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Lyophilized human amniotic membrane; a dressing for chronic diabetic foot wound healing

Evaluation of the efficacy of lyophilized human amniotic membrane as a dressing on chronic diabetic foot wound healing

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190131042570N1
Enrollment
18
Registered
2019-12-28
Start date
2020-01-10
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

Diabetic foot ulcer. E11

Interventions

Intervention 1: Intervention group: hydro-gel containing lyophilized human amniotic membrane, dress every 2 or 3 days, 3 or 4 times. Intervention 2: Control group: sterilized hydro-gel, dress every 2

Sponsors

Stem Cell and Regenerative Medicine Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 55 Years

Inclusion criteria

Inclusion criteria: patient with chronic diabetic foot HbA1C<8 ulcer duration less than one year having dorsalis pedis and posterior tibialis pulses Ulcer size =1 cm2 and < 25 cm2 No clinical signs of infection

Exclusion criteria

Exclusion criteria: other therapies in the last three months immunocompromised patient patients with history of allergy or hemostasis disorders Pregnant or breast feeding received corticosteroids or immunosuppresive drugs in the last six months smoking cigarette Known or suspected malignancy of current ulcer

Design outcomes

Primary

MeasureTime frame
Ulcer size. Timepoint: at baseline, in 1 week, 2 weeks, 4 weeks and 6 weeks. Method of measurement: by ruler.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAida Rezaei Nejad

The Stem Cell and Regenerative Medicine Research Center

aidarezaeen@yahoo.com00982161111

Outcome results

None listed

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