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Clinical Trials/EUCTR2016-000240-34-PL
EUCTR2016-000240-34-PL
Active, not recruiting
Phase 1

The Efficacy and Safety of Intra-Arterial Administration of REX-001 to Treat Ischaemic Rest Pain in Subjects with Critical Limb Ischaemia Rutherford Category 4 and Diabetes Mellitus: A Pivotal, Placebo-Controlled, Double-Blind, Parallel-Group, Adaptive Trial - Salamander

Rexgenero Limited0 sites60 target enrollmentApril 3, 2017
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ConditionsCritical Limb Ischemia in patients with Diabetes MellitusMedDRA version: 21.1Level: LLTClassification code 10077142Term: Limb ischemiaSystem Organ Class: 100000004866MedDRA version: 21.1Level: LLTClassification code 10058069Term: Critical limb ischemiaSystem Organ Class: 100000004866MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Critical Limb Ischemia in patients with Diabetes Mellitus
Sponsor
Rexgenero Limited
Enrollment
60
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 3, 2017
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Rexgenero Limited

Eligibility Criteria

Inclusion Criteria

  • •To be eligible for this trial subjects must satisfy all of the following criteria:
  • •1\. Aged \= 18 to \= 85 years.
  • •2\. Diagnosis of Type I or II DM, established more than one year ago.
  • •3\. Subjects with poor or no (surgical or endovascular) revascularization option classified as CLI Rutherford Category 4\.
  • •The blood circulation in these subjects must be compromised at screening defined as:
  • •Ankle systolic pressure \< 50 mm Hg, or
  • •Toe systolic pressure \< 30 mm Hg, or
  • •TcpO2 \< 30 mm Hg, and
  • •Flat or barely pulsatile ankle or metatarsal PVR
  • •The subject should have rest pain without tissue loss, and the rest pain must be persistent and require analgesics for at least two weeks for the subject to be eligibile. Subjects with non\-compressible or calcified vessels must qualify on toe pressure or tcpO2\.

Exclusion Criteria

  • •Subjects meeting any of the following criteria must not be enrolled in the trial:
  • •1\. Advanced CLI defined as presence of major tissue loss (i.e. significant ulceration and/or gangrene) proximal to the metatarsal heads (CLI 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\. CLI Rutherford Category 5\.
  • •3\. Uncontrolled or untreated proliferative retinopathy.
  • •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 ischemia 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.

Outcomes

Primary Outcomes

Not specified

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