IRCT20240317061316N1
Recruiting
Phase 1
Evaluation of safety and efficacy of using exosome harvested from human umbilical cord mesenchymal stem cells (hucMSCs) in diabetic foot ulcer patients (Clinical trial Phases I,II)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Diabetic Foot Ulcer.
- Sponsor
- Qazvin University of Medical Sciences
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntary participation in the research by complying with the requirements of the protocol and accepting the steps related to its implementation and signing the informed consent form
- •Age over 30 years and less than 60 years
- •Suffering from type I or type II diabetes
- •Diabetic foot ulcer size between 1 cm2 to 12 cm2
- •Type II or type III wound with Wagner grading and spread to skin, tendon and subcutaneous tissue without evidence of active wound infection at the time of eligibility to participate in the study
- •Free of necrotic remnants in the target wound
- •Blood glycosylated hemoglobin level (HbA1c) \<\=10%
- •Satisfactory perfusion to the wound as confirmed by measurement of systolic blood pressure in the posterior or anterior tibial artery (\>50 mmHg) of the affected limb
- •General health status, which according to the researcher, allows the patient to participate in all stages of the study
Exclusion Criteria
- •1\. Non\-diabetic pathophysiological wound.
- •2\. People who need intravenous (IV) antibiotics to treat infection.
- •3\. Current evidence of infection, including drainage of pus from the wound site.
- •4\. People with severe kidney failure who cannot be managed with kidney dialysis.
- •5\. People with severe liver failure.
- •6\. Human immunodeficiency virus (HIV) positive
- •7\. People who have an allergic reaction or hypersensitivity to natural proteins and polysaccharides.
- •8\. Pregnancy or breastfeeding
- •9\. People with a clinical history related to alcohol or drug abuse.
- •10\. Suffering from a disease that can affect the study.
Outcomes
Primary Outcomes
Not specified
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