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NCT07223281

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

NCT ID: NCT07223281

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-25

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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real world evidence wound healing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Zenith™ + Standard care for DFU

Patients who received Zenith™ plus standard care for their DFU

No interventions assigned to this group

Orion™ + Standard care for DFU

Patients who received Orion™ plus standard care for their DFU

No interventions assigned to this group

SurGraft FT™ + Standard care for DFU

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

No interventions assigned to this group

Complete ACA™ + Standard care for DFU

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

No interventions assigned to this group

Standard care alone for DFU

Patients who received standard care only for their DFU

No interventions assigned to this group

Zenith™ + Standard care for VLU

Patients who received Zenith™ plus standard care for their VLU

No interventions assigned to this group

Orion™ + Standard care for VLU

Patients who received Orion™ plus standard care for their VLU

No interventions assigned to this group

SurGraft FT™ + Standard care for VLU

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

No interventions assigned to this group

Complete ACA™ + Standard care for VLU

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

No interventions assigned to this group

Standard care alone for VLU

Patients who received standard care only for their VLU

No interventions assigned to this group

Zenith™ + Standard care for PU

Patients who received Zenith™ plus standard care for their PU

No interventions assigned to this group

Orion™ + Standard care for PU

Patients who received Orion™ plus standard care for their PU

No interventions assigned to this group

SurGraft FT™ + Standard care for PU

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

No interventions assigned to this group

Complete ACA™ + Standard care for PU

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

No interventions assigned to this group

Standard care alone for PU

Patients who received standard care only for their PU

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Legacy Medical Consultants

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Colorado Foot and Ankle

Colorado Springs, Colorado, United States

Site Status

Podiatric Surgical Specialists

Clinton Township, Michigan, United States

Site Status

Advanced Wound Therapy

Tulsa, Oklahoma, United States

Site Status

Comprehensive Occupational Medicine

Nitro, West Virginia, United States

Site Status

Countries

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United States

References

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Kahoun, J., Gorenstein, S., & Gillette, B. (2025). Real-World Performance of Amniotic Membrane Allografts for Chronic Wounds: Multi-Site Results from a Retrospective EHR Study. https://doi.org/10.5281/zenodo.17504472

Reference Type RESULT

Other Identifiers

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LMCRWE25

Identifier Type: -

Identifier Source: org_study_id