Safety evaluation of amniotic membrane extract in management of the diabetic foot ulcers
- Conditions
- Diabetic foot ulcer.
- Registration Number
- IRCT20180102038195N1
- Lead Sponsor
- Iranian academic center for education culture and research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
Age 18 or older
To be able and willing to provide consent letter and agree to comply with study procedures and follow-up evaluations
Ulcer size>1 and <36 cm2
Ulcer duration of =4weeks
No clinical signs of infection
Serum creatinine<3·0 mg/dl
Glycosylated haemoglobin (HbA1c)<12%
Adequate circulation
Ankle-brachial index (ABI) between 0·7 and 1·2 or having e a normal Doppler arterial
participating in another clinical trial
Currently receiving radiation or chemotherapy
known or suspected malignancy of current ulcer
Diagnosis of autoimmune connective tissue disease
Received a biomedical or topical growth factor for their wound within the previous 30 days
Pregnant or breast feeding
Sensitivity to drug uses
Smoking and drug abuse
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Side effectes. Timepoint: Every week. Method of measurement: Common Terminology Criteria for Adverse Events.;Wound healing rate. Timepoint: Every week. Method of measurement: AutoCAD software.
- Secondary Outcome Measures
Name Time Method