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WF10

Phase 2

Diabetic Foot Ulcer (DFU) | Small molecule | Metabolic |Co-Diagnostics, Inc.|Last Updated: Oct 22, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04372355Effect of WF10 (TCDO) on HbA1c Values in Diabetic Foot Ulcer PatientsPHASE2 COMPLETED 40Jun 19, 2019Jun 19, 2020Oct 22, 20201 Thailand
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Study Endpoints
Primary Endpoints
HbA1c change at Week 8 in comparison to Baseline
8 weeks

The mean change of HbA1c values between Baseline (Week 0) and Week 8 after the initial WF10 treatment

Secondary Endpoints
HbA1c change at Week 12 in comparison to Baseline
12 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Chlorite-based drug WF10EXPERIMENTALWF10, the chlorite-based drug is infused at a dose of 0.3 ml/Kg BW, after dilution in 300 mL physiological saline, over a period of 3 h. The drug is applied once a week for five
Interventions
NameTypeDescription
WF10DRUGWF10, the chlorite-based drug is infused at a dose of 0.3 ml/Kg BW, after dilution in 300 mL physiological saline, over a period of 3 h. The drug is applied once a week for five subsequent weeks.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients diagnosed with Diabetes Mellitus type II * Patient male or female 18-80 years old * Presence of Diabetic foot ulcer/non-healed stump, starting at least 3 weeks before or infected wound degree 3-4 * HbA1c \> 8.5% * Hematocrit \> 30% Exclusion Criteria: * Kanofsky per...

Countries:Thailand
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