The use of stem cells loaded on nanofiber tissue scaffolds to repair the diabetic foot ulcer
Not Applicable
- Conditions
- Diabetic foot ulcer.Diabetes mellitus with peripheral circulatory complicationsE14.5
- Registration Number
- IRCT20190214042712N1
- Lead Sponsor
- Iran National Science Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Age 21 to 65 years old
Having diabetic foot wounds that have not recovered despite a cure during the past month (2-7 cm)
Feeling pain at rest and walking
Signature written consent
Exclusion Criteria
Patients over 65 years old
Pregnancy or breastfeeding
The presence of septicemia
Other systemic diseases in which the kidney is involved, such as cancer, autoimmune diseases, blood diseases, liver disease and ...
Hospitalization due to serious illness in the past two months
Severe malnutrition
The presence of foot ulcer due to all reasons except for diabetes, for example, syphilis, tuberculosis, or fungal foot
Any allergy to the compounds used in the cell culture process
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound size based on cm2. Timepoint: Before treatment and at every 1 and 2 weeks after treatment. Method of measurement: By multiplying the length of the wound by depth of the wounds.;The distance that the patient can walk without pain. Timepoint: Before treatment and at every 1 and 2 weeks after treatment. Method of measurement: Meter.;Biochemical markers including ALT, AST, Bilirubin, FBS, TG, Cholesterol, BUN, Cr. Timepoint: Before and after treatment. Method of measurement: Biochemical tests.
- Secondary Outcome Measures
Name Time Method