Trial Outcomes & Findings for Retrospective Record-review Study in Patients Who Had Diabetic Foot Ulcer (NCT NCT05135130)
NCT ID: NCT05135130
Last Updated: 2026-03-06
Results Overview
COMPLETED
160 participants
Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
2026-03-06
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
79
|
|
Overall Study
COMPLETED
|
81
|
79
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ON101 Cream
n=81 Participants
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm
|
Aquacel® Hydrofiber® Dressing
n=79 Participants
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 10.7 • n=81 Participants
|
55.9 years
STANDARD_DEVIATION 11.6 • n=79 Participants
|
55.9 years
STANDARD_DEVIATION 11.13 • n=160 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=81 Participants
|
23 Participants
n=79 Participants
|
44 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=81 Participants
|
56 Participants
n=79 Participants
|
116 Participants
n=160 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Type of Diabetes Mellitus (DM)
Type 1 Diabetes
|
1 Participants
n=81 Participants
|
0 Participants
n=79 Participants
|
1 Participants
n=160 Participants
|
|
Type of Diabetes Mellitus (DM)
Type 2 Diabetes
|
80 Participants
n=81 Participants
|
79 Participants
n=79 Participants
|
159 Participants
n=160 Participants
|
|
DM duration
≤2 years
|
14 Participants
n=81 Participants
|
12 Participants
n=79 Participants
|
26 Participants
n=160 Participants
|
|
DM duration
>2 to ≤5 years
|
8 Participants
n=81 Participants
|
8 Participants
n=79 Participants
|
16 Participants
n=160 Participants
|
|
DM duration
>5 to ≤10 years
|
17 Participants
n=81 Participants
|
9 Participants
n=79 Participants
|
26 Participants
n=160 Participants
|
|
DM duration
>10 years
|
42 Participants
n=81 Participants
|
50 Participants
n=79 Participants
|
92 Participants
n=160 Participants
|
|
Smoking History
Non-smoker
|
47 Participants
n=81 Participants
|
56 Participants
n=79 Participants
|
103 Participants
n=160 Participants
|
|
Smoking History
Former smoker
|
12 Participants
n=81 Participants
|
10 Participants
n=79 Participants
|
22 Participants
n=160 Participants
|
|
Smoking History
Current smoker
|
22 Participants
n=81 Participants
|
13 Participants
n=79 Participants
|
35 Participants
n=160 Participants
|
|
Alcohol history
Non-drinker
|
65 Participants
n=81 Participants
|
64 Participants
n=79 Participants
|
129 Participants
n=160 Participants
|
|
Alcohol history
Former drinker
|
7 Participants
n=81 Participants
|
8 Participants
n=79 Participants
|
15 Participants
n=160 Participants
|
|
Alcohol history
Current drinker
|
9 Participants
n=81 Participants
|
7 Participants
n=79 Participants
|
16 Participants
n=160 Participants
|
|
Dialysis
Hemodialysis
|
4 Participants
n=81 Participants
|
3 Participants
n=79 Participants
|
7 Participants
n=160 Participants
|
|
Dialysis
None
|
77 Participants
n=81 Participants
|
75 Participants
n=79 Participants
|
152 Participants
n=160 Participants
|
|
Dialysis
Missing data
|
0 Participants
n=81 Participants
|
1 Participants
n=79 Participants
|
1 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.Outcome measures
| Measure |
ON101 Cream
n=81 Participants
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm
|
Aquacel® Hydrofiber® Dressing
n=79 Participants
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm
|
|---|---|---|
|
Demographic Characteristics: Weight (Mean)
|
73.7 kg
Standard Deviation 15.0
|
78.3 kg
Standard Deviation 17.3
|
PRIMARY outcome
Timeframe: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.Outcome measures
| Measure |
ON101 Cream
n=81 Participants
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm
|
Aquacel® Hydrofiber® Dressing
n=79 Participants
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm
|
|---|---|---|
|
Demographic Characteristics: BP (Mean)
SBP
|
132 mmHg
Standard Deviation 25.2
|
144 mmHg
Standard Deviation 27.6
|
|
Demographic Characteristics: BP (Mean)
DBP
|
74.8 mmHg
Standard Deviation 14.3
|
77.4 mmHg
Standard Deviation 14.2
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
ON101 Cream
n=81 Participants
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm
|
Aquacel® Hydrofiber® Dressing
n=79 Participants
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm
|
|---|---|---|
|
Demographic Characteristics: ABI (Mean)
Left ABI
|
1.1 ABI
Standard Deviation 0.1
|
1.0 ABI
Standard Deviation 0.2
|
|
Demographic Characteristics: ABI (Mean)
Right ABI
|
0.9 ABI
Standard Deviation 0.2
|
1.1 ABI
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.Population: 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.
The total medical cost due to diabetic foot ulcers across 140 participants is reported.
Outcome measures
| Measure |
ON101 Cream
n=71 Participants
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm
|
Aquacel® Hydrofiber® Dressing
n=69 Participants
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm
|
|---|---|---|
|
Medical Costs Due to DFUs
|
19852.0 NTD
Standard Deviation 25840.2
|
25671.9 NTD
Standard Deviation 31365.4
|
PRIMARY outcome
Timeframe: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.Population: 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).
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 measures
| Measure |
ON101 Cream
n=51 Participants
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm
|
Aquacel® Hydrofiber® Dressing
n=30 Participants
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm
|
|---|---|---|
|
Percentage of Amputation
Major amputation
|
0.00 Participants
|
1 Participants
|
|
Percentage of Amputation
Minor amputation
|
1 Participants
|
2 Participants
|
|
Percentage of Amputation
Total amputation
|
1 Participants
|
3 Participants
|
Adverse Events
ON101 Cream
Aquacel® Hydrofiber® Dressing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place