A Randomized,Double-blind,Placebo-controlled Clinical Study to Explore the Mechanism of Action of ON101 Cream in Patients With DFUs.

NCT04945161 | Completed

• 1 other identifier: ON101CLIIS01-DFU
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to explore the mechanistic role of ON101 cream in healing diabetic foot ulcers by determining the molecular targets of ON101 cream. Primary endpoint: Percentage change from baseline in the expression level of individual target gene(s) at protein and/or mRNA level. Secondary endpoints:

1. 1.Comparison of the gene and/or protein expression level of individual target between ON101 and Placebo groups
2. 2.Change from baseline in the wound microbiota composition in each group
3. 3.Comparison of the wound microbiota composition between ON101 and Placebo groups
4. 4.Comparison of the wound reduction rate in each group
5. 5.Correlation of wound reduction rate with the alternated level of each target gene in each group.

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• Primary endpoint:Q-RT-PCR, for the inflammation stage and the remodeling stage

  Percentage change from baseline in the expression level of individual target gene(s) at protein and/or mRNA level, usch as Q-RT-PCR, Cytokine, Chmokine, GFs.

  Through study completion, an average of 1 year

Secondary Outcomes (5)

• Secondary endpoint (1): IL-1b, IL-6, TNF, TGF, CXCL9, FGF2, and IL1RN!..ect.

  Based on each visit window for the first review, and through study completion, an average of 1 year for the final review

• Secondary endpoint (2): iNOS, CD86, CD80, CD163, CD206, KRT14, MMP12..ect.

  Based on each visit window for the first review, and through study completion, an average of 1 year for the final review

• Secondary endpoint (3): CO15A1, CD71, CD34..ect

  Based on each visit window for the first review, and through study completion, an average of 1 year for the final review

• Secondary endpoint (4):target ulcer size evaluation report (Area: perimeter, length, width )

  Based on each visit window for the first review, and through study completion, an average of 1 year for the final review

• Secondary endpoint (5): wound reduction rate of each target gene in each group

  Based on each visit window for the first review, and through study completion, an average of 1 year for the final review

Other Outcomes (3)

• Safety endpoint(1): Change from baseline in vital signs

  Based on each visit window for the first review, and through study completion, an average of 1 year for the final review

• Safety endpoint(2): Change from baseline in physical examination

  Based on each visit window for the first review, and through study completion, an average of 1 year for the final review

• Safety endpoint(3):Change from baseline in laboratory tests

  Based on each visit window for the first review, and through study completion, an average of 1 year for the final review

Study Arms (2)

Arm A: N = 6 ON101 plus SoC

EXPERIMENTAL

Twelve (12) eligible subjects with DFUs will be enrolled. These 12 subjects will be randomly assigned to receive either ON101 treatment plus SoC (Arm A) or Placebo plus SoC (Arm B) for six weeks. Treatment arm allocation will be done through randomization in a double-blind fashion. SoC will be provided from screening to the end of treatment. The SoC includes evaluation to ensure adequate arterial flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of moist wound environment via regular changing of dressings, and management of infection through oral antibiotics, if necessary.

Drug: ON101 Cream

Arm B: N = 6 Placebo plus SoC

PLACEBO COMPARATOR

Twelve (12) eligible subjects with DFUs will be enrolled. These 12 subjects will be randomly assigned to receive either ON101 treatment plus SoC (Arm A) or Placebo plus SoC (Arm B) for six weeks. Treatment arm allocation will be done through randomization in a double-blind fashion. SoC will be provided from screening to the end of treatment. The SoC includes evaluation to ensure adequate arterial flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of moist wound environment via regular changing of dressings, and management of infection through oral antibiotics, if necessary.

Other: Placebo

Interventions

ON101 Cream DRUG

Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica

Arm A: N = 6 ON101 plus SoC

Placebo OTHER

Placebo

Arm B: N = 6 Placebo plus SoC

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects, male or female, aged 20 to 80 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control.
• Subjects has a glycosylated hemoglobin, HbA1c \< 12%.
• Presence of at least one diabetic foot ulcer that meets all of the following criteria:
• At the time of Visit 0 (V0), the ulcer has existed for at least one month;
• At the time of Visit 1 (V1), the post-debridement ulcer presents Grade 2 or Grade 3 (without osteomyelitis or active infection) in Wagner Ulcer Classification System assessment; and
• Area should be ≥ 4 cm2 and ≤ 25 cm2;
• No higher than the ankle.
• Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.8 and ≤ 1.3.
• Clinically normal resting ECG at the first Screening Visit (V0) or, if abnormal, considered to be not clinically significant by the Investigator.
• Subject must use an off-loading method for the target ulcer on the plantar during the whole study period.
• Subject, if female of child-bearing potential, has a negative pregnancy test on urine at screening, must not be breastfeeding, and willing to use two medically accepted methods of contraception (e.g., barrier contraceptives \[female condom or diaphragm with a spermicidal gel\], hormonal contraceptives \[implants, injectables, combination oral contraceptives, transdermal patches, or contraceptives rings\], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and/or who have been sterilized).
• Subject is able and willing to comply with the study procedures.
• A signed and dated informed consent form has been obtained from the subject.

You may not qualify if:

• In response to standard of care (SoC), ulcer size reduction is ≥20% during the two-week run-in screening period (between the first Screening Visit/V0 and Baseline Visit/V1).
• Ulcers with exposed bone or associated with osteomyelitis. Note: The osteomyelitis should be ruled out by clinical examination (probing of the wound) or X-ray findings where find necessary by the Investigator.
• Presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement.
• Laboratory values at Screening of:
• Liver function test (total bilirubin, aspartate aminotransferase \[AST\], or alanine transaminase \[ALT\]) \> 3x the upper limit of normal, or
• Albumin \< 2.5 g/dL, or
• Renal function test (serum creatinine or urea) \> 2x 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, maybe 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 the following medication or therapies, could interfere with wound healing during the course of the study:
• Immunosuppressive or chemotherapeutic agents, radiotherapy, or systemic corticosteroids
• Autoimmune disease therapy

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead

Study Sites (1)

Kueiho Chen

Taipei, 106, Taiwan

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study design: 1. □Control: ■placebo * active (please specify name and dosage) * other * Uncontrolled 2. Blinding: □open-label □evaluator blind □single blind ■double blind □double dummy □other 3. Randomized: ■yes □no 4. ■Parallel □Cross-over □Other 5. Duration of treatment: Six (6) weeks 6. Titration: □forced □optional ■none 7. □Multi-national ■Multi-center(Taiwan): 2 sites □Single center
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, placebo-controlled clinical study to explore the mechanism of action (MOA) of ON101 cream in patients with diabetic foot ulcers (DFUs).The primary objective is to explore the mechanistic role of ON101 cream in healing diabetic foot ulcers by determining the molecular targets of ON101 cream.

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: June 30, 2021
• Study Start: February 23, 2021
• Primary Completion: November 9, 2021
• Study Completion: December 24, 2021
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)