Retrospective Record-review Study in Patients Who Had Diabetic Foot Ulcer
Sponsor
Oneness Biotech Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05135130
Collaborator
(none)
176
1
2.9
60.2
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
176 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
A Retrospective Record-review Study in Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial
Actual Study Start Date
:
Oct 4, 2021
Anticipated Primary Completion Date
:
Dec 1, 2021
Anticipated Study Completion Date
:
Jan 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ON101 Cream Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm |
Drug: ON101 Cream
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 |
Outcome Measures
Primary Outcome Measures
- Demographic characteristics [Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial]
- Wound characteristics of DFUs (classification and proportion) [Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial]
- Proportion of DFU recurrence after completing or withdrawing from the ON101CLCT02 trial [Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial]
- Medical costs due to DFUs [Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial]
- Proportion of wound infection, gangrene, and amputation [Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial]
- Frequency of wound infection, gangrene, and amputation [Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
No additional inclusion or exclusion criteria will be applied.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China Medical University Hospital | Taichung City | Taiwan | 404 |
Sponsors and Collaborators
- Oneness Biotech Co., Ltd.
Investigators
- Study Director: Shyi-Gen Chen, MD, Oneness Biotech Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Oneness Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05135130
Other Study ID Numbers:
- ON101CLOS01
First Posted:
Nov 26, 2021
Last Update Posted:
Dec 8, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: