Ulcer Clinical Trial
Official title:
Using of Irradiated Amnion Dressing for the Treatment of Skin Ulcer
| NCT number | NCT03440528 |
| Other study ID # | 29112017NCRRT |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 2, 2016 |
| Est. completion date | October 2018 |
| Verified date | September 2023 |
| Source | Egyptian Atomic Energy Authority |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
To evaluate the using of a commercial product of dried human amniotic membrane sterilized by gamma irradiation for the treatment of skin ulcer.
| Status | Completed |
| Enrollment | 3 |
| Est. completion date | October 2018 |
| Est. primary completion date | September 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - patients have unhealing ulcer Exclusion Criteria: - must stop other line of treatment |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Amniotic tissue lab | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Egyptian Atomic Energy Authority | Waleed Nemr,Egyptian Atomic Energy Authority |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Complete curring | REGE pro healed ulcer after 4 to 10 weeks. The improvement of ulcer was observed by photographs taken before and each week post application. | 4 to 10 weeks | |
| Other | Freedom from scarring | It was observed that the using of REGE pro prevent any scar formation in all applied patients. | 10 weeks | |
| Primary | Size of ulcer | REGE pro decreased size of ulcer after second treatment | 2 week | |
| Secondary | Reduction of pain | 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. | 1 week |
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