Using of Irradiated Amnion Dressing for the Treatment of Skin Ulcer

Completed

• Conditions: Ulcer

• Registration Number: NCT03440528
• Lead Sponsor: Egyptian Atomic Energy Authority

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2016-02-02
• Study First Submitted: 2017-12-30
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-22
• Primary Completion: 2018-09
• Study Completion: 2018-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-17
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• patients have unhealing ulcer

Exclusion Criteria

• must stop other line of treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Size of ulcer	2 week	REGE pro decreased size of ulcer after second treatment

Secondary Outcome Measures

Name	Time	Method
Reduction of pain	1 week	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.

Trial Locations

Locations (1)

Amniotic tissue lab; 🇪🇬 Cairo, Egypt