Evaluation of efficacy and safety of dermal substitute (Sinaderm)

Phase 3

• Conditions: Personal history of diabetic foot ulcer.; Personal history of diabetic foot ulcer; Z86.31

• Registration Number: IRCT20190210042676N7
• Lead Sponsor: SinaCell Knowledge-based production Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 68

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area of ??wound compared to baseline. Timepoint: Before the intervention and once a week for 8 weeks. Method of measurement: Checkered paper.

Secondary Outcome Measures

Name	Time	Method
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).