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

NCT04962139 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: ON101CLCT04
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 14

Brief Summary

The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by the blinded independent evaluator.

Conditions

Chronic Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with complete closure of Target Ulcer

  The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by blinded independent evaluators.

  20-week Treatment Phase

Secondary Outcomes (3)

• Time to complete closure of Target Ulcer

  20-week Treatment Phase

• The proportion of patients with Target Ulcer recurrence

  12-week Follow-Up Phase

• Mean change in EQ-5D-5L utility score

  Day 141

Study Arms (2)

ON101 Cream plus Standard of Care

EXPERIMENTAL

ON101 cream will be applied twice daily for up to 20 weeks to the Target Ulcer. The SOC will include evaluation to ensure adequate blood flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment via regular dressing changes, and management of infection through oral antibiotics, if necessary.

Drug: ON101 Cream

Vehicle Cream plus Standard of Care

PLACEBO COMPARATOR

Vehicle cream will be applied twice daily for up to 20 weeks to the Target Ulcer. The SOC will include evaluation to ensure adequate blood flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment via regular dressing changes, and management of infection through oral antibiotics, if necessary.

Other: Vehicle Cream

Interventions

ON101 Cream DRUG

Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica

ON101 Cream plus Standard of Care

Vehicle Cream OTHER

ON101 Cream Placebo

Vehicle Cream plus Standard of Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects, male or female, aged 18 to 80 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control using available diabetes drugs including insulin.
• Subject has a glycosylated hemoglobin, HbA1c ≦ 12%.
• Presence of at least one diabetic foot ulcer that meets all of the following criteria:
• A full-thickness ulcer of UTWCS Grade I-A or II-A
• Ulcer size (area) is \> 1 cm2 and ≤ 20 cm2 (post-debridement at time of screening and randomization)
• Ulcer is located on or below the malleoli and presents duration of between 6 weeks and 12 months (at time of screening).
• There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot (post-debridement)
• No active infection by clinical inspection as defined by IDSA/IWGDF criteria Note: If the subject has more than one qualifying diabetic foot ulcer, the most severe ulcer will be designated as the target ulcer.
• Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) \> 0.8 and \< 1.3, and transcutaneous pressure of oxygen (TcPO2) \> 30 mmHg on at least one lead.
• Subject, if female of child-bearing potential, has a negative serum pregnancy test at screening, must not be breastfeeding, and willing to use 2 medically accepted methods of contraception (e.g., barrier contraceptives \[female condom, or diaphragm with a spermicidal gel\], hormonal contraceptives \[implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings\], and intrauterine devices) during the study (excluding women who are not of childbearing potential and/or who have been sterilized).
• Subject should be able to walk and stand on the non-target ulcer limb.
• Subject is willing to use an off-loading device for the target ulcer on the plantar while ambulation for the duration of the study.
• Subject / identified caregiver trained on the study procedures is able and willing to comply with study procedures.
• A signed and dated informed consent form has been obtained from the subject prior to any study-related procedures being performed.

You may not qualify if:

• In response to standard of care, ulcer size reduction is \> 30% during the two-week run-in Screening Period (between the first Screening Visit/V0 and Baseline/V2).
• Ulcers with exposed bone or associated with osteomyelitis. Note: The osteomyelitis should be ruled out by clinical examination (probing of the wound) and X-ray findings.
• Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
• Body mass index (BMI) \> 42 kg/m2
• Laboratory values at Screening of:
• White Blood Cells (WBC) \< 3.0 X 109 cells/L；\> 12.0 X 109 cells/L
• Liver function studies \[Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)\] \> 3x the upper limit of normal
• Albumin \< 2.5 g/dL
• Renal function studies \[Serum Creatinine and Urea\] \> 3x the upper limit of normal
• Presence of any clinically significant medical condition(s) in medical history during screening period that, in the opinion of the investigator, could interfere with wound healing, including but not limited to the following:
• Acute or unstable Charcot foot
• Current sepsis
• Active malignant disease. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
• Acquired immune deficiency syndrome (AIDS) or HIV positive.
• Subject is currently receiving (i.e., within 30 days of randomization visit) or scheduled to receive any of following medication or therapies, could interfere with wound healing during the study.

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead

Study Sites (14)

Oneness Investigational Site

Mesa, Arizona, 85206, United States

Location

Oneness Investigational Site

Carlsbad, California, 92009, United States

Location

Oneness Investigational Site

Castro Valley, California, 94546, United States

Location

Oneness Investigational Site

Fresno, California, 93710, United States

Location

Oneness Investigational Site

San Francisco, California, 94117, United States

Location

Oneness Investigational Site

Sylmar, California, 91342, United States

Location

Oneness Investigational Site

Miami, Florida, 33165, United States

Location

Oneness Investigational Site

Miami Lakes, Florida, 33016, United States

Location

Oneness Investigational Site

North Miami Beach, Florida, 33321, United States

Location

Oneness Investigational Site

Mount Prospect, Illinois, 60056, United States

Location

Oneness Investigational Site

O'Fallon, Illinois, 62269, United States

Location

Oneness Investigational Site

Springfield, Illinois, 62704, United States

Location

Oneness Investigational Site

Dallas, Texas, 75251, United States

Location

Oneness Investigational Site

McAllen, Texas, 78501, United States

Location

Study Officials

• Shyi-Gen Chen

  Oneness Biotech Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 14, 2021
• Study Start: July 27, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 29, 2022
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

US (14)