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CompletedNCT03440528Updated Sep 21, 2023

Using of Irradiated Amnion Dressing for the Treatment of Skin Ulcer

An observational study in Ulcer, sponsored by Egyptian Atomic Energy Authority. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Egyptian Atomic Energy Authority · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
3
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Ulcer

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Keywords

  • Skin ulcer, Human amniotic membrane, Treatment
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

This study is based on randomized selection of 3 types of ulcer ( diabetic foot ulcer, post operative ulcer and ultrasonic ulcer)

Inclusion criteria

  • patients have unhealing ulcer

Exclusion criteria

Exclusion Criteria:

  • must stop other line of treatment
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
3 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Size of ulcer

    REGE pro decreased size of ulcer after second treatment

    Time frame: 2 week

Secondary outcomes

  1. 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.

    Time frame: 1 week

Other outcomes

  1. 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.

    Time frame: 4 to 10 weeks

  2. Freedom from scarring

    It was observed that the using of REGE pro prevent any scar formation in all applied patients.

    Time frame: 10 weeks

06

Study locations

1 site
  • Amniotic tissue lab
    Cairo, 29, Egypt
07

Registry details

Key details

Study ID
NCT03440528
Lead sponsor
Egyptian Atomic Energy Authority
Collaborators
Waleed Nemr,Egyptian Atomic Energy Authority
Responsible party
Nashwa Radwan (Lecture of Dermatology, Egyptian Atomic Energy Authority) — Principal investigator
First posted
Feb 22, 2018
Start date
Feb 2, 2016
Primary completion
Sep 2018
Completion
Oct 2018
Last update
Sep 21, 2023

Study contacts

Nashwa K Radwan, PhD
study director · NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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