Using of Irradiated Amnion Dressing for the Treatment of Skin Ulcer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03440528

Enrollment

Registered

2018-02-22

Start date

2016-02-02

Completion date

2018-10-31

Last updated

2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcer

Keywords

Skin ulcer, Human amniotic membrane, Treatment

Brief summary

To evaluate the using of a commercial product of dried human amniotic membrane sterilized by gamma irradiation for the treatment of skin ulcer.

Detailed description

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* patients have unhealing ulcer

Exclusion criteria

* must stop other line of treatment

Design outcomes

Primary

Measure	Time frame	Description
Size of ulcer	2 week	REGE pro decreased size of ulcer after second treatment

Secondary

Measure	Time frame	Description
Reduction of pain	1 week	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.

Other

Measure	Time frame	Description
Complete curring	4 to 10 weeks	REGE pro healed ulcer after 4 to 10 weeks. The improvement of ulcer was observed by photographs taken before and each week post application.
Freedom from scarring	10 weeks	It was observed that the using of REGE pro prevent any scar formation in all applied patients.

Countries

Egypt

Outcome results