Artacent Amniotic Tissue for Treatment of Chronic Lower Extremity Diabetic Ulcers.

NCT07219004 | Completed

• 1 other identifier: POC-AC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period.

Conditions

Lower Extremity Chronic Ulcers in Diabetics; Diabetic Foot Ulcer (DFU)

Keywords

Diabetic Foot Ulcers; Chronic foot ulcers; Plantar Ulcers; Lower Extremity Ulcers; Amniotic Tissues; HCT/P; 361 products; Q4190

Outcome Measures

Primary Outcomes (1)

• Rate of wound closure by percent of complete epithelialization

  complete wound closure measured by 100% epithelialization

  12 weeks

Secondary Outcomes (1)

• Percent area reduction

  12 weeks

Study Arms (1)

Artacent-AC

EXPERIMENTAL

Artacent AC®is a HCT/P regulated solely as a "361 Product" and meets all criteria in 21 CFR 1271.10(a). The amnion and chorion layers are harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean the amniotic and chorion membranes. A Tri-Layered Amniotic Membrane (TLAM) is then formed by adding two outer layers of amnion with the stromal sides facing outward, separated by a middle chorion layer. TLAM is dried and cut into various sizes, packaged, and terminally sterilized. Artacent AC, like all other placental-derived products, is FDA cleared for homologous use through the 361 pathway. It is indicated for non-healing ulcers applied to a debrided, clean and uninfected ulcers as a wound cover.

Other: amniotic membrane

Interventions

amniotic membrane OTHER

The intervention is a trial-layer human amnion/chorion/amnion composite graft

Also known as: Chorion, Q4190, Amnion

Artacent-AC

Eligibility Criteria

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

You may qualify if:

• Subjects will be eligible to participate in the study if all the following conditions exist:
• Potential subjects are required to meet all the following criteria for enrollment into the study.
• Subjects must be at least 18 years of age or older,
• Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
• At entry subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the MolecuLight Imaging HCT/P 361 .
• The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
• The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
• The target ulcer must be full thickness without exposed bone.
• The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
• ABI between 0.7 and ≤ 1.3;
• TBI ≥ 0.6;
• TCOM ≥ 40 mmHg;
• PVR: biphasic.

You may not qualify if:

• Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
• The subject must consent to using the prescribed off-loading method for the duration of the study.
• The subject must agree to attend the weekly study visits required by the protocol.
• The subject must be willing and able to participate in the informed consent process.
• Subjects will be excluded from participation in the study if any of the following conditions exist:
• A subject known to have a life expectancy of \< 6 months is excluded.
• The subject is excluded if the target ulcer is not secondary to diabetes.
• If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
• If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
• A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
• A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
• The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
• A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
• If a subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit he/she is excluded.
• The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the subject received SOC.

Sponsors & Collaborators

• Tides Medical: lead
• Serena Group: collaborator

Study Sites (5)

Three Rivers Wound and Hyperbaric Center

North Port, Florida, 34289, United States

Location

Serena Group Reseach Center

Buffalo, New York, 14203, United States

Location

Serena Group

Monroeville, Pennsylvania, 15146, United States

Location

The Serena Group Austin Research Center

Austin, Texas, 78701, United States

Location

El Campo Memorial Advanced Wound Care Clinic

El Campo, Texas, 77437, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer; Leg Ulcer

Interventions

Biological Dressings; cancer procoagulant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Officials

• Thomas Serena, MD

  Serena Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 21, 2025
• Study Start: March 3, 2023
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)