Diabetic foot ulcer.
Conditions
Interventions
Intervention 1: Control group: Receiving standard treatments and silicone dressing with alginate. Intervention 2: first intervention group: Receiving standard treatments and silicone dressing along wi
Sponsors
Tehran University of Medical Sciences
Zist bioregeneration company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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 Less than 20% reduction in wound area during the two weeks prior to randomization
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Epithelialization percent. Timepoint: Epithelization percentage assessment at the beginning of the study (before the intervention) 15, 30, 45, 60, 75 and 90 days after the application of the patches. Method of measurement: graduated ruler. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of local and systemic conditions. Timepoint: 15, 30, 45, 60, 75 and 90 days after the application of the patches. Method of measurement: Clinical and paraclinical observation.;Healing of the ulcer time. Timepoint: 15, 30, 45, 60, 75 and 90 days after the application of the patches. Method of measurement: Clinical observation.;Ulcer reduction percentage. Timepoint: 15, 30, 45, 60, 75 and 90 days after the application of the patches. Method of measurement: graduated ruler.;Ulcer infection percentage. Timepoint: 15, 30, 45, 60, 75 and 90 days after the application of the patches. Method of measurement: Clinical and paraclinical observation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMojtaba Sarvestani
Taskin Bioregeneration
Outcome results
None listed