Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®)

ClinicalTrials.gov ID: NCT04457752

Public ClinicalTrials.gov record NCT04457752. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 24, 2026, 1:13 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomised Controlled Multicentre Clinical Trial, Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) and Standard of Care Versus Standard of Care Alone in the Healing of Chronic Diabetic Foot Ulcers

Study identification

NCT ID: NCT04457752
Recruitment status: Not listed
Study type: Interventional
Phase: Phase 4
Lead sponsor: SerenaGroup, Inc.; Network
Enrollment: 124 participants

Conditions and interventions

Conditions

Chronic Diabetic Foot Ulcers

Interventions

Dual Layer Amniotic Membrane (DLAM). Artacent® Biological

Biological

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 31, 2020
Primary completion: Feb 28, 2022
Completion: Mar 30, 2023
Last update posted: Nov 3, 2022

2020 – 2023

United States locations

U.S. sites: 15
U.S. states: 11
U.S. cities: 15

Facility	City	State	ZIP	Site status
Titan Research	Phoenix	Arizona	85004	Recruiting
New Hope Podiatry	Los Angeles	California	90063	Recruiting
Royal Research	Pembroke Pines	Florida	33027	Recruiting
Pharma Research Associates	Westchester	Florida	33155	Completed
Regional Infectious Disease and Infusion Center, Inc	La Grange	Georgia	30240	Recruiting
Hoosier Foot and Ankle	Fishers	Indiana	46037	Recruiting
Serena Group Baton Rouge	Baton Rouge	Louisiana	70806	Recruiting
Opelousas Medical Research Consultants, LLC	Opelousas	Louisiana	70570	Recruiting
Mount Sinai St. Luke's Hospital	New York	New York	10025	Recruiting
Cleveland Foot and Ankle Clinic	Cleveland	Ohio	44103	Recruiting
Heal Foundation	Tulsa	Oklahoma	74146	Recruiting
The Foot and Ankle Wellness Center of Western Pennsylvania	Ford City	Pennsylvania	16226	Recruiting
Armstrong County Memorial Hospital - Wound Clinic	Kittanning	Pennsylvania	16201	Recruiting
Martin Foot and Ankle	York	Pennsylvania	17402	Recruiting
Mt.Olympus Medical Research	Sugar Land	Texas	77479	Completed

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04457752, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 3, 2022 · Synced Jul 24, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04457752 live on ClinicalTrials.gov.

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