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NCT07209475 · ClinicalTrials.gov registry record · Phase 4
Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
A Phase 4 study of Diabetic Foot Ulcer (DFU) and Amnio-Maxx, sponsored by Royal Biologics.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 248
- Enrollment target
- 8
- Study locations
NCT07209475: Recruiting Phase 4 study of Diabetic Foot Ulcer (DFU) and Amnio-Maxx, sponsored by Royal Biologics.
NCT07209475 is a Phase 4 study of Diabetic Foot Ulcer (DFU) and Amnio-Maxx that is actively recruiting participants, run by Royal Biologics. The registered enrollment target is 248 participants, below the 499-participant average among 13 other Diabetic Foot Ulcer (DFU) trials with a reported enrollment target (50% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07209475, a Phase 4 study of Diabetic Foot Ulcer (DFU) and Amnio-Maxx, is actively recruiting participants, sponsored by Royal Biologics.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 248 participants
- Enrollment target
- 8
- Study locations
Study 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 Studied
Interventions
- BIOLOGICAL Amnio-Maxx® Dual Layer Amnion Patch
- OTHER Standard of Care (Investigator Choice)
Study Locations (8)
Texas
- VAST Clinical Research Carrollton Foot Center - Carrollton
- Elite Foot & Ankle Associates - Spicewood
California
- Lion Heart Clinical Research - Burbank
Florida
- Royal Research South - Miami
Georgia
- Denali Health Atlanta, LLC - Stone Mountain
Nebraska
- SerenaGroup Research Center - Omaha
New York
- Suffolk Foot and Ankle - East Patchogue
Oklahoma
- Wound Care of Tulsa - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2025-08-14 |
| Est. Completion | 2026-08-14 |
| Phase | Phase 4 |
What NCT07209475 shows while recruiting
NCT07209475 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, below the 499-participant average among 13 other Diabetic Foot Ulcer (DFU) trials with a reported enrollment target (50% lower).
The record links to 2 conditions, with Diabetic Foot Ulcer (DFU) appearing as the primary indexed condition, and to 2 interventions - of which Amnio-Maxx® Dual Layer Amnion Patch is the first listed.
NCT07209475 lists 8 locations in 7 states (Texas, California, Florida).
Frequently Asked Questions
What is clinical trial NCT07209475 about?
NCT07209475 is a clinical study titled "Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.". 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.
What is the current status of trial NCT07209475?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 248 participants. The study started on 2025-08-14. Estimated completion is 2026-08-14.
What conditions does trial NCT07209475 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer (DFU), Amnio-Maxx.
What interventions are being tested in trial NCT07209475?
The interventions under investigation include: Amnio-Maxx® Dual Layer Amnion Patch (BIOLOGICAL), Standard of Care (Investigator Choice) (OTHER).
Who is sponsoring clinical trial NCT07209475?
This trial is sponsored by Royal Biologics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07209475 being conducted?
This trial has 8 study locations across California, Florida, Georgia, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcer (DFU)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07209475's enrollment target sits among peer trials
248 6th of 13 higher than 8 of 13 other Diabetic Foot Ulcer (DFU) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer (DFU) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
RECRUITING · Phase 4
-
A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
RECRUITING · Phase 4
-
Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
RECRUITING · NA
-
CARE-D-FOOT-Nav Pilot
RECRUITING · NA
-
A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs
RECRUITING · NA
-
CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
RECRUITING · NA
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