Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-29 @ 2:06 PM
Study NCT ID:
NCT04945161
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2021-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized,Double-blind,Placebo-controlled Clinical Study to Explore the Mechanism of Action of ON101 Cream in Patients With DFUs.
Sponsor:
Oneness Biotech Co., Ltd.
Organization:
Study Overview
Official Title:
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).
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. Comparison of the gene and/or protein expression level of individual target between ON101 and Placebo groups
2. Change from baseline in the wound microbiota composition in each group
3. Comparison of the wound microbiota composition between ON101 and Placebo groups
4. Comparison of the wound reduction rate in each group
5. Correlation of wound reduction rate with the alternated level of each target gene in each group.
Safety endpoints:
Incidence of treatment-emergent adverse event (AE) Change from baseline in vital signs, physical examination, and laboratory tests
Primary endpoint:
Percentage change from baseline in the expression level of individual target gene(s) at protein and/or mRNA level.
Secondary endpoints:
1. Comparison of the gene and/or protein expression level of individual target between ON101 and Placebo groups
2. Change from baseline in the wound microbiota composition in each group
3. Comparison of the wound microbiota composition between ON101 and Placebo groups
4. Comparison of the wound reduction rate in each group
5. Correlation of wound reduction rate with the alternated level of each target gene in each group.
Safety endpoints:
Incidence of treatment-emergent adverse event (AE) Change from baseline in vital signs, physical examination, and laboratory tests
Detailed Description:
This is a multicenter, randomized, double-blind, placebo-controlled study to explore the mechanism of action (MOA) of ON101 in treating chronic diabetic foot ulcers (DFUs). There will be 6 subjects ON101 treatment (Arm A) and 6 subjects in Placebo (Arm B) .
Twelve(12) eligible subjects with DFUs and are not undergoing dialysis will be enrolled and randomly assigned to receive either ON101 treatment (Arm A) or Placebo (Arm B) for six weeks. Treatment arm allocation will be done through randomization in a double-blind fashion. SoC will be provided throughout the study period.Subjects with DFUs not undergoing dialysis, N = 12 Arm A: ON101 plus SoC, N = 6 Arm B: Placebo plus SoC, N =6 SoC will be provided throughout the study period (from screening to end of treatment). 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.
The study will have three periods, a Screening/Run-in Period, a Treatment Period, and a Safety Follow-up Period.
Screening/Run-in Period (14 days):
Treatment Period (up to 6 weeks ± allow window):
There will be five (5) visits during the Treatment Period. Baseline/V1 (Day 1 ± 3 days) Visit 2 to Visit 5/EOT (Day 14 to Day 42/EOT) Safety Follow-up Period (Day 49±1 or Day of EOT + 6-8 days)
Twelve(12) eligible subjects with DFUs and are not undergoing dialysis will be enrolled and randomly assigned to receive either ON101 treatment (Arm A) or Placebo (Arm B) for six weeks. Treatment arm allocation will be done through randomization in a double-blind fashion. SoC will be provided throughout the study period.Subjects with DFUs not undergoing dialysis, N = 12 Arm A: ON101 plus SoC, N = 6 Arm B: Placebo plus SoC, N =6 SoC will be provided throughout the study period (from screening to end of treatment). 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.
The study will have three periods, a Screening/Run-in Period, a Treatment Period, and a Safety Follow-up Period.
Screening/Run-in Period (14 days):
Treatment Period (up to 6 weeks ± allow window):
There will be five (5) visits during the Treatment Period. Baseline/V1 (Day 1 ± 3 days) Visit 2 to Visit 5/EOT (Day 14 to Day 42/EOT) Safety Follow-up Period (Day 49±1 or Day of EOT + 6-8 days)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: