A Phase I/IIa Study of DVC1-0101 in Subjects with Intermittent Claudication or Critical Limb Ischaemia Secondary to Peripheral Artery Disease

Phase 1

• Conditions: Intermittent claudication secondary to peripheral artery disease; Critical limb ischaemia secondary to peripheral artery disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12615001144505
• Lead Sponsor: CMAX - a division of IDT Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-28
• Study Completion: 2018-09-20
• Last Update Posted: 3 October 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Diagnosis of PAD secondary to atherosclerosis, confirmed by medical history and one of the following observed in either leg at the screening visit:
a.Resting ABI less than or equal to 0.90
b.Resting ABI greater than 0.90 and less than or equal to 1.30, with a reduction of greater than or equal to 0.20 in ABI when measured within 2 minutes after completion of treadmill exercise.
c.TBI less than 0.75 if the subject has non-compressible calf arteries. i.e. Rutherford category 1-5. (Rutherford RJ, 1997)

Claudication symptoms of stable severity for at least 3 months prior to screening OR the highest ACD from either the screening or baseline exercise treadmill test (ETT), utilizing a modified Gardner protocol, must be between 1 and 12 minutes (inclusive).

Exclusion Criteria

PAD secondary to non-atherosclerotic conditions.

Proximal severe obstructive disease amenable to revascularisation.

Lower extremity amputation(s), including a toe amputation, which interfere(s) with walking on the treadmill.

Percutaneous revascularization procedure within 3 months prior to Screening, or procedures that are planned during the study.

Poorly controlled diabetes mellitus as evidenced by a haemoglobin A1C (HbA1c) > 12%.

Coronary artery bypass graft surgery (CABG), open peripheral vascular revascularization, or major surgical procedures within 3 months prior to screening, or planned at any time during the study

Unstable cardiovascular disease (CVD), defined as unstable both by clinical criteria and / or major changes in medication within 3 months prior to Screening or Baseline of the Extension Period.

History of congestive heart failure (CHF) or presence of CHF as defined by modified Framingham criteria class II- IV.

Myocardial infarction (MI) within 3 months prior to Screening or at Baseline of the Extension Period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified