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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03440528
Other study ID # 29112017NCRRT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2, 2016
Est. completion date October 2018

Study information

Verified date September 2023
Source Egyptian Atomic Energy Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate the using of a commercial product of dried human amniotic membrane sterilized by gamma irradiation for the treatment of skin ulcer.


Description:

Dried human amniotic membrane patches were obtained from National center for radiation research and technology, Egypt, under commercial name REGE pro.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date October 2018
Est. primary completion date September 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients have unhealing ulcer Exclusion Criteria: - must stop other line of treatment

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Amniotic tissue lab Cairo

Sponsors (2)

Lead Sponsor Collaborator
Egyptian Atomic Energy Authority Waleed Nemr,Egyptian Atomic Energy Authority

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Complete curring REGE pro healed ulcer after 4 to 10 weeks. The improvement of ulcer was observed by photographs taken before and each week post application. 4 to 10 weeks
Other Freedom from scarring It was observed that the using of REGE pro prevent any scar formation in all applied patients. 10 weeks
Primary Size of ulcer REGE pro decreased size of ulcer after second treatment 2 week
Secondary Reduction of pain Patients response revealed reduction of pain at the time of application. One week post application, a questionnaire were collected from patients; about 95% of them ensured that pain was controlled. 1 week
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