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

• Status: Recruiting
• Trial end date: 2022-03-01

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

• Phase: N/A

Details

• Lead Sponsor: Oneness Biotech Co., Ltd.