Status:
ACTIVE_NOT_RECRUITING
Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU
Lead Sponsor:
Legacy Medical Consultants
Conditions:
Diabetic Foot Ulcer (DFU)
Venous Leg Ulcers (VLUs)
Eligibility:
All Genders
18+ years
Brief 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 ...
Eligibility Criteria
Inclusion
- Adults ≥18; DFU/VLU/PU; sufficient observable timeline
Exclusion
- Use of other advanced wound products, atypical ulcer etiology (e.g., malignancy, vasculitis); insufficient follow-up
Key Trial Info
Start Date :
September 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT07223281
Start Date
September 25 2025
End Date
December 1 2025
Last Update
November 7 2025
Active Locations (4)
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1
Colorado Foot and Ankle
Colorado Springs, Colorado, United States, 80903
2
Podiatric Surgical Specialists
Clinton Township, Michigan, United States, 48038
3
Advanced Wound Therapy
Tulsa, Oklahoma, United States, 74137
4
Comprehensive Occupational Medicine
Nitro, West Virginia, United States, 25143