Diabetic Foot Ulcer
Conditions
Brief 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.
Detailed description
This ClinicalTrials.gov record exists that reports results for the ON101CLCT02 trial.(identifier: NCT01898923)
Interventions
DRUGON101 Cream
Not applicable in this retrospective study
Sponsors
Oneness Biotech Co., Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
No additional inclusion or
Exclusion criteria
will be applied.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demographic Characteristics: Weight (Mean) | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.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| Demographic Characteristics: BP (Mean) | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.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| Demographic Characteristics: ABI (Mean) | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.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| Medical Costs Due to DFUs | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.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| Percentage of Amputation | Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.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. |
Countries
Taiwan
Contacts
STUDY_DIRECTORShyi-Gen Chen, MD
Oneness Biotech Co., Ltd.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55.9 years STANDARD_DEVIATION 11.6 |
| Alcohol history Current drinker | 9 Participants |
| Alcohol history Former drinker | 15 Participants |
| Alcohol history Non-drinker | 65 Participants |
| Dialysis Hemodialysis | 3 Participants |
| Dialysis Missing data | 1 Participants |
| Dialysis None | 77 Participants |
| DM duration >10 years | 42 Participants |
| DM duration >2 to ≤5 years | 8 Participants |
| DM duration ≤2 years | 26 Participants |
| DM duration >5 to ≤10 years | 26 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 116 Participants |
| Smoking History Current smoker | 13 Participants |
| Smoking History Former smoker | 12 Participants |
| Smoking History Non-smoker | 103 Participants |
| Type of Diabetes Mellitus (DM) Type 1 Diabetes | 1 Participants |
| Type of Diabetes Mellitus (DM) Type 2 Diabetes | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed