Stromal vascular fraction cells for the treatment of critical limb ischemia

Not Applicable

Completed

• Conditions: Critical limb ischemia; Circulatory System

• Registration Number: ISRCTN13001382
• Lead Sponsor: JSC Froceth

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28629476. This article was retracted on 18/02/2020 (see https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-020-02266-3 ).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-26
• Study Completion: 2018-01-01
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Smokers
2. Diabetic feet
3. Poor vascularisation of the limb
4. Prescribed amputation
5. Aged 18 years and over

Exclusion Criteria

1. Pregnancy
2. Age below 21

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain is measured using the visual analogue scale (VAS) at baseline, 24, 48 and 72 hours post multiple injections.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Neovascularisation process is measured using angiography at baseline, 2 weeks, 2, 6, 12 and 24 months<br> 2. Claudication index is assessed using a functional distance measurement test at baseline, 2 weeks, 2, 6, 12 and 24 months respectively<br>