A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers

ConditionsDiabetic Foot Foot Ulcer Ulcer Foot DFU Foot Ulcer Due to Type 2 Diabetes Mellitus Foot Ulcer Due to Type 1 Diabetes Mellitus Diabetic Foot Ulcer

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorApplied Biologics, LLC

About this trial

A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.

Eligibility criteria

Qualifiers

The potential subject must be at least 18 years of age or older.

The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.

If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the CAMPX study.

The potential subject must consent to using the prescribed offloading method for the duration of the study.

Disqualifiers

The potential subject is known to have a life expectancy of < 6 months.

The potential subject's target ulcer is not secondary to diabetes.

The target ulcer is infected or there is cellulitis in the surrounding skin.

The target ulcer exposes tendon or bone.

Trial design

Treatments tested in this trial

XWRAP

Treatment groups

60 Participants

are divided into 1 treatment group

Sponsors and collaborators

Applied Biologics, LLC

Lead sponsor

SerenaGroup, Inc.

Collaborator

Source ClinicalTrials.gov