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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 September 2023
• Main ID: NCT03942250
• Date of registration: 22/02/2018
• Prospective Registration: No
• Primary sponsor: Egyptian Atomic Energy Authority
• Public title: Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients
• Scientific title: Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients
• Date of first enrolment: January 2017
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03942250
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Egypt

Contacts

• Name: Nashwa K Radwan, PhD
• Affiliation: NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY

Key inclusion & exclusion criteria

Inclusion Criteria:

1- Patients diagnosed as EB wounds must be chronic

Exclusion Criteria:

1. Patients Must stop other line of treatment

2. Exclude patients have:

1. Autoimmune diseases

2. Diabetes



Age minimum: 12 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Skin Ulcer

Epidermolysis Bullosa

Intervention(s)

Biological: REGE pro dressing

Primary Outcome(s)

Lesion area [Time Frame: 6 weeks]

Clinical progression sings [Time Frame: 6 weeks]

Secondary Outcome(s)

Patient complain (upon the weekly questionnaire) [Time Frame: 6 weeks]

Secondary ID(s)

2222018NCRRT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Waleed Nemr,Egyptian Atomic Energy Authority