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

Completed · Not applicable

Conditions studied: Lower Extremity Chronic Ulcers in Diabetics, Diabetic Foot Ulcer (DFU)

In brief

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.

Key facts

Study ID

NCT07219004

Run by

Tides Medical

People needed

30

Starts

2023-03-03

Expected to finish

2023-09-27

Last updated by the study team

2025-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
• 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.

You may not qualify if…

• 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.
• A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
• Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
• A potential subject with end stage renal disease requiring dialysis is excluded.
• A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days is excluded.
• A subject who in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
• A Subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded.

Where it is running

• Three Rivers Wound and Hyperbaric Center — North Port, Florida, United States
• Serena Group Reseach Center — Buffalo, New York, United States
• Serena Group — Monroeville, Pennsylvania, United States
• The Serena Group Austin Research Center — Austin, Texas, United States
• El Campo Memorial Advanced Wound Care Clinic — El Campo, Texas, United States

Full record on ClinicalTrials.gov

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