NCT06681428

Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers

A Multi-Center, Randomized Controlled Clinical Investigation Evaluating an Amnion/Chorion/Amnion Allograft, Amnion/Chorion Allograft, And/or an Amnion/Amnion Allograft Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Tides Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.

Conditions

• Diabetic Foot Ulcer (DFU)
• Chronic Foot Ulcers

Interventions

Type	Name	Description
OTHER	Allograft	Placental-based Allografts

Timeline

• Start date: 2024-11-14
• Primary completion: 2026-11-18
• Completion: 2026-11-18
• First posted: 2024-11-08
• Last updated: 2025-02-10

Locations

9 sites across 1 country: United States