amputation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Injectable SIS
Intervention Type
Device
Intervention Name(s)
Injectable SIS
Intervention Description
Injectable SIS
Primary Outcome Measure Information:
Title
Frequency and types of adverse events after treatment with the Cook Injectable SIS
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of critical limb ischemia Rutherford 4-5 or Leriche-Fontaine IIIB Patient unable to be treated by endovascular or surgical means Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vaclav Prochazka, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia

12. IPD Sharing Statement

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Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

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