Stem cells for peripheral vascular disease

Phase 1

• Conditions: Peripheral vascular (arterial) disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12611000011987
• Lead Sponsor: Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Inoperable peripheral arterial disease (PAD) with rest pain or non healing ulcer

Exclusion Criteria

Recent acute coronary disease, severe other life threatening illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the change in ABI (ratio of blood pressure in the arm to ankle). This outcome will be performed by conducting a between groups comparison of the change in ABI from baseline to follow-up.[4 weeks and 3 months following randomization]

Secondary Outcome Measures

Name	Time	Method
The secondary outcome is the pain free walk time. Subjects will be asked to walk at 3km/h on a treadmill at 12 degrees inclination until they develop pain in one or both legs. The test will also be stopped by chest pain or arrhythmia.[4 weeks and 3 months];Quality of Life Questionnaire Short Form 36[4 weeks and 3 months];Transcutaneous oxygen tension in toes[4 weeks and 3 months]