The effectiveness and safety of quality and quantity mononuclear cells in treating chronic limb ischemia patient

Phase 3

Recruiting

• Conditions: imb ischemia; Limb ischemia, stem cell, peripheral blood mononuclear cell, quality and quantity mononuclear cells, amputation, wound healing

• Registration Number: TCTR20220502003
• Lead Sponsor: Faculty of Medicine, Siriraj Hospital, Mahidol university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-02
• Last Update Posted: 19 August 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients with CLI presented with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months

Exclusion Criteria

Gangrene extended proximally to forefoot area
Recent myocardial infarction
Severe valvular heart disease
After organ transplantation
Cardiomyopthy( EF< 25%)
Liver failure
Coagulopathy
HIV
Malignancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Limb saving 3 ,6 , 9 , 12 months Observation,Wound healing 3 ,6 , 9 , 12 months Observation,Rest pain relieve 3 ,6 , 9 , 12 months Observation

Secondary Outcome Measures

Name	Time	Method
Transcutaneous oxygen measurement 3,6,9,12 months Transcutaneous oxygen measurement, Ankle brachial index 3,6,9,12 months Ankle brachial index,Toe pressure Brachial index 3,6,9,12 months Toe pressure Brachial index