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

NCT04457752 | Unknown Phase 4 FDA Drug

• 1 other identifier: HITIDE
• Study Type: interventional
• Target: 124
• Locations: 2 countries
• Sites: 16

Brief Summary

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.

Conditions

Chronic Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• Complete Wound Closure

  \- The percentage of target ulcers achieving complete wound closure in 12 weeks

  1-12 weeks

Secondary Outcomes (5)

• Percentage Wound Area Reduction

  1-12 weeks

• Adverse Events

  1-12 weeks

• Percentage of time wearing offloading boot

  1-12 Weeks

• Pain Scale (The Pain, Enjoyment of Life and General Activity Scale). 0 = no pain , 10 = pain as bad as you can imagine

  TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit

• Changes in bacterial Load

  1-12 Weeks

Study Arms (2)

Dual Layer Amniotic Membrane (DLAM) + SOC

ACTIVE COMPARATOR

DLAM (Up to 10 weekly DLAM applications) + Standard of Care (sharp debridement, offloading, and proper moisture balance).

Biological: Dual Layer Amniotic Membrane (DLAM). Artacent®

Standard of Care

NO INTERVENTION

Standard of Care: sharp debridement, offloading, and proper moisture balance.

Interventions

Dual Layer Amniotic Membrane (DLAM). Artacent® BIOLOGICAL

Artacent® is a double layer of dehydrated amniotic membrane. The amnion is harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean and decellularize the amniotic membrane. The amnion is then folded into a bi-layer with the stromal sides facing outward. The dual layer is dried and cut into various sizes. In the final step the DLAM is terminally sterilized. Atracent®, 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.

Dual Layer Amniotic Membrane (DLAM) + SOC

Eligibility Criteria

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

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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• SerenaGroup, Inc.: lead
• Tides Medical: collaborator

Study Sites (16)

Titan Research

Phoenix, Arizona, 85004, United States

RECRUITING

New Hope Podiatry

Los Angeles, California, 90063, United States

RECRUITING

Royal Research

Pembroke Pines, Florida, 33027, United States

RECRUITING

Pharma Research Associates

Westchester, Florida, 33155, United States

COMPLETED

Regional Infectious Disease and Infusion Center, Inc

La Grange, Georgia, 30240, United States

RECRUITING

Hoosier Foot and Ankle

Fishers, Indiana, 46037, United States

RECRUITING

Serena Group Baton Rouge

Baton Rouge, Louisiana, 70806, United States

RECRUITING

Opelousas Medical Research Consultants, LLC

Opelousas, Louisiana, 70570, United States

RECRUITING

Mount Sinai St. Luke's Hospital

New York, New York, 10025, United States

RECRUITING

Cleveland Foot and Ankle Clinic

Cleveland, Ohio, 44103, United States

RECRUITING

Heal Foundation

Tulsa, Oklahoma, 74146, United States

RECRUITING

The Foot and Ankle Wellness Center of Western Pennsylvania

Ford City, Pennsylvania, 16226, United States

RECRUITING

Armstrong County Memorial Hospital - Wound Clinic

Kittanning, Pennsylvania, 16201, United States

RECRUITING

Martin Foot and Ankle

York, Pennsylvania, 17402, United States

RECRUITING

Mt.Olympus Medical Research

Sugar Land, Texas, 77479, United States

COMPLETED

Clinical Research Management Group

Coto Laurel, 00780, Puerto Rico

COMPLETED

Study Officials

• Thomas E Serena, MD,FACS

  Serena Group, Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas E Serena, MD,FACS

CONTACT

814-688-4000; serena@serenagroups.com

Doug Payne

CONTACT

888-494-4441; dpayne@tidesmedical.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Dual Layer Amniotic Membrane (DLAM). Artacent® Artacent® is a double layer of dehydrated amniotic membrane. The amnion is harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean and decellularize the amniotic membrane. The amnion is then folded into a bi-layer with the stromal sides facing outward. The dual layer is dried and cut into various sizes. In the final step the DLAM is terminally sterilized. Atracent®, 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.

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: September 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 31, 2023
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

PR (1); US (15)