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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07209475
The ClinicalTrials.gov registry entry for NCT07209475 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 499-participant average among 13 other Diabetic Foot Ulcer (DFU) trials with a reported enrollment target (50% lower). The listed sponsor is Royal Biologics, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 8 study locations spanning 7 distinct geographic areas - top geographies include 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.
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Related
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