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Retrospective Record-review Study in Patients Who Had Diabetic Foot Ulcer

NCT ID: NCT05135130

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-04

Study Completion Date

2022-01-31

Brief Summary

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The purpose of the study is to evaluate the medical cost of illness for DFUs on the patients who had used ON101 or Aquacel® in the ON101CLCT02 trial.

Detailed Description

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Conditions

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Diabetic Foot Ulcer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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ON101 Cream

Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm

ON101 Cream

Intervention Type DRUG

Not applicable in this retrospective study

Aquacel® Hydrofiber® dressing

Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm

No interventions assigned to this group

Interventions

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ON101 Cream

Not applicable in this retrospective study

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

No additional inclusion or exclusion criteria will be applied.
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oneness Biotech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shyi-Gen Chen, MD

Role: STUDY_DIRECTOR

Oneness Biotech Co., Ltd.

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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ON101CLOS01

Identifier Type: -

Identifier Source: org_study_id