Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers

Randomized Controlled Study to Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01898923

Enrollment

236

Registered

2013-07-15

Start date

2012-11-23

Completion date

2020-05-11

Last updated

2021-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot

Keywords

WH-1,Diabetic Foot,Ulcer

Brief summary

The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1 ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers for up to 16 weeks.An additional objective of this study is to collect safety information including adverse events and clinical laboratory abnormalities.

Detailed description

This trial is designed as a randomized, evaluator blinded, active-controlled, multi-center study comparing the efficacy and safety of WH-1 ointment and Aquacel® Hydrofiber® dressing in the treatment of diabetic foot ulcers. Independent evaluators who blinded to subjects' treatment will evaluate whether the wound has healed. Eligible subjects will be randomized to receive either WH-1 ointment or Aquacel® Hydrofiber® dressing in a 1:1 allocation. The study treatment will be applied to the selected ulcer for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of comparison period will be followed for 12 weeks to investigate durability. During the follow-up period, Aquacel® Hydrofiber® dressing will be applied for subjects who have unhealed or with recurrent wound. Each target ulcer with wound photographs for blind assessment will be monitored at each scheduled visit. One interim analysis is planned at around 50% of study information; the final analysis will be conducted at the end of the study.

Interventions

DRUGON101 Cream

OTHERAquacel® Hydrofiber® dressing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Has signed a written informed consent prior to the first study evaluation; 2. Male or female is at least 20 and \< 80 years of age; 3. Diabetes mellitus (type 1 or 2) with an HbA1c \< 12.0% measured during screening or within three months prior to randomization; 4. An ankle brachial index on the target limb at least 0.8 measured during screening or within three months prior to randomization; 5. The target ulcer must have the following characteristics: * Grade 1 or 2 per Wagner Ulcer Classification System; * No higher than the ankle; * No active infected; * A cross-sectional area of between 1 and 25 cm2 post-debridement; * Present for at least 4 weeks before randomization; 6. If female and of childbearing potential has a negative pregnancy test and is not breastfeeding at screening visit; 7. Able and willing to attend the scheduled visits and comply with study procedures.

Exclusion criteria

1. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement; 2. Acute Charcot's neuroarthropathy as determined by clinical and/or radiographic examination; 3. Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb \< 4 weeks prior to randomization; 4. Poor nutritional status defined as an albumin \< 2.5 g/dL; 5. Aspartate Aminotransferase(AST, GOT) and/or Alanine Aminotransferase(ALT, GPT) \>3 x the normal upper limit; 6. Serum Creatinine \>2 x the normal upper limit; 7. Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 4 weeks before randomization; 8. Use of any investigational drug or therapy within the 4 weeks prior to randomization; 9. A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject's medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance; 10. Judged by the investigator not to be suitable for the study for any other reason.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Complete Ulcer Closure	16 weeks	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.

Secondary

Measure	Time frame	Description
The Time of Healing Rate	16 weeks	Time to complete ulcer healing, The time of the original healing will be taken as the time to healing.
Change in Ulcer Area	16 weeks	Percentage change in ulcer surface area from baseline
Percentage of Participants With a 50% Reduction of Ulcer Surface Area	16 weeks	Percentage of subjects with a 50% reduction of ulcer surface area
Incidence of Infection of the Target Ulcer	16 weeks	Incidence of infection of the target ulcer

Countries

China, Taiwan, United States

Participant flow

Participants by arm

Arm	Count
ON101 Cream ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. ON101 Cream	122
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	114
Total	236

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	3	1
Overall Study	Lack of Efficacy	5	6
Overall Study	Lost to Follow-up	0	1
Overall Study	One of the subjects IS NO LONGER USING AQUACEL STANDARD OF CARE AND WAS REMOVED FROM THE STUDY	1	2
Overall Study	Physician Decision	3	4
Overall Study	Withdrawal by Subject	4	7

Baseline characteristics

Characteristic	ON101 Cream	Aquacel® Hydrofiber® Dressing	Total
Age, Continuous	57.4 years STANDARD_DEVIATION 10.6	56.6 years STANDARD_DEVIATION 11.3	57.0 years STANDARD_DEVIATION 10.9
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment China	20 participants	20 participants	40 participants
Region of Enrollment Taiwan	98 participants	90 participants	188 participants
Region of Enrollment United States	4 participants	4 participants	8 participants
Sex: Female, Male Female	29 Participants	32 Participants	61 Participants
Sex: Female, Male Male	93 Participants	82 Participants	175 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 122	0 / 114
other Total, other adverse events	7 / 122	5 / 114
serious Total, serious adverse events	14 / 122	9 / 114

Arm	Measure	Value (MEDIAN)
ON101 Cream	The Time of Healing Rate	14 weeks
Aquacel® Hydrofiber® Dressing	The Time of Healing Rate	NA weeks

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026