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

Completed · Phase 3

Conditions studied: Diabetic Foot

In brief

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.

Key facts

Study ID

NCT01898923

Run by

Oneness Biotech Co., Ltd.

People needed

236

Starts

2012-11-23

Expected to finish

2020-05-11

Last updated by the study team

2021-04-14

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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 City, Taiwan
• China Medical University Hospital-Beigang Branch — Yunlin, Taiwan

Full record on ClinicalTrials.gov

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