NCT07209475

Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.

A Randomized Controlled Multicenter Trial, Examining the Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Royal Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch.

Conditions

• Diabetic Foot Ulcer (DFU)
• Amnio-Maxx

Interventions

Type	Name	Description
BIOLOGICAL	Amnio-Maxx® Dual Layer Amnion Patch	Application of Amnio-Maxx® Dual Layer Amnion Patch
OTHER	Standard of Care (Investigator Choice)	Cleansing, debridement, wound documentation, off-loading

Timeline

• Start date: 2025-08-14
• Primary completion: 2026-08-14
• Completion: 2026-08-14
• First posted: 2025-10-07
• Last updated: 2025-10-07

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study