Diabetes Mellitus Clinical Trial
Official title:
Microvascular Effect After the Application of Cell Therapy With a Hematopoietic Stem Cell Concentrate in Patients With Peripheral Arterial Disease With Non-critical Ischemia and Diabetes
This is a randomized controlled trial with blinding (for the observer who evaluates treatment
goals).
With two groups to study. A group of patients with conventional therapy for the treatment of
PAD (Platelet antiaggregant, statin, cilostazol in case of claudication) and the other group
of patients with conventional therapy for treatment of PAD plus cell therapy with objective
to evaluate the microvascular effect after the application of cell therapy with a
hematopoietic stem cell concentrate in patients with PAD with non-critical ischemia and
Diabetes. Perform evaluations of the microcirculation by means of TcPO2 at 30, 60, 90 and 180
days after the experimental maneuver (cell therapy) and conventional therapy.
INTRODUCTION: Peripheral arterial disease (PAD) is defined as arterial occlusion of the lower
extremities. Based on epidemiological studies using the Ankle-Brachial Index (ABI), the
prevalence of PAD (defined as an ABI <0.9) in diabetic patients ranges from 20% to 30%.
Diabetic patients with PAD have a higher mortality and death rate at a younger age than
patients without diabetes. The appropriate medical treatment for EAP in patients with
diabetes is based on the control of cardiovascular risk factors. Revascularization is
indicated in particular situations in PAD in the context of critical chronic ischemia (ABI
<0.6), however, anatomical factors, operative risk, technical difficulties or patient
preferences may limit its use in patients with PAD and diabetes. Therapeutic angiogenesis is
an experimental approach to restore perfusion and cell therapy can provide a continuous
source of growth factors and structural elements for therapeutic angiogenesis. The
transcutaneous oxygen pressure (TcPO2) is defined as a microvascular evaluation system. The
microvascular effect of cell therapy at an earlier stage of PAD has not been analyzed as
non-critical ischemia in patients with diabetes.
OBJECTIVE: To evaluate the microvascular effect after the application of cell therapy with a
concentrate of hematopoietic stem cell in patients with PAD with non-critical ischemia and
Diabetes.
MATERIAL AND METHODS: Randomized controlled clinical trial with blinding (for the observer
who evaluates treatment goals). With two groups for your study. A group of patients with
conventional therapy for the treatment of PAD (Platelet antiaggregant, statin, cilostazol in
case of claudication) and the other group of patients with conventional therapy for treatment
of PAD plus cell therapy, to be carried out in patients entitled to the Mexican Institute of
the Social Security of the Guanajuato Delegation, with diagnosis of Diabetes Mellitus type 2
of more than 10 years of detection and with diagnosis of peripheral arterial disease with an
ABI between 0.6 and 0.9 that agree to participate in the study. Cell therapy will consist of
hematopoietic progenitor cells identified as a fraction of cells identified by flow cytometry
as CD34 + obtained by peripheral blood harvesting procedure, prior mobilization process with
filgrastim.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A | |
Recruiting |
NCT03462420 -
Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes
|
N/A |