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

NCT07223281 | Active Not Recruiting

• 1 other identifier: LMCRWE25
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 4

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 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.

Conditions

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

Keywords

real world evidence; wound healing

Outcome Measures

Primary Outcomes (1)

• Complete wound closure at 12 Weeks

  Proportion of index wounds with 100% epithelialization, no drainage or dressings; confirmation on ≥1 follow-up within 60 days

  From index visit to 12 weeks post-index

Secondary Outcomes (3)

• Time to complete wound closure

  From index visit up to 24 months post-index

• ≥50% wound area reduction at 4 weeks

  From index visit to 4 weeks post-index

• Wound-related complications

  From index visit up to 24 months post-index

Study Arms (15)

Zenith™ + Standard care for DFU

Patients who received Zenith™ plus standard care for their DFU

Orion™ + Standard care for DFU

Patients who received Orion™ plus standard care for their DFU

SurGraft FT™ + Standard care for DFU

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

Complete ACA™ + Standard care for DFU

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

Standard care alone for DFU

Patients who received standard care only for their DFU

Zenith™ + Standard care for VLU

Patients who received Zenith™ plus standard care for their VLU

Orion™ + Standard care for VLU

Patients who received Orion™ plus standard care for their VLU

SurGraft FT™ + Standard care for VLU

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

Complete ACA™ + Standard care for VLU

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

Standard care alone for VLU

Patients who received standard care only for their VLU

Zenith™ + Standard care for PU

Patients who received Zenith™ plus standard care for their PU

Orion™ + Standard care for PU

Patients who received Orion™ plus standard care for their PU

SurGraft FT™ + Standard care for PU

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

Complete ACA™ + Standard care for PU

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

Standard care alone for PU

Patients who received standard care only for their PU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with DFU, VLU, or PU

You may qualify if:

• Adults ≥18; DFU/VLU/PU; sufficient observable timeline

You may not qualify if:

• Use of other advanced wound products, atypical ulcer etiology (e.g., malignancy, vasculitis); insufficient follow-up

Sponsors & Collaborators

• Legacy Medical Consultants: lead

Study Sites (4)

Colorado Foot and Ankle

Colorado Springs, Colorado, 80903, United States

Location

Podiatric Surgical Specialists

Clinton Township, Michigan, 48038, United States

Location

Advanced Wound Therapy

Tulsa, Oklahoma, 74137, United States

Location

Comprehensive Occupational Medicine

Nitro, West Virginia, 25143, United States

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Diabetic Foot; Pressure Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: October 31, 2025
• Study Start: September 25, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-10

Locations

US (4)