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SkinTE for Wagner grade 2 diabetic foot ulcers
NCT05372809Phase 3
Key facts
- Status
- Terminated
- Start
- Apr 2022
- Primary completion
- Feb 2024
- Countries
- 1
- Sponsor
- PolarityBio
- Modality
- Implantable Devices, Implantable Hydrogels, Cell Therapies
- Drugs
- SkinTE
- Conditions
- diabetic foot ulcer (DFU)
01
Overview
Phase 3, randomised, single-blind trial of SkinTE in diabetic foot ulcer (DFU) (2 arms), sponsored by PolarityBio. Primary endpoint: Incidence of index ulcers closed at 24 weeks. Started Apr 2022; status: terminated.
02
Design
2 arms- Study design
- RandomizedSingle-blind
SkinTE
SkinTE + Standard of Care
Control
Standard of Care alone
03
Who it enrols
Adults with Type 1 or 2 Diabetes Mellitus and a Wagner grade 2 diabetic foot ulcer (1-10 cm2) present for at least 4 weeks, with adequate circulation and no severe infection or gangrene.
04
Endpoints
Primary
Incidence of index ulcers closed
Secondary
Percent area reduction
Incidence of index ulcers closed at 12 weeks
Time to closure
Wound Quality of Life Questionnaire
Wound infection
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