Status:
COMPLETED
Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
Lead Sponsor:
Oneness Biotech Co., Ltd.
Conditions:
Diabetic Foot
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
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 we...
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 o...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
November 23 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2020
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT01898923
Start Date
November 23 2012
End Date
May 11 2020
Last Update
April 14 2021
Active Locations (21)
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1
Limb Preservation Platform, Inc.
Fresno, California, United States
2
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
3
Nanfang Hospital of Southern Medical University
Guanzhou, Guangdong, China
4
The First Affiliated Hospital, Sun Yat-sen University
Guanzhou, Guangdong, China