IRCT20180102038195N1
Completed
未知
Safety evaluation of amniotic membrane extract in management of the diabetic foot ulcers
Iranian academic center for education culture and research0 sites10 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Iranian academic center for education culture and research
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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