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NCT05135130 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

Official title:
A Retrospective Record-review Study in Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05135130
Other study ID # ON101CLOS01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 4, 2021
Est. completion date January 2022

Study information
Verified date November 2021
Source Oneness Biotech Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 176
Est. completion date January 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 79 Years
Eligibility No additional inclusion or exclusion criteria will be applied.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ON101 Cream
Not applicable in this retrospective study

Locations
Country Name City State
Taiwan China Medical University Hospital Taichung City

Sponsors (1)
Lead Sponsor Collaborator
Oneness Biotech Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Demographic characteristics Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial
Primary Wound characteristics of DFUs (classification and proportion) Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial
Primary 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after completing or withdrawing from the ON101CLCT02 trial Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial
Primary Medical costs due to DFUs Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial
Primary Proportion of wound infection, gangrene, and amputation Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial
Primary Frequency of wound infection, gangrene, and amputation Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial
See also
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Active, not recruiting NCT00389636 - TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers N/A
Completed NCT01181440 - Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers Phase 3
Enrolling by invitation NCT05888259 - Plantar Pressure Distribution in Diabetic Foot Ulcer N/A
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Completed NCT03312595 - Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) N/A
Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A