Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

Pilot Safety Study of Injectable Small Intestine Submucosa (SIS) for Critical Limb Ischemia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02145845

Acronym

CLIC

Enrollment

Registered

2014-05-23

Start date

2014-04-30

Completion date

2017-11-06

Last updated

2017-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease

Keywords

critical limb ischemia, wound healing, amputation

Brief summary

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

Interventions

DEVICEInjectable SIS

Injectable SIS

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Frequency and types of adverse events after treatment with the Cook Injectable SIS	180 days

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026