AMNIOEXCEL® Plus vs A Marketed Comparat… | Clinical Trial

Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California 1, Fresno, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

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.

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.

Other names: Apligraf®

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

Primary outcomes

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.

Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Official study title

A Prospective, Multi-Center, Randomized, Parallel-group Study Comparing AMNIOEXCEL Plus Placental Allograft Membrane to a Marketed Comparator and Standard of Care Procedures in the Management of Diabetic Foot Ulcers

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jun 6, 2018
Registry last updated: Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed