Comparison of the safety and efficacy of an alginate hydrogel dressing with placental-derived stem cells and an alginate hydrogel dressing with secretome in the treatment of diabetic foot ulcer resistant to standard treatment: a phase II clinical trial

Inclusion criteria:

Both male and female and over 18 years old Ability to refer to course visits Type 1 and 2 diabetes confirmed according to the guidelines of the American Diabetes Association The presence of at least one or more diabetic foot ulcers with a size of less than 15 cm in their greatest diameter or a severity level of less than two according to the Texas classification insulin or Drug therapy for control sugar Having informed consent to participate in a clinical trial

Exclusion criteria:

Any underlying disease that causes a change in the wound treatment process, such as cancer or immunodeficiency diseases Renal Failure that requires dialysis Degree of diabetic foot ulcer more than 2 based on Texas classification Wound infection that indicates osteomyelitis based on clinical and laboratory evidence Diagnosis of critical ischemia of the lower limbs that has been checked by Doppler ultrasound Necrosis in distal wound Pregnancy and breastfeeding Mental and psychological problems that prevent the patient from making an independent decision to participate in the study

Target sample size: 90