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

Phase 3

Terminated

• Conditions: Chronic Diabetic Foot Ulcers
• Interventions: Other: Vehicle Cream; Drug: ON101 Cream

• Registration Number: NCT04962139
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-14
• Study Start: 2021-07-27
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 > 1 cm2 and ≤ 20 cm2 (post-debridement at time of screening and randomization)
   3. Ulcer is located on or below the malleoli and presents duration of between 6 weeks and 12 months (at time of screening).
   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 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.

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
   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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle Cream plus Standard of Care	Vehicle Cream	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.
ON101 Cream plus Standard of Care	ON101 Cream	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.

Primary Outcome Measures

Name	Time	Method
The proportion of subjects with complete closure of Target Ulcer	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

Name	Time	Method
Time to complete closure of Target Ulcer	20-week Treatment Phase	Time to complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by blinded independent evaluators.
The proportion of patients with Target Ulcer recurrence	12-week Follow-Up Phase	The proportion of patients with Target Ulcer recurrence during the Follow-Up Phase.
Mean change in EQ-5D-5L utility score	Day 141	Mean change from baseline in EQ-5D-5L utility score at V12/EOT.

Trial Locations

Locations (1)

Oneness Investigational Site; 🇺🇸 McAllen, Texas, United States