Status:
ACTIVE_NOT_RECRUITING
HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU
Lead Sponsor:
Dynamic Medical Services dba Acesso Biologics
Conditions:
Diabetic Foot Ulcer (DFU)
Venous Leg Ulcers (VLUs)
Eligibility:
All Genders
18+ years
Brief Summary
This retrospective multi-site observational cohort study uses electronic health records (EHR) from U.S. wound care centers to evaluate the effectiveness of four amniotic membrane allografts (Acesso DL...
Eligibility Criteria
Inclusion
- Adults ≥18; DFU/VLU/PU; sufficient observability
Exclusion
- Non-study advanced biologic product use within 60 days pre-index; insufficient follow-up
Key Trial Info
Start Date :
October 24 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT07223515
Start Date
October 24 2025
End Date
November 1 2025
Last Update
November 3 2025
Active Locations (2)
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1
Optalis
Novi, Michigan, United States, 48375
2
ProCure Health
Murfreesboro, Tennessee, United States, 37129