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

An observational study of Diabetic Foot Ulcer, run by Oneness Biotech Co., Ltd. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 20 to 79 years
Conditions the study is for: Diabetic Foot Ulcer
What is being tested?: ON101 Cream
How many people: 160 participants
Where: 1 siteTaiwan
Study dates: 4 Oct 2021to 20 Jan 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

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 The target population of this study consists of the Taiwanese DFU patients who had completed or early withdrawn from the ON101CLCT02 trial.

No additional inclusion or exclusion criteria will be applied.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

China Medical University Hospital
Taichung, 404

Other trials in Taiwan

About this study

Official title: 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.

Read the detailed description

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

Conditions: Diabetic Foot Ulcer
Being tested: ON101 Cream
Medical subject headings: Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ON101 CreamDrug
Not applicable in this retrospective study

Study groups in NCT05135130
Study group	Role	What they receive
ON101 Cream		Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm Receives: Drug: ON101 Cream
Aquacel® Hydrofiber® dressing		Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm

What is being measured

The primary outcome is the main question the study is designed to answer.

Demographic Characteristics: Weight (Mean)
Measured: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Demographic Characteristics: BP (Mean)
Measured: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Demographic Characteristics: ABI (Mean)
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.
Measured: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Medical Costs Due to DFUs
The total medical cost due to diabetic foot ulcers across 140 participants is reported.
Measured: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Percentage of Amputation
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.
Measured: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 202120 Jan 2022

First posted26 Nov 2021
Study start4 Oct 2021
Primary completion20 Jan 2022
Study completion20 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05135130
Sponsor's protocol ID: ON101CLOS01
Status last verified: Feb 2026
First submitted: 16 Nov 2021
Last updated: 6 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

All Diabetic Foot Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective Record-review Study in Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial
ClinicalTrials.gov ID: NCT05135130
Acronym / sponsor ID: ON101CLOS01
Conditions: Diabetic Foot Ulcer
Study type: Observational
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Oneness Biotech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 4 Oct 2021 (actual)
Primary completion: 20 Jan 2022 (actual)
Study completion: 20 Jan 2022 (actual)
First posted: 26 Nov 2021 (actual)
Results: Posted 6 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
ON101 Cream	–	Drug: ON101 CreamPatients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm
Aquacel® Hydrofiber® dressing	–	–Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm

Who may qualify

Ages: 20 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ON101 CreamNot applicable in this retrospective study	Drug	ON101 Cream

Primary outcome

Demographic Characteristics: Weight (Mean)
Time frame: 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.
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.
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.
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.

Results and safety

Results posted to the registry on 6 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ON101 Cream	81	81
Aquacel® Hydrofiber® Dressing	79	79

Primary outcome: Demographic Characteristics: Weight (Mean)

Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.. Mean (Standard Deviation). Unit: kg

Measure	ON101 Cream n = 81	Aquacel® Hydrofiber® Dressing n = 79
Value	73.7 (15.0)	78.3 (17.3)

Primary outcome: Demographic Characteristics: BP (Mean)

Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.. Mean (Standard Deviation). Unit: mmHg

Measure	ON101 Cream n = 81	Aquacel® Hydrofiber® Dressing n = 79
SBP	132 (25.2)	144 (27.6)
DBP	74.8 (14.3)	77.4 (14.2)

Primary outcome: Demographic Characteristics: ABI (Mean)

Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.. Mean (Standard Deviation). Unit: ABI

Measure	ON101 Cream n = 81	Aquacel® Hydrofiber® Dressing n = 79
Left ABI	1.1 (0.1)	1.0 (0.2)
Right ABI	0.9 (0.2)	1.1 (0.1)

Primary outcome: Medical Costs Due to DFUs

Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.. Mean (Standard Deviation). Unit: NTD

Measure	ON101 Cream n = 71	Aquacel® Hydrofiber® Dressing n = 69
Value	19852.0 (25840.2)	25671.9 (31365.4)

Population analysed: Due to the retrospective nature of this study, certain clinical records were found to be incomplete. Consequently, the statistical analysis of healthcare expenditures was restricted to a subset of 140 patients (71 patients in the ON101 group and 69 patients in the Aquacel group) for whom comprehensive financial and medical data were available, ensuring the accuracy and reliability of the reported results.

Adverse events

Time frame: N/A. Adverse Events were not monitored/assessed in this retrospective study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ON101 Cream	0 of 0	0 of 0	0
Aquacel® Hydrofiber® Dressing	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Foot Ulcer

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shyi-Gen Chen, MD study director

Oneness Biotech Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Foot Ulcer, run by Oneness Biotech Co., Ltd. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographic Characteristics: Weight (Mean) (time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05135130.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.