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Safety evaluation of amniotic membrane extract in management of the diabetic foot ulcers

Safety evaluation of amniotic membrane extract in management of the diabetic foot ulcers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180102038195N1
Enrollment
10
Registered
2018-08-16
Start date
2018-07-25
Completion date
Unknown
Last updated
2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic foot ulcer.

Interventions

Use of amniotic membrane extract in the treatment of diabetic foot ulcers.

Sponsors

Iranian academic center for education culture and research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahin Jamshidi

Iran University of Medical Sciences

mahinjamshidi42@gmail.com+98 21 8893 6974

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026