effect of alginate hydrogel dressing with stem cells and secretome in the treatment of resistant diabetic foot ulcers
- Conditions
- Diabetic foot ulcer.
- Registration Number
- IRCT20240513061768N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 90
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.