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Clinical Trials in the USA / NCT07223281
Active, not recruiting Observational

Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU

NCT07223281 · tracked via the Priya Life Science USA tracker
Sponsor
Legacy Medical Consultants
Phase
Observational
Started
2025-09-25
Last updated
2025-11-10

Condition(s) studied

Diabetic Foot Ulcer (DFU)Venous Leg Ulcers (VLUs)Pressure Ulcers, Bedsores, Decubitus Ulcer

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults ≥18; DFU/VLU/PU; sufficient observable timeline Exclusion Criteria: * Use of other advanced wound products, atypical ulcer etiology (e.g., malignancy, vasculitis); insufficient follow-up

Primary outcome measure(s)

  • Complete wound closure at 12 Weeks — From index visit to 12 weeks post-index
    Proportion of index wounds with 100% epithelialization, no drainage or dressings; confirmation on ≥1 follow-up within 60 days

Trial sites (4)

FacilityCityRegionStatus
Colorado Foot and Ankle Colorado Springs Colorado
Podiatric Surgical Specialists Clinton Township Michigan
Advanced Wound Therapy Tulsa Oklahoma
Comprehensive Occupational Medicine Nitro West Virginia

More Legacy Medical Consultants trials in the USA

Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management Active, not recruiting

Other trials for the same condition

Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs Recruiting
Assessing Connected-Health, Pressure-Monitoring Technology for Improving Compression Therapy in Venous Leg Ulcer Treatment Recruiting
Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing Active, not recruiting
HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU Active, not recruiting
Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07223281 on ClinicalTrials.gov ↗ ← All trials in the USA