Diabetic Foot Ulcers. Type 1 diabetes mellitus with circulatory complications
Conditions
Interventions
Intervention 1: Intervention Group 1: Participants with Grade 2 diabetic foot ulcers who will receive exosomes derived from placenta-derived mesenchymal stem cells (MSCs) for the treatment of diabetic
Sponsors
Omid cell and tissue tech
Tehran University of Medical Sciences
Tarbiat Modares University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Providing a signed and dated informed consent form declaring willingness to comply with all study methods and being available throughout the study period male or female age greater than or equal to 18 years diagnosis of type 1 or 2 diabetes grade II diabetic foot ulcer based on the Wagner and Texas diabetic ulcer classification system non-ischemic and non-infected ulcers TpO2= 30 mmHg or ABI (Ankle Brachial Index) = 0.70 wounds that have not healed with good, standard care within 4 weeks prior to initiation of exosome treatment (reduction in wound area of less than 20% compared to baseline). If there is more than one wound, the investigator should select an index wound for treatment (usually the largest wound). Other wounds will receive standard care and will not be included in the study. A maximum of 2 wounds are permitted on the study leg An orthopedic evaluation must be completed to rule out a mechanical source of the wound. women of childbearing age must have a negative urine pregnancy test before the start of the study HbA1c level = 7-9% (controlled diabetes) for women of childbearing potential: use of highly effective contraception for at least 1 month before screening and agreement to use such a method throughout study participation.)
Exclusion criteria
Exclusion criteria: Clear indication for surgery (vascular reconstruction or skin grafting) Wound with exposed bone or tendon Bone involvement (X-ray images) Patients with 3 or more wounds on one leg Osteomyelitis Clinical signs of infection in the wound under study Patients with necrosis in the wound that cannot be removed by debridement at week 0. Patients with methicillin-resistant Staphylococcus aureus (MRSA) in the specific wound treated in the study Malnutrition: albumin less than 2.5 g/dL Wounds caused by electrical, chemical, radiation burns Pregnancy or lactation. Pregnant or lactating female patients Female patients of childbearing age who agree to use an acceptable method of contraception during the study, provided that they are not pregnant or breastfeeding. Presence of an infected diabetic foot ulcer with a grade greater than 1 according to the Diabetic Foot Ulcer Classification System (PEDIS) as diagnosed by clinical examination. Participation in any other clinical trial or currently receiving any other investigational product(s) within 30 days prior to study treatment Severe renal failure is defined as eGFR < 30 ml/min. Patients undergoing hemodialysis. Clinical diagnosis of peripheral vascular disease (PVD) requiring neovascularization. Limb ischemia requiring revascularization or imminent amputation History of peripheral vascular repair within 4 weeks prior to randomization Any planned surgery during the study period, including planned amputation at the site of the wound. Diagnosis of severe medical conditions such as severe heart failure or severe liver disease, according to the investigator's judgment, or the presence of a comorbidity that indicates a short life expectancy. Current diagnosis of cancer Current diagnosis of autoimmune disorders Individuals with immunosuppression Patients with immunodeficiency diseases, hepatitis, or active tuberculosis. Bleeding disorders, hemophilia, sickle cell disease, thrombocytopenia, and blood dyscrasias History of any medical or psychiatric condition that, in the opinion of the investigator, may increase the risks associated with participation in the study or administration of the investigational product(s). Patient known to have mental, developmental, physical, emotional, or social disorders or other illnesses that may interfere with the requirements of the study. Hemoglobin level less than 8 g/dL in men and less than 7 in women Platelet count less than 140,000 in platelet donors Current treatment for malignancy or neoplastic disease or sclera collagen disease Patients with ulcers from other causes (e.g., arterial insufficiency) The patient has a highly contagious disease or diseases that may limit follow-up. Current use of steroids or high-dose immunosuppressive drugs. Febrile illness within one month of examination Smokers History of alcohol or drug abuse in the past year before randomization Blood pressure higher than 100/180 or heart rate higher than 100 bpm or respiratory rate higher than 30 In case of wound progression and no healing process, exosome injection will be stopped and the patient will be excluded from the study. Failure to cooperate in the screening period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of Clinical Complications. Timepoint: 1 hour, 24 hours, 48 and 72 hours and 1 week after injection. Method of measurement: Clinical examinations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Absence of Secondary Clinical Complications. Timepoint: 7, 14, 21, 28 days and 3 months after injection. Method of measurement: Clinical Trials.;Skin Edema. Timepoint: 7, 14, 21, 28 days. Method of measurement: Reduction of swelling and fluid accumulation in the skin with a grading system often used to determine the severity of skin edema on a scale of +1 to +4. It is assessed by applying pressure to the affected area and then measuring the depth of the indentation (with a ruler) and the duration of its persistence (return time). Grade +1 to 2 mm indentation, determining the time to return using a timer.;Infection. Timepoint: 7, 14, 21, 28 days. Method of measurement: Bacterial Culture. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMasoud Soleimani
Omid Cell and Tissue Tech
Outcome results
None listed