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Clinical Trials/EUCTR2016-003980-21-DE
EUCTR2016-003980-21-DE
Active, not recruiting
Phase 1

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

Rexgenero Limited0 sites60 target enrollmentOctober 10, 2016
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ConditionsCritical Limb Ischemia in patients with Diabetes MellitusMedDRA version: 20.0Level: LLTClassification code 10077142Term: Limb ischemiaSystem Organ Class: 100000004866MedDRA version: 20.0Level: 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
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 10, 2016
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Rexgenero Limited

Eligibility Criteria

Inclusion Criteria

  • •Trial Population
  • •Main Inclusion 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 5\.
  • •The blood circulation in these subjects must be compromised at screening, defined as:
  • •Ankle systolic pressure \< 70 mmHg, or
  • •Toe systolic pressure \< 50 mmHg, or
  • •Transcutaneous oxygen pressure (tcpO2\) \< 30 mmHg (lying down).
  • •Subjects with non\-compressible vessels must qualify on toe pressure or tcpO2\.

Exclusion Criteria

  • •Main Exclusion Criteria
  • •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 4\.
  • •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 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 according to the Investigator intravenous antibiotics are required to treat the infection.
  • •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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