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

Legacy Medical Consultants

Status: Active, not recruiting

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

Study type: Observational

Funder types: Industry

Identifiers

NCT07223281

LMCRWE25

Details and patient eligibility

About

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.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,400 participants in 15 patient groups

Zenith™ + Standard care for DFU

Description:

Patients who received Zenith™ plus standard care for their DFU

Orion™ + Standard care for DFU

Description:

Patients who received Orion™ plus standard care for their DFU

SurGraft FT™ + Standard care for DFU

Description:

Patients who received SurGraft FT™ plus standard care for their DFU

Complete ACA™ + Standard care for DFU

Description:

Patients who received Complete ACA™ plus standard care for their DFU

Standard care alone for DFU

Description:

Patients who received standard care only for their DFU

Zenith™ + Standard care for VLU

Description:

Patients who received Zenith™ plus standard care for their VLU

Orion™ + Standard care for VLU

Description:

Patients who received Orion™ plus standard care for their VLU

SurGraft FT™ + Standard care for VLU

Description:

Patients who received SurGraft FT™ plus standard care for their VLU

Complete ACA™ + Standard care for VLU

Description:

Patients who received Complete ACA™ plus standard care for their VLU

Standard care alone for VLU

Description:

Patients who received standard care only for their VLU

Zenith™ + Standard care for PU

Description:

Patients who received Zenith™ plus standard care for their PU

Orion™ + Standard care for PU

Description:

Patients who received Orion™ plus standard care for their PU

SurGraft FT™ + Standard care for PU

Description:

Patients who received SurGraft FT™ plus standard care for their PU

Complete ACA™ + Standard care for PU

Description:

Patients who received Complete ACA™ plus standard care for their PU

Standard care alone for PU

Description:

Patients who received standard care only for their PU