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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot
• Intervention / Treatment: Drug: ON101 Cream; Other: Aquacel® Hydrofiber® dressing

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.

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    • Guanzhou, Guangdong, China
      • Nanfang Hospital of Southern Medical University
    • Guanzhou, Guangdong, China
      • The First Affiliated Hospital, Sun Yat-sen University
  • Henan
    • Luoyang, Henan, China
      • The First Affiliated Hospital of Henan Science & Technology University
  • Jiangsu
    • Suzhou, Jiangsu, China
      • The First Affiliated Hospital of Soochow University
    • Zhenjiang, Jiangsu, China
      • Affiliated Hospital of Jiangsu University
  • Shandong
    • Jinan, Shandong, China
      • Shandong Provincial Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai, China
      • Shanghai TCM-Interated Hospital
• Taiwan
  • Kaohsiung, Taiwan
    • Chang Gung Medical Hospital_Kaohsiung
  • New Taipei City, Taiwan
    • Buddhist Tzu Chi Medical Hospital
  • New Taipei City, Taiwan
    • MacKay Memorial Hospital-Tamsui Branch
  • Taichung City, Taiwan
    • China Medical University Hospital
  • Tainan City, Taiwan
    • Chi Mei Medical Center-Yongkang
  • Taipei City, Taiwan
    • Taipei Veterans General Hospital
  • Taipei City, Taiwan
    • National Taiwan University Hospital
  • Taipei City, Taiwan
    • Mackay Memorial Hospital-Taipei Branch
  • Taipei City, Taiwan
    • Tri-Service General Hospital
  • Taoyuan City, Taiwan
    • Chang Gung Medical Hospital_Linkou
  • Yunlin, Taiwan, 651
    • China Medical University Hospital-Beigang Branch
• United States
  • California
    • Fresno, California, United States
      • Limb Preservation Platform, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ON101 Cream; ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks.	Drug: ON101 Cream; Other Names: WH-1
Other: 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.	Other: Aquacel® Hydrofiber® dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oneness Biotech Co., Ltd.
• Investigators: Study Director: Henry Chang, Oneness Biotech

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2012
• Primary Completion (Actual): May 11, 2020
• Study Completion (Actual): May 11, 2020

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 10, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: WH-1,Diabetic Foot,Ulcer
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: ON101CLCT02