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NCT07223281 · ClinicalTrials.gov registry record
Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU
A clinical trial of Diabetic Foot Ulcer (DFU) and Venous Leg Ulcers (VLUs), sponsored by Legacy Medical Consultants.
- Active
- Registry status
- 2,400
- Enrollment target
- 4
- Study locations
NCT07223281: Active study of Diabetic Foot Ulcer (DFU) and Venous Leg Ulcers (VLUs), sponsored by Legacy Medical Consultants.
NCT07223281 is a study of Diabetic Foot Ulcer (DFU) and Venous Leg Ulcers (VLUs) that is active but no longer recruiting, run by Legacy Medical Consultants. The registered enrollment target is 2,400 participants, above the 333-participant average among 13 other Diabetic Foot Ulcer (DFU) trials with a reported enrollment target (621% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07223281, a study of Diabetic Foot Ulcer (DFU) and Venous Leg Ulcers (VLUs), is active but no longer recruiting, sponsored by Legacy Medical Consultants.
- ACTIVE NOT RECRUITING
- Registry status
- 2,400 participants
- Enrollment target
- 4
- Study locations
Study Summary
This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone. The study will use complete electronic health records (EHR) from multiple wound care centers across the United States (2022-2025) to generate study data for product-treated and propensity score-matched standard care cohorts for each product-indication combination. The overall study comprises 12 parallel sub-studies (one for each product-wound type combination), each aiming to answer whether adding the product improves healing outcomes versus standard care alone in that indication. The primary endpoint is the proportion of wounds achieving complete closure within 12 weeks, with subgroup analyses by wound severity measures, age groups, and number of product applications. Secondary outcomes are time-to-healing, early wound improvement (≥50% reduction in wound area by 4 weeks), wound-related complications, and subgroup analyses.
Primary Outcome
Proportion of index wounds with 100% epithelialization, no drainage or dressings; confirmation on ≥1 follow-up within 60 days
Conditions Studied
Study Locations (4)
Colorado
- Colorado Foot and Ankle - Colorado Springs
Michigan
- Podiatric Surgical Specialists - Clinton Township
Oklahoma
- Advanced Wound Therapy - Tulsa
West Virginia
- Comprehensive Occupational Medicine - Nitro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,400 participants |
| Start Date | 2025-09-25 |
| Est. Completion | 2025-12 |
What the registry record for NCT07223281 still lists
NCT07223281 is an observational study that tracks outcomes without assigning an intervention. Its 2,400 participants enrollment target places it among the larger protocols in the corpus, above the 333-participant average among 13 other Diabetic Foot Ulcer (DFU) trials with a reported enrollment target (621% higher).
The record links to 3 conditions, with Diabetic Foot Ulcer (DFU) appearing as the primary indexed condition, and to 0 interventions.
NCT07223281 reports a single indexed study location in Colorado, Michigan, Oklahoma.
Frequently Asked Questions
What is clinical trial NCT07223281 about?
NCT07223281 is a clinical study titled "Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU". This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone. The study will use complete electronic health records (EHR) from multiple wound...
What is the current status of trial NCT07223281?
This trial is currently active not recruiting. The enrollment target is 2,400 participants. The study started on 2025-09-25. Estimated completion is 2025-12.
What conditions does trial NCT07223281 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer.
Who is sponsoring clinical trial NCT07223281?
This trial is sponsored by Legacy Medical Consultants, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07223281 being conducted?
This trial has 4 study locations across Colorado, Michigan, Oklahoma, West Virginia. 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 NCT07223281's enrollment target sits among peer trials
2,400 1st of 13 higher than 13 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
-
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