Clincosm LogoSign in Get a demo

Using of Irradiated Amnion Dressing for the Treatment of Skin Ulcer

Sponsor
Egyptian Atomic Energy Authority (Other)
Overall Status
Completed
CT.gov ID
NCT03440528
Collaborator
(none)
3
Enrollment
1
Location
31.9
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Using of Irradiated Amnion Dressing for the Treatment of Skin Ulcer
    Actual Study Start Date :
    Feb 2, 2016
    Actual Primary Completion Date :
    Sep 1, 2018
    Actual Study Completion Date :
    Oct 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Size of ulcer [2 week]

      REGE pro decreased size of ulcer after second treatment

    Secondary Outcome Measures

    1. 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.

    Other Outcome Measures

    1. Complete curring [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 [10 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients have unhealing ulcer
    Exclusion Criteria:
    • must stop other line of treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Amniotic tissue lab Cairo Egypt 29

    Sponsors and Collaborators

    • Egyptian Atomic Energy Authority

    Investigators

    • Study Director: Nashwa K Radwan, PhD, NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nashwa Radwan, Lecture of Dermatology, Egyptian Atomic Energy Authority
    ClinicalTrials.gov Identifier:
    NCT03440528
    Other Study ID Numbers:
    • 29112017NCRRT
    First Posted:
    Feb 22, 2018
    Last Update Posted:
    Jun 27, 2019
    Last Verified:
    Jun 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nashwa Radwan, Lecture of Dermatology, Egyptian Atomic Energy Authority
    Skin ulcer, Human amniotic membrane, Treatment
    Additional relevant MeSH terms:
    Skin Ulcer
    Ulcer

    Study Results

    No Results Posted as of Jun 27, 2019