ClinicalTrials.gg
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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Ulcer with a site in Egypt — 4 open to participants now, 4 under way, 1 of them phase 3. Ulcer · Egypt.

Started
2016
with 1 other
Observational
2 of 22
none open now
Registered
5th of 22
by date
Lead sponsor
1 of 22
Egyptian Atomic Energy Authority

Among the 22 studies in Ulcer with a site in Egypt, this one is one of 2 that started in 2016, is one of 2 observational ones, and was the 5th registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

No phase14 · 2 open
Observationalthis study2 · 0 open
Phase 22 · 1 open
Phase 32 · 0 open
Phase 2/31 · 1 open
Phase 41 · 0 open

By the year they started

First in 2012; this study’s year is marked. 2 started in 2016.

Size and results

Median enrollment 38 across the 20 interventional studies, 72 across the 2 observational. Of the 13 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 22 studies in Ulcer with a site in Egypt, or all of them as a file.
02

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.

03

Conditions studied

  • Ulcer

Browse trials for

Keywords

  • Skin ulcer, Human amniotic membrane, Treatment
04

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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients have unhealing ulcer

Exclusion criteria

Exclusion Criteria:

  • must stop other
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
3 participants (actual)
Patient registry
No
06

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

07

Study locations

1 site
  • Amniotic tissue lab
    Cairo, 29, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2016 to primary completion in Sep 2018, 31 months.

Of 22 observational studies under Ulcer, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 78. This study's 31 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2017
First posted
Feb 22, 2018
StartActual
Feb 2, 2016
Primary completionActual
Sep 2018
CompletionActual
Oct 2018
Last update
Sep 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

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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Discussion

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