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

February 13, 2026 updated by: Oneness Biotech Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This ClinicalTrials.gov record exists that reports results for the ON101CLCT02 trial.(identifier: NCT01898923)

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 404
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The ON101CLCT02 trial enrolled 236 subjects and was conducted in Taiwan, China, and USA. The target population of this study consists of the Taiwanese DFU patients who had completed or early withdrawn from the ON101CLCT02 trial.

Description

No additional inclusion or exclusion criteria will be applied.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Characteristics: Weight (Mean)
Time Frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Demographic Characteristics: BP (Mean)
Time Frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Demographic Characteristics: ABI (Mean)
Time Frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The normal range for the ankle-brachial index is between 0.90 and 1.30. An index of 0.41 to 0.90 indicates mild to moderate arterial disease and an index of 0.40 and lower indicates severe disease. An index higher than 1.3 indicates stiff, non-compressible blood vessels which are common in diabetes. Left and right Ankle-Brachial Index (ABI) values are calculated by dividing the highest systolic pressure from each ankle (posterior tibial or dorsalis pedis artery) by the highest overall brachial (arm) systolic pressure.
Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Medical Costs Due to DFUs
Time Frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
The total medical cost due to diabetic foot ulcers across 140 participants is reported.
Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Percentage of Amputation
Time Frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Major amputations involve removing a limb above or through the ankle (e.g., below-knee/transtibial, above-knee/transfemoral), significantly impacting mobility. Minor amputations, such as toes or metatarsal, are distal to the ankle and aim to preserve function. Total amputations include the sum of major and minor amputations.
Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oneness Biotech Co., Ltd.

Investigators

  • Study Director: Shyi-Gen Chen, MD, Oneness Biotech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Actual)

January 20, 2022

Study Completion (Actual)

January 20, 2022

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ON101CLOS01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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