Trial Outcomes & Findings for Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers (NCT NCT01898923)

Last Updated: 2021-04-14

Results Overview

The primary variable is the number of target ulcers healed in each group within 16 weeks. The primary efficacy outcome is the comparison of the incidence of complete healing of the target ulcer between the two treatment groups at the end of treatment. For the purpose of this study a complete healing will be defined as complete epithelialization which is maintained with no drainage for at least 2 weeks and is confirmed by a blinded assessor.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

236 participants

Primary outcome timeframe

16 weeks

Results posted on

2021-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	ON101 Cream ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. ON101 Cream	Aquacel® Hydrofiber® Dressing Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. Aquacel® Hydrofiber® dressing
Overall Study STARTED	122	114
Overall Study COMPLETED	106	93
Overall Study NOT COMPLETED	16	21

Reasons for withdrawal

Reasons for withdrawal
Measure	ON101 Cream ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. ON101 Cream	Aquacel® Hydrofiber® Dressing Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. Aquacel® Hydrofiber® dressing
Overall Study Lack of Efficacy	5	6
Overall Study Adverse Event	3	1
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	4	7
Overall Study Physician Decision	3	4
Overall Study One of the subjects IS NO LONGER USING AQUACEL STANDARD OF CARE AND WAS REMOVED FROM THE STUDY	1	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ON101 Cream n=122 Participants ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. ON101 Cream	Aquacel® Hydrofiber® Dressing n=114 Participants Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. Aquacel® Hydrofiber® dressing	Total n=236 Participants Total of all reporting groups
Age, Continuous	57.4 years STANDARD_DEVIATION 10.6 • n=122 Participants	56.6 years STANDARD_DEVIATION 11.3 • n=114 Participants	57.0 years STANDARD_DEVIATION 10.9 • n=236 Participants
Sex: Female, Male Female	29 Participants n=122 Participants	32 Participants n=114 Participants	61 Participants n=236 Participants
Sex: Female, Male Male	93 Participants n=122 Participants	82 Participants n=114 Participants	175 Participants n=236 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 participants n=122 Participants	4 participants n=114 Participants	8 participants n=236 Participants
Region of Enrollment China	20 participants n=122 Participants	20 participants n=114 Participants	40 participants n=236 Participants
Region of Enrollment Taiwan	98 participants n=122 Participants	90 participants n=114 Participants	188 participants n=236 Participants

PRIMARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	ON101 Cream n=122 Participants ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. ON101 Cream	Aquacel® Hydrofiber® Dressing n=114 Participants Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. Aquacel® Hydrofiber® dressing
Number of Participants With Complete Ulcer Closure	74 Participants	40 Participants

SECONDARY outcome

Timeframe: 16 weeks

Time to complete ulcer healing, The time of the original healing will be taken as the time to healing.

Outcome measures

Outcome measures
Measure	ON101 Cream n=122 Participants ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. ON101 Cream	Aquacel® Hydrofiber® Dressing n=114 Participants Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. Aquacel® Hydrofiber® dressing
The Time of Healing Rate	14 weeks Interval 14.0 to 14.3	NA weeks unable to be estimated by Kaplan-Meier method due to some subjects are not completely healed

SECONDARY outcome

Timeframe: 16 weeks

Percentage change in ulcer surface area from baseline

Outcome measures

Outcome measures
Measure	ON101 Cream n=122 Participants ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. ON101 Cream	Aquacel® Hydrofiber® Dressing n=114 Participants Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. Aquacel® Hydrofiber® dressing
Change in Ulcer Area week 16	-78 percentage change in ulcer surface area Standard Deviation 42.6	-78 percentage change in ulcer surface area Standard Deviation 34.9
Change in Ulcer Area week 2	-36 percentage change in ulcer surface area Standard Deviation 32.9	-38 percentage change in ulcer surface area Standard Deviation 29.3

