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

Status unconfirmed · Phase 4

Conditions studied: Chronic Diabetic Foot Ulcers

In brief

A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) and Standard of Care versus Standard of Care alone in the healing Chronic Diabetic Foot Ulcers. Multi-center, open label, randomized controlled trial. Study is estimated to require 12 months from first subject enrolled to last subject visit.

Key facts

Study ID

NCT04457752

Run by

SerenaGroup, Inc.

People needed

124

Starts

2020-09-01

Expected to finish

2023-03-31

Last updated by the study team

2022-11-04

Who can join

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

You may qualify if…

• Subjects must be at least 18 years of age or older,
• Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
• At randomization 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 Tissue Analytics photographic planimetry App.
• 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 30 days prior to randomization.
• 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…

• 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 40% or more during the 4-week screening phase: the 4 weeks from the initial screening visit (SV1) to the TV-1/randomization 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.
• A Subject is excluded if the MolecuLight Device shows a positive fluorescence image in the wound bed on TV1

Where it is running

• Titan Research — Phoenix, Arizona, United States (enrolling)
• New Hope Podiatry — Los Angeles, California, United States (enrolling)
• Royal Research — Pembroke Pines, Florida, United States (enrolling)
• The Foot and Ankle Wellness Center of Western Pennsylvania — Ford City, Pennsylvania, United States (enrolling)
• Armstrong County Memorial Hospital - Wound Clinic — Kittanning, Pennsylvania, United States (enrolling)
• Martin Foot and Ankle — York, Pennsylvania, United States (enrolling)
• Regional Infectious Disease and Infusion Center, Inc — La Grange, Georgia, United States (enrolling)
• Hoosier Foot and Ankle — Fishers, Indiana, United States (enrolling)
• Serena Group Baton Rouge — Baton Rouge, Louisiana, United States (enrolling)
• Opelousas Medical Research Consultants, LLC — Opelousas, Louisiana, United States (enrolling)
• Mount Sinai St. Luke's Hospital — New York, New York, United States (enrolling)
• Cleveland Foot and Ankle Clinic — Cleveland, Ohio, United States (enrolling)
• Heal Foundation — Tulsa, Oklahoma, United States (enrolling)
• Pharma Research Associates — Westchester, Florida, United States
• Mt.Olympus Medical Research — Sugar Land, Texas, United States
• Clinical Research Management Group — Coto Laurel, Puerto Rico

Full record on ClinicalTrials.gov

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