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RENEW: Lavior Gel vs Solosite for Diabetic Foot Ulcers
NCT05607979Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2022
- Primary completion
- May 2024
- Countries
- 1
- Sponsor
- Lavior Pharma
- Modality
- Hydrogel Systems, Device-based Delivery
- Conditions
- diabetic foot ulcer (DFU)
01
Overview
Phase 3, randomised, double-blind trial of Lavior Diabetic Wound Gel in diabetic foot ulcer (DFU) (2 arms), sponsored by Lavior Pharma. Primary endpoint: Time to achieve complete wound closure at 60 days. Started Dec 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Lavior Diabetic Wound Gel
Daily application of Lavior Diabetic Wound Gel
Solosite Gel
Daily application of Smith & Nephew Solosite Gel
03
Who it enrols
Adult patients with diabetes mellitus and a foot ulcer (minimum area 0.49 cm²) are eligible. Patients with gangrene, untreatable peripheral arterial disease, malignancy of the wound, or those using other hydrogels are excluded.
04
Endpoints
Primary
Time to achieve complete wound closure
Secondary
Incidence of wound closures
Recurrence of wound opening
Change in wound depth over time
Change in wound surface area over time
Change in Pain Scores over time
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