An observational study in Diabetic Foot Ulcer, sponsored by Oneness Biotech Co., Ltd.. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Oneness Biotech Co., Ltd. · Observational
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.
This ClinicalTrials.gov record exists that reports results for the ON101CLCT02 trial.(identifier: NCT01898923)
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 160 is above the median of 100 across 186 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Oneness Biotech Co., Ltd. is the lead sponsor of 20 studies on the registry; 4 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
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 The target population of this study consists of the Taiwanese DFU patients who had completed or early withdrawn from the ON101CLCT02 trial.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.
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm
Drug: ON101 Cream
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm
Not applicable in this retrospective study
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Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.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Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.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)
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
| Milestone | ON101 Cream | Aquacel® Hydrofiber® Dressing |
|---|---|---|
| Started | 81 | 79 |
| Completed | 81 | 79 |
| Not completed | 0 | 0 |
| kg | ON101 Cream | Aquacel® Hydrofiber® Dressing |
|---|---|---|
| Demographic Characteristics: Weight (Mean) | 73.7 ± 15.0 | 78.3 ± 17.3 |
| mmHg | ON101 Cream | Aquacel® Hydrofiber® Dressing |
|---|---|---|
| SBP | 132 ± 25.2 | 144 ± 27.6 |
| DBP | 74.8 ± 14.3 | 77.4 ± 14.2 |
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.
| ABI | ON101 Cream | Aquacel® Hydrofiber® Dressing |
|---|---|---|
| Left ABI | 1.1 ± 0.1 | 1.0 ± 0.2 |
| Right ABI | 0.9 ± 0.2 | 1.1 ± 0.1 |
The total medical cost due to diabetic foot ulcers across 140 participants is reported.
| NTD | ON101 Cream | Aquacel® Hydrofiber® Dressing |
|---|---|---|
| Medical Costs Due to DFUs | 19852.0 ± 25840.2 | 25671.9 ± 31365.4 |
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.
| Participants | ON101 Cream | Aquacel® Hydrofiber® Dressing |
|---|---|---|
| Major amputation | 0.00 | 1 |
| Minor amputation | 1 | 2 |
| Total amputation | 1 | 3 |
Collected over N/A. Adverse Events were not monitored/assessed in this retrospective study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ON101 Cream | — | — | — |
| Aquacel® Hydrofiber® Dressing | — | — | — |
| Age, Continuous(years) | ON101 Cream | Aquacel® Hydrofiber® Dressing | Total |
|---|---|---|---|
| Mean | 56.0 ± 10.7 | 55.9 ± 11.6 | 55.9 ± 11.13 |
| Sex: Female, Male(Participants) | ON101 Cream | Aquacel® Hydrofiber® Dressing | Total |
|---|---|---|---|
| Female | 21 | 23 | 44 |
| Male | 60 | 56 | 116 |
| Race and Ethnicity Not Collected(Participants) | ON101 Cream | Aquacel® Hydrofiber® Dressing | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Type of Diabetes Mellitus (DM)(Participants) | ON101 Cream | Aquacel® Hydrofiber® Dressing | Total |
|---|---|---|---|
| Type 1 Diabetes | 1 | 0 | 1 |
| Type 2 Diabetes | 80 | 79 | 159 |
| DM duration(Participants) | ON101 Cream | Aquacel® Hydrofiber® Dressing | Total |
|---|---|---|---|
| ≤2 years | 14 | 12 | 26 |
| >2 to ≤5 years | 8 | 8 | 16 |
| >5 to ≤10 years | 17 | 9 | 26 |
| >10 years | 42 | 50 | 92 |
| Smoking History(Participants) | ON101 Cream | Aquacel® Hydrofiber® Dressing | Total |
|---|---|---|---|
| Non-smoker | 47 | 56 | 103 |
| Former smoker | 12 | 10 | 22 |
| Current smoker | 22 | 13 | 35 |
| Alcohol history(Participants) | ON101 Cream | Aquacel® Hydrofiber® Dressing | Total |
|---|---|---|---|
| Non-drinker | 65 | 64 | 129 |
| Former drinker | 7 | 8 | 15 |
| Current drinker | 9 | 7 | 16 |
| Dialysis(Participants) | ON101 Cream | Aquacel® Hydrofiber® Dressing | Total |
|---|---|---|---|
| Hemodialysis | 4 | 3 | 7 |
| None | 77 | 75 | 152 |
| Missing data | 0 | 1 | 1 |
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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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