An interventional study of REGE pro dressing in Epidermolysis Bullosa and Chronic Skin Ulcer, sponsored by Egyptian Atomic Energy Authority. Completed at 1 site in Egypt. Open to participants aged 12 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Egyptian Atomic Energy Authority · Not applicable, Interventional, and Treatment
To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in Epidermolysis Bullosa (EB) patients.
Dried human amniotic membrane dressing were obtained from National center for radiation research and technology, Egypt (NCRRT), under commercial name REGE pro.
1- Patients diagnosed as EB wounds must be chronic
Exclusion Criteria:
Exclude patients have:
Patients who received REGE pro dressing on EB wounds lesion weekly for 10 weeks
Biological: REGE pro dressing
REGE pro is a dressing of dried human amniotic membrane sterilized by gamma radiation
Lesion area
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).
Time frame: 6 weeks
Clinical progression sings
* 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.
Time frame: 6 weeks
Patient complain (upon the weekly questionnaire)
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.
Time frame: 6 weeks
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Egyptian Atomic Energy Authority