Comparison of the effect of autologous cell therapy with standard treatment in patients with diabetic foot

Phase 1

• Conditions: Autologous cell therapy (ACT) is new technique for patients with critical limb ischemia and diabetic foot (DF). In our study, the effect of ACT and also the repetitive treatment will be compared with standard treatment in DF patients ineligible for angioplasty. We suppose an enhanced effect of ACT on on macro- and microcirculation and improved limb outflow. Expected results of the project include improved tissue oxygenation, enhanced DF healing and a reduced risk of major amputation.; MedDRA version: 19.0Level: PTClassification code 10034576Term: Peripheral ischaemiaSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-001397-15-CZ
• Lead Sponsor: Institut klinické a experimentální medicíny

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-14
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

To include int the study the following criteria must be fullfilled:
1.diabetic foot disease (DFD; ulcer distal from ankle) or status after minor amputation, in accordance with international classification TEXAS 2-3 (C-D), Wagner 2-4
2.presence of chronic critical limb ischemia – ulcers or gangrene attributable to objectively proven arterial occlusive disease (transcutaneous oxygen pressure TcPO2 under 35 mm Hg), non-eligibility for standard revascularization (PTA or by-pass)
3.age 18-90 years
4.diabetes mellitus type 1 or 2
5.signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patients who fullfilled one of these criteria will be excluded:
1.severe active deep infection of DFD
2.deep vein thrombosis less than 6 months
3.severe limb oedema that rule out intramuscular injection of cell suspension
4.severe non-treated diabetic retinopathy requiring acutely a laser therapy
5.severe haematological disease
6.diagnosed neoplastic process of any organ
7.expected life prognosis shorter than 6 months
8.contracindication of general anestesia
9.females of childbearing potential must be willing to use a highly effective method of contraception (hormonal or barrier method of birth control; abstinence). Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the project is to compare the effect on tissue oxygenation and clinical outcome of autologous cell therapy with standard treatment in patients with diabetic foot disease (DFD) not eligible for PTA and to verify the effect of repetitive cell therapy. <br>;Secondary Objective: Other objectives of the project are quality of life assessment and side effects of study treatment. ;Primary end point(s): Comparison of cell therapy with standard treatment in several parameters:<br>a)Assessment of tissue oxygenation – improvement of parameters of ischemia (measured by transcutaneous oxygen pressure andoptionally by other angiological methods)<br>b)Clinical effect – wound healing, change in pain, rate of major amputation, amputation-free survival<br>;Timepoint(s) of evaluation of this end point: Transcutaneous oxygen pressure and other parameters will be assessed after 1, 3 and 6 months after the ACT.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Safety: adverse events - expected and unexpected <br>2.Assesment of study treatment by patients (psychological questionaries)<br>3.To assess the relation between the quality of cell suspension and tissue oxygenation <br>;Timepoint(s) of evaluation of this end point: Safety: during and up to 6 months after the procedure<br>Questionaries: after 1, 3 and 6 months after the procedure<br>Quality: directly after the procedure