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

Not Applicable

Completed

• Conditions: Epidermolysis Bullosa; Chronic Skin Ulcer
• Interventions: Biological: REGE pro dressing

• Registration Number: NCT03942250
• Lead Sponsor: Egyptian Atomic Energy Authority

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2017-12
• Study First Submitted: 2018-02-22
• Study Completion: 2019-02
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-17
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treated	REGE pro dressing	Patients who received REGE pro dressing on EB wounds lesion weekly for 10 weeks

Primary Outcome Measures

Name	Time	Method
Lesion area	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).
Clinical progression sings	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 Outcome Measures

Name	Time	Method
Patient complain (upon the weekly questionnaire)	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.

Trial Locations

Locations (1)

Amniotic tissue lab; 🇪🇬 Cairo, Egypt