Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care

ConditionsDiabetic Foot Ulcer Diabetic Foot Foot Ulcer Ulcer Foot DFU

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorApplied Biologics, LLC

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

SLAM + SOC
Other intervention
Weekly Treatment visits for 12 weeks begin at day 0. SLAM applications with SOC until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
SOC
Other intervention
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Treatment groups

124 Participants

are divided into 2 treatment groups

Group A: Standard of CareActive comparator 1 intervention

Group B: SLAM + SOCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

1-12 Weeks

Secondary outcomes

The time to heal for target ulcers.

Time to closure will be determined for each treatment group and compared to SOC.

Time frame

1-12 weeks

Wound Area Reduction

Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry, using MolecuLight Imaging Device, and physical examination.

Time frame

1-12 weeks

Adverse Events

Incidence of adverse events will be evaluated weekly from TV-1 to the healing confirmation visit (HCV).

Time frame

1-14 Weeks

Change in pain in the target ulcer

Change in pain in the target ulcer assessed using the PEG (pain, enjoyment in life, and general pain) scale. \[Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit\].

Time frame

1-12 weeks

Other outcomes

Percentage of target ulcers achieving complete wound closure

Percentage of target ulcers achieving complete wound closure in 12 weeks for subjects 65 years of age or older.

Time frame

1-12 weeks

Changes in chronic inhibitory bacterial load

Changes in chronic inhibitory bacterial load (CIBL) measured using fluorescence imaging.

Time frame

1-14 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Applied Biologics, LLC

Lead sponsor

SerenaGroup, Inc.

Collaborator

Source ClinicalTrials.gov

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