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

Primary Purpose

Diabetic Foot

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ON101 Cream
Aquacel® Hydrofiber® dressing
Sponsored by
Oneness Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring WH-1,Diabetic Foot,Ulcer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Limb Preservation Platform, Inc.
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Nanfang Hospital of Southern Medical University
  • The First Affiliated Hospital, Sun Yat-sen University
  • The First Affiliated Hospital of Henan Science & Technology University
  • The First Affiliated Hospital of Soochow University
  • Affiliated Hospital of Jiangsu University
  • Shandong Provincial Hospital
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai TCM-Interated Hospital
  • Chang Gung Medical Hospital_Kaohsiung
  • Buddhist Tzu Chi Medical Hospital
  • MacKay Memorial Hospital-Tamsui Branch
  • China Medical University Hospital
  • Chi Mei Medical Center-Yongkang
  • MacKay Memorial Hospital-Taipei Branch
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Tri-Service General Hospital
  • Chang Gung Medical Hospital_Linkou
  • China Medical University Hospital-Beigang Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ON101 Cream

Aquacel® Hydrofiber® dressing

Arm Description

ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks.

Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 8, 2013
Last Updated
March 19, 2021
Sponsor
Oneness Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01898923
Brief Title
Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
Official Title
Randomized Controlled Study to Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 23, 2012 (Actual)
Primary Completion Date
May 11, 2020 (Actual)
Study Completion Date
May 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oneness Biotech Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
Keywords
WH-1,Diabetic Foot,Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ON101 Cream
Arm Type
Experimental
Arm Description
ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks.
Arm Title
Aquacel® Hydrofiber® dressing
Arm Type
Other
Arm Description
Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days.
Intervention Type
Drug
Intervention Name(s)
ON101 Cream
Other Intervention Name(s)
WH-1
Intervention Type
Other
Intervention Name(s)
Aquacel® Hydrofiber® dressing
Primary Outcome Measure Information:
Title
Number of Participants With Complete Ulcer Closure
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
The Time of Healing Rate
Description
Time to complete ulcer healing, The time of the original healing will be taken as the time to healing.
Time Frame
16 weeks
Title
Change in Ulcer Area
Description
Percentage change in ulcer surface area from baseline
Time Frame
16 weeks
Title
Percentage of Participants With a 50% Reduction of Ulcer Surface Area
Description
Percentage of subjects with a 50% reduction of ulcer surface area
Time Frame
16 weeks
Title
Incidence of Infection of the Target Ulcer
Description
Incidence of infection of the target ulcer
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Chang
Organizational Affiliation
Oneness Biotech
Official's Role
Study Director
Facility Information:
Facility Name
Limb Preservation Platform, Inc.
City
Fresno
State/Province
California
Country
United States
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Nanfang Hospital of Southern Medical University
City
Guanzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guanzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Henan Science & Technology University
City
Luoyang
State/Province
Henan
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
Country
China
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai TCM-Interated Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Chang Gung Medical Hospital_Kaohsiung
City
Kaohsiung
Country
Taiwan
Facility Name
Buddhist Tzu Chi Medical Hospital
City
New Taipei City
Country
Taiwan
Facility Name
MacKay Memorial Hospital-Tamsui Branch
City
New Taipei City
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung City
Country
Taiwan
Facility Name
Chi Mei Medical Center-Yongkang
City
Tainan City
Country
Taiwan
Facility Name
MacKay Memorial Hospital-Taipei Branch
City
Taipei City
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei City
Country
Taiwan
Facility Name
Chang Gung Medical Hospital_Linkou
City
Taoyuan City
Country
Taiwan
Facility Name
China Medical University Hospital-Beigang Branch
City
Yunlin
ZIP/Postal Code
651
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
34477854
Citation
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.
Results Reference
derived

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

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