A Prospective Multi-ceter Clinical Trail. Evaluating the Efficacy of Tri-layer Amnion/Chorion/Amnion (Artacent-AC) and Standard of Care in the Treatment of Chronic Lower Extremity Diabetic Ulcers.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tides Medical
- Enrollment
- 30
- Locations
- 5
- Primary Endpoint
- Rate of wound closure by percent of complete epithelialization
Study Overview
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.
Detailed Description
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. During this trial the patient will undergo a screening period where SOC is used to see if the patient will respond and heal > 20% of the surface area in 2 weeks. if the patient can not heal more than 20% in two week the patient then will receive a trial-layered human amnion/chorion/amnion composite graft weekly for 12 week and precent wound area reduction and complete wound healing will be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
- •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.
- •Exclusion Criteria:
- •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.
Arms & Interventions
Artacent-AC
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.
Intervention: amniotic membrane (Other)
Outcomes
Primary Outcomes
Rate of wound closure by percent of complete epithelialization
Time Frame: 12 weeks
complete wound closure measured by 100% epithelialization
Secondary Outcomes
- Percent area reduction(12 weeks)