Investigating the effectiveness of using cellular and acellular amniotic membrane in the treatment of foot ulcers in patients with diabetes: Phase 1 and 2 randomized clinical trial
Phase 1
Recruiting
- Conditions
- diabetes.Diabetes mellitus due to underlying condition
- Registration Number
- IRCT20210422051040N2
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
The presence of diabetic foot ulcer criteria
The wound area is more than 2 cm2 and less than 5 cm2
The patient does not have HIV, HBV, HCV, HTLV1 viral infections
The patient does not have an acute bacterial infection
Adherence to medication regimen by diabetic patients
Exclusion Criteria
Abuse of drugs and alcohol
Acute bacterial infection and sepsis
Cancer and use of cytotoxic drugs
Severe vascular diseases, lupus, rheumatoid arthritis, kidney failure
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound surface. Timepoint: 30 day. Method of measurement: Imaging of the wound surface.
- Secondary Outcome Measures
Name Time Method