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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210422051040N2

Enrollment

Registered

2023-06-20

Start date

2023-05-22

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

diabetes. Diabetes mellitus due to underlying condition

Interventions

Intervention 1: Control group: Routine dressing. Intervention 2: Intervention group: Cellular and acellular amniotic membrane and, in the intervention group, amniotic dressing will be used for improve

Eligibility

Sex/Gender

All

Age

40 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Wound surface. Timepoint: 30 day. Method of measurement: Imaging of the wound surface.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHojjat Allah Abbaszadeh

Shahid Beheshti University of Medical Sciences

dr.abbaszadeh79@gmail.com+98 21 23872

Outcome results

None listed

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