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Completed

NCT Number: NCT03942250

Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients

To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in Epidermolysis Bullosa (EB) patients.

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Key information

Conditions

Epidermolysis Bullosa Chronic Skin Ulcer Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amniotic tissue lab

Cairo, 29, Egypt

About this study

Dried human amniotic membrane dressing were obtained from National center for radiation research and technology, Egypt (NCRRT), 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

1- Patients diagnosed as EB wounds must be chronic

Exclusion criteria

  • Patients Must stop other line of treatment
  • Exclude patients have:
  • Autoimmune diseases
  • Diabetes

Treatment and study plan

REGE pro dressing

Biological

REGE pro is a dressing of dried human amniotic membrane sterilized by gamma radiation

Primary outcomes

  1. Lesion area

    Time frame: 6 weeks

    The lesion area from the first treatment is greater than 2 cm^2 (grade 3, according to CTCAE v4.0), to the complete healing (= 0 cm^2).

  2. Clinical progression sings

    Time frame: 6 weeks

    • After the first application time: White transperent color of granulation tissue appeared.
    • After the second application time: color dense of granulation tissue increased and covered all over the wound.
    • After the third application time: granulation tissue thickness increased and appeared as a complete homogenous layer.
    • After the fourth application time: depending on lesion depth and size, granulation tissue turned to be pink to red color.
    • After the fifth and sexth application time: Skin layers development appeared.

Secondary outcomes

  1. Patient complain (upon the weekly questionnaire)

    Time frame: 6 weeks

    The quality of life is scored 0 (minimum) -100 (maximum), the pain reduction is scored 0-100 (as previous) from the first visit till 6 weeks.

Sponsors and collaborators

Lead sponsor

Egyptian Atomic Energy Authority

Other Gov

Collaborators

  • Waleed Nemr,Egyptian Atomic Energy Authority

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
May 8, 2019
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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