The Efficacy and Safety of Intra-Arterial Administration of REX-001 to Treat Ischaemic Ulcers in Subjects with Chronic Limb Threatening Ischaemia Rutherford Category 5 and Diabetes Mellitus: A Pivotal, Placebo-Controlled, Double-Blind, Parallel-Group, Adaptive Trial - Salamander

Ixaka Limited0 sites60 target enrollmentFebruary 3, 2020

ConditionsChronic Limb Threatening Ischemia in patients with Diabetes Mellitus MedDRA version: 21.1Level: LLTClassification code 10077142Term: Limb ischemiaSystem Organ Class: 100000004866 MedDRA version: 24.0Level: LLTClassification code 10058069Term: Critical limb ischemiaSystem Organ Class: 100000004866 MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic Limb Threatening Ischemia in patients with Diabetes Mellitus
Sponsor: Ixaka Limited
Enrollment: 60
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 3, 2020

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Ixaka Limited

Eligibility Criteria

Inclusion Criteria

•1\.Aged \= 18 to \= 85 years.
•2\.Diagnosis of Type I or II DM, established more than one year ago.
•3\.Glycosylated haemoglobin (HbA1c) \< 9%.
•4\.Subjects with poor or no (surgical or endovascular) revascularization option classified as CLTI Rutherford Category 5\.
•The blood circulation in these subjects must be compromised at screening, and can be defined as:
•Ankle systolic pressure \< 70 mmHg, or
•Toe systolic pressure \< 50 mmHg, or
•TcpO2 \< 30 mmHg (lying down).
•Subjects with non\-compressible or calcified vessels must qualify on toe pressure or tcpO2\.
•Poor or no revascularization option means that, in the opinion of the Investigator, revascularization using surgical or endovascular methods are not feasible due to for example the anatomy of existing vessels, existing comorbidity and/or previously failed surgical or endovascular revascularization.

Exclusion Criteria

•1\.Advanced CLTI defined as presence of major tissue loss, i.e., significant ulceration/gangrene proximal to the metatarsal heads (CLTI Rutherford Category 6\). Significant ulceration/gangrene means any ulceration that extends beyond the subcutaneous tissue layer, or any gangrene or tissue necrosis proximal to the metatarsal heads.
•2\.CLTI Rutherford Category 4\.
•3\.Uncontrolled or untreated proliferative retinopathy (this refers to signs of neovascularization or impaired visual acuity due to retinal oedema for which the patient is not receiving appropriate treatment at the time of enrolment; or if the condition of retinopathy is concluded to be refractory to treatment).
•4\.Failed surgical or endovascular revascularization on the index leg within 10 days prior to screening
•5\.Subjects in whom arterial insufficiency in the lower extremity is the result of acute limb ischaemia or an immunological or inflammatory or non\-atherosclerotic disorder (e.g., thromboangiitis obliterans (Buerger’s Disease), or systemic sclerosis (both limited and diffuse forms).
•6\.Clinical evidence of invasive infection on index leg defined as major tissue loss at the mid\-foot or heel involving tendon and/or bone, and/or when intravenous antibiotics are required to treat the infection according to the Investigator.
•7\.At screening, the presence of only neuropathic ulcers on the index leg.
•8\.Amputation at or above the talus on the index leg.
•9\.Planned major amputation within the first month after randomization.
•10\.On the index leg, use of concomitant wound treatments not currently approved for ischaemic wound\-healing within 30 days prior to screening or plans to initiate new treatments (not standard of care) to the index leg during the trial.