Personal history of diabetic foot ulcer. Personal history of diabetic foot ulcer
Conditions
Interventions
Intervention 1: Intervention group: human fibroblast-derived dermal substitute(sinaderm) plus wet dressing. sinaderm will be inserted once or twice according to physician opinion and wet dressing will
Sponsors
SinaCell Knowledge-based production Company
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Signing the consent form for participation in the study Men or women with type I or II diabetes mellitus and neuropathy disorder 3 (defined by Michigan diabetic neuropathy score) At least 1, but no more than 2, partial thickness neuropathic ulcer (stage I and II as defined by Wagner staging system) located on the lateral foot, plantar arch, forefoot, , heel, or toe The target ulcer have an area, after debridement between 3 and 25 cm2 The target ulcer has been present for at least 4 weeks at the time of the baseline visit
Exclusion criteria
Exclusion criteria: Patients with ulcers resulting from electrical, chemical, or radiation burns or venous insufficiency Patients with ulcers resulting from amputation Uncontrolled infection or necrosis or cellulitis at the site of the target ulcer Chronic renal insufficiency (serum creatinine > 2.5) Uncontrolled hyperglycemia (HbA1c > 10%) Administration of some medications (chemotherapy, immune suppressants, corticosteroids or radiotherapy) within past 30 days Pregnancy or lactating Heavy smokers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area of ??wound compared to baseline. Timepoint: Before the intervention and once a week for 8 weeks. Method of measurement: Checkered paper. | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients who responded 50% to treatment. Timepoint: Once a week for 8 weeks. Method of measurement: counting the respounders.;Patients' satisfaction. Timepoint: Once a week for 8 weeks. Method of measurement: Questionnaire.Patent will declare his or her satisfaction in case of the compatibility of the dressings , its help to reduce the pain and also improving the wound using five-grade Likert scale (5= extremely satisfied, 4= very satisfied, 3= moderately satisfied, 2= slightly satisfied, 1= dissatisfied). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAniseh Samadi
Tehran University of Medical Sciences
Outcome results
None listed