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Completed

NCT Number: NCT03440528

Using of Irradiated Amnion Dressing for the Treatment of Skin Ulcer

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

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Key information

Conditions

Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Amniotic tissue lab

Cairo, 29, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients have unhealing ulcer

Exclusion criteria

  • must stop other line of treatment

Treatment and study plan

Primary outcomes

  1. Size of ulcer

    Time frame: 2 week

    REGE pro decreased size of ulcer after second treatment

Secondary outcomes

  1. Reduction of pain

    Time frame: 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.

Other outcomes

  1. Complete curring

    Time frame: 4 to 10 weeks

    REGE pro healed ulcer after 4 to 10 weeks. The improvement of ulcer was observed by photographs taken before and each week post application.

  2. Freedom from scarring

    Time frame: 10 weeks

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

Sponsors and collaborators

Lead sponsor

Egyptian Atomic Energy Authority

Other Gov

Collaborators

  • Waleed Nemr,Egyptian Atomic Energy Authority

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 22, 2018
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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