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Status:

COMPLETED

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

Lead Sponsor:

Tides Medical

Collaborating Sponsors:

Serena Group

Conditions:

Lower Extremity Chronic Ulcers in Diabetics

Diabetic Foot Ulcer (DFU)

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

March 3 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 27 2023

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT07219004

Start Date

March 3 2023

End Date

September 27 2023

Last Update

October 21 2025

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Three Rivers Wound and Hyperbaric Center

North Port, Florida, United States, 34289

2

Serena Group Reseach Center

Buffalo, New York, United States, 14203

3

Serena Group

Monroeville, Pennsylvania, United States, 15146

4

The Serena Group Austin Research Center

Austin, Texas, United States, 78701