SECONDARY outcome

Timeframe: 16 weeks

Percentage of subjects with a 50% reduction of ulcer surface area

Outcome measures

Outcome measures
Measure	ON101 Cream n=122 Participants ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. ON101 Cream	Aquacel® Hydrofiber® Dressing n=114 Participants Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. Aquacel® Hydrofiber® dressing
Percentage of Participants With a 50% Reduction of Ulcer Surface Area	101 Participants	98 Participants

SECONDARY outcome

Timeframe: 16 weeks

Incidence of infection of the target ulcer

Outcome measures

Outcome measures
Measure	ON101 Cream n=122 Participants ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. ON101 Cream	Aquacel® Hydrofiber® Dressing n=114 Participants Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. Aquacel® Hydrofiber® dressing
Incidence of Infection of the Target Ulcer	6 Participants	7 Participants

Adverse Events

ON101 Cream

Serious events: 14 serious events

Other events: 7 other events

Deaths: 1 deaths

Aquacel® Hydrofiber® Dressing

Serious events: 9 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	ON101 Cream n=122 participants at risk ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. ON101 Cream	Aquacel® Hydrofiber® Dressing n=114 participants at risk Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. Aquacel® Hydrofiber® dressing
General disorders Peripheral swelling	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
General disorders Pyrexia	0.00% 0/122 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.88% 1/114 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Infections and infestations Cellulitis	0.00% 0/122 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.88% 1/114 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Infections and infestations Osteomyelitis	0.00% 0/122 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.88% 1/114 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Infections and infestations Staphylococcal infection	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Injury, poisoning and procedural complications Wound complication	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Investigations Weight increased	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Metabolism and nutrition disorders Hyperuricaemia	1.6% 2/122 • Number of events 2 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/122 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.88% 1/114 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Skin and subcutaneous tissue disorders Dermatitis contact	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Skin and subcutaneous tissue disorders Diabetic foot infection	0.00% 0/122 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.88% 1/114 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Skin and subcutaneous tissue disorders Eczema	1.6% 2/122 • Number of events 2 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Skin and subcutaneous tissue disorders Erythema	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Skin and subcutaneous tissue disorders Rash	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)

Additional Information

Henry Chang, Associate Director of Clinical Research

Oneness Biotech Co., Ltd.

Phone: +886 2 2703 1098

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	ON101 Cream n=122 participants at risk ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. ON101 Cream	Aquacel® Hydrofiber® Dressing n=114 participants at risk Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. Aquacel® Hydrofiber® dressing
Cardiac disorders Cardiac failure	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.88% 1/114 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Cardiac disorders Acute myocardial infarction	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Infections and infestations Abscess limb	1.6% 2/122 • Number of events 2 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Infections and infestations Appendicitis	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Infections and infestations Cellulitis	2.5% 3/122 • Number of events 3 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.88% 1/114 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Infections and infestations Diabetic foot infection	0.00% 0/122 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.88% 1/114 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Infections and infestations Infected skin ulcer	0.00% 0/122 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	1.8% 2/114 • Number of events 2 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Infections and infestations Localised infection	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Infections and infestations Necrotising fasciitis	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Infections and infestations Osteomyelitis	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	1.8% 2/114 • Number of events 2 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Infections and infestations Pneumonia	0.00% 0/122 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.88% 1/114 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Infections and infestations staphylococcal sepsis	0.00% 0/122 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.88% 1/114 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Infections and infestations Urinary tract infection	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.88% 1/114 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/122 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.88% 1/114 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Metabolism and nutrition disorders Hypoglycaemia	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Metabolism and nutrition disorders Hypokalaemia	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Musculoskeletal and connective tissue disorders Soft tissue disorder	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Nervous system disorders Cerebral arteriosclerosis	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Nervous system disorders Cerebrovascular accident	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Nervous system disorders Ischaemic cerebral infarction	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Nervous system disorders Loss of consciousness	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Renal and urinary disorders Hydronephrosis	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	0.00% 0/114 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)
Skin and subcutaneous tissue disorders Diabetic foot	0.82% 1/122 • Number of events 1 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)	1.8% 2/114 • Number of events 2 • Adverse event collection began after study intervention was initiated and continued through the entire study visit. (Day 1 to Day 197)