AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers

A Prospective, Multi-Center, Randomized Controlled, Parallel Group, Trial Evaluating the Use of AmnioExcel Plus Placental Allograft Membrane for the Management of Diabetic Foot Ulcers

This is a prospective, multicenter, randomized, parallel-group Trial comparing the outcomes associated with the use of AmnioExcel® Plus Placental Allograft Membrane (AmnioExcel® Plus) used in conjunction with Standard of Care (SOC) compared to SOC alone in the management of diabetic foot ulcers (DFUs).

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Other: AmnioExcel Plus Amniotic Membrane; Other: Standard of Care

Detailed Description

This study will have three (3) phases: (1) a Screening Phase, (2) a Treatment Phase, and (3) a Follow-up Phase. Subjects will be seen weekly in the Screening and Treatment Phases.

Subjects will be seen weekly in the Screening and Treatment Phases. Subjects who achieve confirmed wound closure during the Treatment Phase will be entered into the Follow-up Phase and will return to the site four (4) weeks following that confirmation visit.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have participated in the informed consent process and signed a study-specific informed consent document
• Be willing to comply with study procedures, including study visits, and compliance with study required off-loading/protective device for the duration of the study
• Be at least 18 years of age
• If female and of child-bearing potential, must not be pregnant. To document pregnancy status, subject statement is acceptable
• Have Type II or Type II diabetes mellitus with investigator-confirmed glycosylated hemoglobin (HbA1c) of less than or equal to 12% within 3 months prior to Screening Visit

• Have at least one diabetic foot ulcer that meets ALL the following criteria:

  1. Ulcer which has been in existence for a minimum of four weeks, prior to signing the Informed Consent Form allowing trial participation
  2. Ulcer is a partial or full thickness diabetic foot ulcer without capsule/tendon/bone exposure
  3. Ulcer does not have tunneling, undermining, or sinus tracts that necessitates surgical OR debridement and/or penetrates to capsule/tendon/bone
  4. Ulcer is located on the foot or ankle (with no portion above the top of the malleolus)
  5. Ulcer size (area) is greater than equal to 1 cm2 and less than equal to 12 cm2 post-debridement

• Have a minimum 4cm margin between the qualifying study ulcer and any other ulcer on that same foot, post-debridement

  (a) If the subject has more than one ulcer that meets eligibility criteria, the ulcer designated as the study ulcer will be at the discretion of the investigator

• Have adequate vascular perfusion of the affected limb as defined by at least one of the following within the past 60 days:

  1. Ankle-Brachial Index (ABI) greater than equal to 0.7 and less than equal to 1.2, performed within 60 days of screening,
  2. Toe pressure (plethysmography) > 40 mmHg at time of screening, or
  3. TcPO2 > 50 mmHg at time of screening
• Be willing and able to maintain required applicable dressing changes as well as study required off-loading/protective device for the duration of the study
• Have a study wound severity Wagner I or II

Exclusion Criteria:

• Previously randomized and treated under this clinical study protocol
• Patients with a known history of poor compliance with medical treatments
• Suspected or confirmed gangrene or ulcer infection of the study ulcer or is receiving systemic/IV antibiotics at the time of randomization
• Suspected or confirmed osteomyelitis of the foot with the study ulcer
• Participated in another clinical trial involving a device or a systemically administered investigational study drug/treatment within 28 days of randomization
• Received within 28 days of signing Informed Consent Form, 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 ulcer healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy, dialysis, radiation therapy to the foot, vascular surgery, angioplasty, or thrombolysis)
• History of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or has had chemotherapy (i.e., systemic steroids, anti-rheumatics, TNF inhibitors, active chemotherapy, immunosuppressive therapy, autoimmune disease therapy) within 12 months prior to signing Informed Consent Form allowing trial participation
• 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 ulcer healing (e.g., end-stage renal disease, severe malnutrition, liver disease, aplastic anemia, connective tissue disorder, acquired immune deficiency syndrome, HIV positive, or sickle cell anemia)
• In the opinion of the investigator, the subject has unstable Charcot foot or Charcot with bony prominence that could inhibit ulcer healing
• Have ulcers secondary to a disease other than diabetes (e.g., vasculitis, neoplasms, or hematological disorders)
• In the opinion of the investigator, the subject has excessive lymphedema that could interfere with off-loading and/or ulcer healing
• Study Ulcer has received ulcer dressings that included growth factors, engineered tissues, or skin substitutes within 28 days of randomization, or is scheduled to receive such treatment during the study (e.g., Regranex, Dermagraft, Apligraf, EpiFix, Grafix, GraftJacket, OASIS, Omnigraft, or Integra BMWD)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AmnioExcel Plus Amniotic Membrane + Standard of Care; 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 in the 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. Standard of care includes the following: Coban™; Conforming gauze; Optifoam® non-adhesive dressing; Xtrasorb® for highly exudated wounds; Cotton Gauze; Normal saline (liquid or gel); Non-adhering dressings; Steristrips; Offloading boot, as appropriate	Other: AmnioExcel Plus Amniotic Membrane; AmnioExcel® Plus will be applied weekly, in conjunction with SOC, if the ulcer remains open, or up to and including Week 11, whichever comes first.; Other: Standard of Care; The dressings, materials, and appliances used in accordance with institutional protocol or professional clinical judgement.
ACTIVE_COMPARATOR: Standard of Care; Coban™; Conforming gauze; Optifoam® non-adhesive dressing; Xtrasorb® for highly exudated wounds; Cotton Gauze; Normal saline (liquid or gel); Steristrips; Offloading boot, as appropriate	Other: Standard of Care; The dressings, materials, and appliances used in accordance with institutional protocol or professional clinical judgement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complete wound closure	Number of wounds with complete wound closure as assessed by the investigator. Complete wound closure is defined as 100% re-epithelialization of the ulcer surface without detectable exudate.	Up to 12 weeks of treatment

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Study Director: Yi Arnold, PhD, Integra LifeSciences

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2021
• Primary Completion (ANTICIPATED): February 1, 2024
• Study Completion (ANTICIPATED): June 1, 2024

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (ACTUAL): August 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: diabetic foot; diabetes mellitus; diabetes complications
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: T-AEPDFU-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No