Retrospective Record-review Study in Patients Who Had Diabetic Foot Ulcer
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Registration Number
- NCT05135130
- Lead Sponsor
- Oneness Biotech Co., Ltd.
- 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
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 176
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ON101 Cream ON101 Cream Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm
- Primary Outcome Measures
Name Time Method Wound characteristics of DFUs (classification and proportion) Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial Proportion of DFU recurrence after completing or withdrawing from the ON101CLCT02 trial Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial Medical costs due to DFUs Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial Demographic characteristics Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial Proportion of wound infection, gangrene, and amputation Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial Frequency of wound infection, gangrene, and amputation Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
China Medical University Hospital
🇨🇳Taichung City, Taiwan