AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers

NCT03547635 | Completed Results FDA Device

• 1 other identifier: T-AEPDFU-001
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 7

Brief Summary

This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers (DFUs).

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• The Number of Participants Meeting Criteria of Complete Wound Closure, as Assessed by the Investigator at or Before Week 12 of the Treatment Phase, Which is Confirmed Closed Two Weeks Later.

  Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements.

  Wound closure assessed up to week 12 and confirmed 2 weeks later; only participants with wound closure at or before Week 12 and who maintained closure in follow-up reported

Study Arms (3)

AMNIOEXCEL Plus Amniotic Membrane

EXPERIMENTAL

Other: AMNIOEXCEL Plus Amniotic Membrane

A Marketed Comparator

ACTIVE COMPARATOR

Device: A Marketed Comparator

Standard of Care

OTHER

Other: Standard of Care

Interventions

AMNIOEXCEL Plus Amniotic Membrane OTHER

AMNIOEXCEL Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AMNIOEXCEL Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.

AMNIOEXCEL Plus Amniotic Membrane

A Marketed Comparator DEVICE

bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.

Also known as: Apligraf®

A Marketed Comparator

Standard of Care OTHER

* Coban™ * Conforming gauze * Optifoam® non-adhesive dressing * Cotton Gauze * Normal saline (liquid or gel) * Non-adhering dressings * Steristrips * An offloading boot (Pneumatic Short Leg Walker), as appropriate

Standard of Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have participated in the informed consent process and signed a study-specific informed consent document.
• Be able and willing to comply with study procedures, including study visits, study dressing regimens, and compliance with study required offloading device.
• Be ≥ 21 years of age.
• Have Type I or Type II diabetes mellitus with Investigator-confirmed glycosylated hemoglobin (HbA1c) of ≤ 12%.
• Have at least one diabetic foot ulcer Ulcer size (i.e., area) is \> 1 cm2 and \< 12 cm2.
• Have adequate vascular perfusion of the affected limb

You may not qualify if:

• The subject was previously randomized and treated under this clinical study protocol.
• The study ulcer has features that necessitates surgical operating-room debridement and/or penetrates to capsule/tendon/bone.
• The subject is unable to safely ambulate with the use of a study required offloading boot.
• The subject has suspected or confirmed gangrene or wound infection of the study ulcer.
• The subject has suspected or confirmed osteomyelitis.
• In the opinion of the Investigator, the subject has received or is scheduled to receive during study participation, a medication or treatment which is known to interfere with or affect the rate and quality of wound healing
• The subject has a history of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or has had chemotherapy prior to signing the Informed Consent Form for trial participation.
• The subject is currently pregnant or is actively trying to conceive.
• In the opinion of the Investigator, the subject is unable to comply with the treatment regimen
• In the opinion of the Investigator, the subject has a history of, or is currently diagnosed with, any illness or condition, other than diabetes, that could interfere with wound healing.
• In the opinion of the Investigator, the subject has a condition that could inhibit wound healing.
• The subject has ulcers secondary to a disease other than diabetes.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (7)

California 1

Fresno, California, 93710, United States

Location

California 3

Fresno, California, 93710, United States

Location

California 2

Los Angeles, California, 90063, United States

Location

Georgia 1

Gainesville, Georgia, 30501, United States

Location

Illinois 1

Springfield, Illinois, 62704, United States

Location

New Jersey 1

Toms River, New Jersey, 08753, United States

Location

Texas 1

San Antonio, Texas, 78229, United States

Location

Related Publications (3)

• Snyder RJ, Shimozaki K, Tallis A, Kerzner M, Reyzelman A, Lintzeris D, Bell D, Rutan RL, Rosenblum B. A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer. Wounds. 2016 Mar;28(3):70-7.

  PMID: 26978860 BACKGROUND

• Martinson M, Martinson N. A comparative analysis of skin substitutes used in the management of diabetic foot ulcers. J Wound Care. 2016 Oct 1;25(Sup10):S8-S17. doi: 10.12968/jowc.2016.25.Sup10.S8.

  PMID: 27681811 BACKGROUND

• Snyder RJ, Cardinal M, Dauphinee DM, Stavosky J. A post-hoc analysis of reduction in diabetic foot ulcer size at 4 weeks as a predictor of healing by 12 weeks. Ostomy Wound Manage. 2010 Mar 1;56(3):44-50.

  PMID: 20368673 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Jessica Knowlton, Sr Mgr, Clinical Research & PMCF Strategy
• Organization: Integra LifeSciences

jessica.knowlton@integralife.com

609-325-0111

Study Officials

• Jessica Knowlton, MS CRA

  Integra LifeSciences Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers (DFUs).

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 6, 2018
• Study Start: May 3, 2018
• Primary Completion: February 26, 2019
• Study Completion: February 26, 2019
• Last Updated: July 20, 2020
• Results First Posted: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)