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
1 other identifier
interventional
236
3 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2012
Longer than P75 for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 23, 2012
CompletedFirst Submitted
Initial submission to the registry
July 8, 2013
CompletedFirst Posted
Study publicly available on registry
July 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2020
CompletedResults Posted
Study results publicly available
April 14, 2021
CompletedApril 14, 2021
March 1, 2021
7.5 years
July 8, 2013
February 18, 2021
March 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Complete Ulcer Closure
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.
16 weeks
Secondary Outcomes (4)
The Time of Healing Rate
16 weeks
Change in Ulcer Area
16 weeks
Percentage of Participants With a 50% Reduction of Ulcer Surface Area
16 weeks
Incidence of Infection of the Target Ulcer
16 weeks
Study Arms (2)
ON101 Cream
EXPERIMENTALON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks.
Aquacel® Hydrofiber® dressing
OTHERAquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days.
Interventions
Eligibility Criteria
You may qualify if:
- Has signed a written informed consent prior to the first study evaluation;
- Male or female is at least 20 and \< 80 years of age;
- Diabetes mellitus (type 1 or 2) with an HbA1c \< 12.0% measured during screening or within three months prior to randomization;
- An ankle brachial index on the target limb at least 0.8 measured during screening or within three months prior to randomization;
- 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;
- If female and of childbearing potential has a negative pregnancy test and is not breastfeeding at screening visit;
- Able and willing to attend the scheduled visits and comply with study procedures.
You may not qualify if:
- Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;
- Acute Charcot's neuroarthropathy as determined by clinical and/or radiographic examination;
- Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb \< 4 weeks prior to randomization;
- Poor nutritional status defined as an albumin \< 2.5 g/dL;
- Aspartate Aminotransferase(AST, GOT) and/or Alanine Aminotransferase(ALT, GPT) \>3 x the normal upper limit;
- Serum Creatinine \>2 x the normal upper limit;
- Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 4 weeks before randomization;
- Use of any investigational drug or therapy within the 4 weeks prior to randomization;
- 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;
- Judged by the investigator not to be suitable for the study for any other reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Limb Preservation Platform, Inc.
Fresno, California, United States
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guanzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guanzhou, Guangdong, China
The First Affiliated Hospital of Henan Science & Technology University
Luoyang, Henan, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Shandong Provincial Hospital
Jinan, Shandong, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai TCM-Interated Hospital
Shanghai, Shanghai Municipality, China
Chang Gung Medical Hospital_Kaohsiung
Kaohsiung City, Taiwan
Buddhist Tzu Chi Medical Hospital
New Taipei City, Taiwan
MacKay Memorial Hospital-Tamsui Branch
New Taipei City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Chi Mei Medical Center-Yongkang
Tainan, Taiwan
MacKay Memorial Hospital-Taipei Branch
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Medical Hospital_Linkou
Taoyuan, Taiwan
China Medical University Hospital-Beigang Branch
Yunlin, 651, Taiwan
Related Publications (1)
Huang YY, Lin CW, Cheng NC, Cazzell SM, Chen HH, Huang KF, Tung KY, Huang HL, Lin PY, Perng CK, Shi B, Liu C, Ma Y, Cao Y, Li Y, Xue Y, Yan L, Li Q, Ning G, Chang SC. Effect of a Novel Macrophage-Regulating Drug on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2122607. doi: 10.1001/jamanetworkopen.2021.22607.
PMID: 34477854DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Henry Chang, Associate Director of Clinical Research
- Organization
- Oneness Biotech Co., Ltd.
Study Officials
- STUDY DIRECTOR
Henry Chang
Oneness Biotech
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2013
First Posted
July 15, 2013
Study Start
November 23, 2012
Primary Completion
May 11, 2020
Study Completion
May 11, 2020
Last Updated
April 14, 2021
Results First Posted
April 14, 2021
Record last verified: 2021-03