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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ON101 Cream | Patients 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ON101 Cream | Drug | Not applicable in this retrospective study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demographic Characteristics: Weight (Mean) | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial. | |
| Demographic Characteristics: BP (Mean) | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.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. | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.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. | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.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. | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial. |
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No additional inclusion or exclusion criteria will be applied.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Shyi-Gen Chen, MD | Oneness Biotech Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | 404 | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | ON101 Cream | Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm |
| FG001 | Aquacel® Hydrofiber® Dressing | Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ON101 Cream | Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm |
| BG001 | Aquacel® Hydrofiber® Dressing | Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Demographic Characteristics: Weight (Mean) | Posted | Mean | Standard Deviation | kg | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial. |
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N/A. Adverse Events were not monitored/assessed in this retrospective study.
Adverse Events were not monitored/assessed in this retrospective study. This is a retrospective study; therefore, systematic monitoring for Adverse Events (AEs) was not performed according to a prospective protocol. As a result, no specific data for Serious or Other Adverse Events are available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ON101 Cream | Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Ho | Oneness Biotech Co., Ltd. | +886 2703 1098 | jesssica.ho@onenessbio.com.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 3, 2021 | Feb 12, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type of Diabetes Mellitus (DM) | Count of Participants | Participants |
|
| DM duration | Count of Participants | Participants |
|
| Smoking History | Count of Participants | Participants |
|
| Alcohol history | Count of Participants | Participants |
|
| Dialysis | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
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| Primary | Demographic Characteristics: BP (Mean) | Posted | Mean | Standard Deviation | mmHg | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ABI | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial. |
|
|
|
| Primary | Medical Costs Due to DFUs | The total medical cost due to diabetic foot ulcers across 140 participants is reported. | 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. | Posted | Mean | Standard Deviation | NTD | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial. |
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| Primary | 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. | Outcome 5 shows an analysis of amputation in patients whose target ulcers were completely healed in the trial (51 patients in the ON101 group and 30 patients in the Aquacel group). | Posted | Count of Participants | Participants | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial. |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Aquacel® Hydrofiber® Dressing | Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm | 0 | 0 | 0 | 0 | 0 | 0 |
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| >5 to ≤10 years |
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| >10 years |
|
| Current smoker |
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| Current drinker |
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| Missing data |
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| Total amputation |
|