Trial intelligence / Profile preview

Amnio-Maxx for Chronic Diabetic Foot Ulcers

NCT07209475Phase 4

Key facts

Status: Recruiting
Start: Aug 2025
Primary completion: Aug 2026
Countries: 1
Sponsor: Royal Biologics
Modality: Biologic

Drugs: Amnio-Maxx
Conditions: diabetic foot ulcer (DFU)

Overview

Phase 4, randomised, open-label trial in diabetic foot ulcer (DFU) comparing Standard of Care with Amnio-Maxx + SOC (2 arms). Primary endpoints: Complete Ulcer Closure at 12 weeks and Percentage Area Reduction at 12 weeks. Started Aug 2025; status: recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Standard of Care
Amnio-Maxx + SOC

Who it enrols

Adults with Type 1 or 2 diabetes and a Wagner grade 1 or 2 foot ulcer (1-25 cm2) present for 4-52 weeks that failed to heal by 20% during a 2-week run-in period. At least 50% of the population must be > 65 years old.

Endpoints

Primary

Complete Ulcer Closure12 weeks
Percentage Area Reduction12 weeks

Secondary

Numeric Pain Rating Scale12 weeks
Adverse Events12 weeks

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