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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04962139
Recruitment Status : Recruiting
First Posted : July 14, 2021
Last Update Posted : July 18, 2022
Sponsor:
Information provided by (Responsible Party):
Oneness Biotech Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Chronic Diabetic Foot Ulcers Drug: ON101 Cream Other: Vehicle Cream Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Phase-III Study to Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
Actual Study Start Date : August 10, 2021
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ON101 Cream plus Standard of Care
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
Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica

Placebo Comparator: Vehicle Cream plus Standard of Care

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
ON101 Cream Placebo




Primary Outcome Measures :
  1. The proportion of subjects with complete closure of Target Ulcer [ Time Frame: 20-week Treatment Phase ]
    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.


Secondary Outcome Measures :
  1. Time to complete closure of Target Ulcer [ Time Frame: 20-week Treatment Phase ]
    Time to complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by blinded independent evaluators.

  2. The proportion of patients with Target Ulcer recurrence [ Time Frame: 12-week Follow-Up Phase ]
    The proportion of patients with Target Ulcer recurrence, during the Follow-Up Phase.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subject has a glycosylated hemoglobin, HbA1c ≦ 12%.
  3. Presence of at least one diabetic foot ulcer that meets all of the following criteria:

    1. A full-thickness ulcer of UTWCS Grade I-A or II-A
    2. Ulcer size (area) is > 2 cm2 and ≤ 20 cm2 (post-debridement at time of randomization)
    3. Ulcer is located on or below the malleoli and present for > 4 weeks (at time of randomization)
    4. There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot (post-debridement)
    5. No active infection by clinical inspection 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.
  4. 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.
  5. 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).
  6. Subject should be able to walk and stand on the non-target ulcer limb.
  7. Subject is willing to use an off-loading device for the target ulcer on the plantar while ambulation for the duration of the study.
  8. Subject / identified caregiver trained on the study procedures is able and willing to comply with study procedures.
  9. A signed and dated informed consent form has been obtained from the subject prior to any study-related procedures being performed.

Exclusion Criteria:

  1. 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).
  2. 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.
  3. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
  4. Body mass index (BMI) > 42 kg/m2
  5. Laboratory values at Screening of:

    1. White Blood Cells (WBC) < 3.0 X 109 cells/L;> 12.0 X 109 cells/L
    2. Liver function studies [Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)] > 3x the upper limit of normal
    3. Albumin < 2.5 g/dL
    4. Renal function studies [Serum Creatinine and Urea] > 3x the upper limit of normal
  6. 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:

    1. Acute or unstable Charcot foot
    2. Current sepsis
    3. 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.
    4. Acquired immune deficiency syndrome (AIDS) or HIV positive.
  7. 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.

    1. immunosuppressants (including chronic systemic corticosteroids)
    2. cytotoxic chemotherapy
    3. cytostatic therapy
    4. autoimmune disease therapy
    5. dialysis
    6. lower limb revascularization surgery (e.g., angioplasty, artery bypass surgery)
    7. growth factors
    8. hyperbaric oxygen therapy
    9. bioengineered tissue or skin substitutes
    10. application of topical steroids to the ulcer surface
    11. use of any investigational drug(s)
  8. Subjects whose non-target ulcer limb is disabled or amputated above the ankle.
  9. Subject's target ulcer is located on the plantar foot with all toes amputated.
  10. Subjects who need to stand continuously for more than 4 hours / day and have difficulty complying with off-loading instruction.
  11. A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse, determined from the subject's medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance.
  12. Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04962139


Contacts
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Contact: Jessica Ho +886 2 2703 1098 ext 368 jessica.ho@onenessbio.com.tw
Contact: Lisa Liang +886 2 2703 1098 ext 366 Lisa.Liang@onenessbio.com.tw

Locations
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United States, Arizona
Oneness Investigational Site Recruiting
Mesa, Arizona, United States, 85206
United States, California
Oneness Investigational Site Recruiting
Carlsbad, California, United States, 92009
Oneness Investigational Site Recruiting
Castro Valley, California, United States, 94546
Oneness Investigational Site Recruiting
Fresno, California, United States, 93710
Oneness Investigational Site Withdrawn
Los Angeles, California, United States, 90026
Oneness Investigational Site Recruiting
San Francisco, California, United States, 94117
Oneness Investigational Site Not yet recruiting
Sylmar, California, United States, 91342
United States, Colorado
Oneness Investigational Site Withdrawn
Colorado Springs, Colorado, United States, 80903
United States, Florida
Oneness Investigational Site Recruiting
Miami Lakes, Florida, United States, 33016
Oneness Investigational Site Recruiting
Miami, Florida, United States, 33165
Oneness Investigational Site Recruiting
North Miami Beach, Florida, United States, 33321
United States, Illinois
Oneness Investigational Site Recruiting
Mount Prospect, Illinois, United States, 60056
Oneness Investigational Site Not yet recruiting
O'Fallon, Illinois, United States, 62269
Oneness Investigational Site Recruiting
Springfield, Illinois, United States, 62704
United States, Texas
Oneness Investigational Site Recruiting
Dallas, Texas, United States, 75251
Oneness Investigational Site Withdrawn
Houston, Texas, United States, 77024
Oneness Investigational Site Recruiting
McAllen, Texas, United States, 78501
Sponsors and Collaborators
Oneness Biotech Co., Ltd.
Investigators
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Study Director: Shyi-Gen Chen Oneness Biotech Co., Ltd.
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Responsible Party: Oneness Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT04962139    
Other Study ID Numbers: ON101CLCT04
First Posted: July 14, 2021    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases