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

Diabetic Foot Clinical Trial

Official title:

Randomized Controlled Study to Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898923
• Other study ID #: ON101CLCT02
• Status: Completed
• Phase: Phase 3
• Start date: November 23, 2012
• Est. completion date: May 11, 2020

Study information

• Verified date: March 2021
• Source: Oneness Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: May 11, 2020
• Est. primary completion date: May 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer

Intervention

Drug:
• ON101 Cream

Other:
• Aquacel® Hydrofiber® dressing

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Oneness Biotech Co., Ltd.

Countries where clinical trial is conducted

United States,  China,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in Ulcer Area	Percentage change in ulcer surface area from baseline	16 weeks
Secondary	Percentage of Participants With a 50% Reduction of Ulcer Surface Area	Percentage of subjects with a 50% reduction of ulcer surface area	16 weeks
Secondary	Incidence of Infection of the Target Ulcer	Incidence of infection of the target ulcer	16 weeks