NCT03440528

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2.6 years

First QC Date

December 30, 2017

Last Update Submit

September 17, 2023

Conditions

Ulcer

Keywords

Skin ulcer, Human amniotic membrane, Treatment

Outcome Measures

Primary Outcomes (1)

  • Size of ulcer

    REGE pro decreased size of ulcer after second treatment

    2 week

Secondary Outcomes (1)

  • Reduction of pain

    1 week

Other Outcomes (2)

  • Complete curring

    4 to 10 weeks

  • Freedom from scarring

    10 weeks

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study is based on randomized selection of 3 types of ulcer ( diabetic foot ulcer, post operative ulcer and ultrasonic ulcer)

You may qualify if:

  • patients have unhealing ulcer

You may not qualify if:

  • must stop other line of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amniotic tissue lab

Cairo, 29, Egypt

Location

MeSH Terms

Conditions

UlcerSkin Ulcer

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nashwa K Radwan, PhD

    NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecture of Dermatology

Study Record Dates

First Submitted

December 30, 2017

First Posted

February 22, 2018

Study Start

February 2, 2016

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

EG(1)