Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers

ConditionsDiabetic Foot Ulcer Foot Foot Ulcer Diabetic Foot Ulcer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAxolotl Biologix

About this trial

The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

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 1.0 cm2 and a maximum surface area of 5.0 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 offloading 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

Standard of Care
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.
Axolotl DualGraft + SOC
Other intervention
Participants will receive weekly applications of Axolotl DualGraft and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Standard of CareActive comparator 1 intervention

Group B: Axolotl DualGraft + SOCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Efficacy of dhAM + SOC vs SOC

To determine the efficacy of dhAM plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers over 12 weeks.

Time frame

1-12 Weeks

Secondary outcomes

Time to closure for the target ulcer

To determine the proportion of ulcers that heal over 12 weeks for dhAM plus SOC versus SOC alone (Time to closure).

Time frame

1-12 weeks

Percent area reduction

To determine the percent area reduction (PAR) of the ulcer over the 12-week treatment period.

Time frame

1-12 weeks

Adverse events

To demonstrate a reduction in adverse events in subjects receiving dhAM plus SOC versus SOC alone.

Time frame

1-12 Weeks

Determine improvement in quality of life using Wound Quality of Life questionnaire

Quality of Life is assessed using the Wound Quality of Life (wQOL) checklist at TV1, TV3, TV7, TV11, and TV12. This assessment will be used to compare patients receiving dhAM + SOC vs SOC.

Time frame

1-12 weeks

Other outcomes

Proportion of ulcers that heal in patients 65 years and older

To determine the proportion of ulcers that heal in patients 65 years or older for dhAM plus SOC versus SOC alone.

Time frame

1-12 weeks

Determine the effect of chronic inhibitory bacterial load (CIBL) on wound closure

To determine the effect of chronic inhibitory bacterial load (CIBL) as assessed by fluorescence imaging on wound closure. Fluorescent imaging will be assessed at TV1, TV4, TV8, and TV12.

Time frame

1-12 weeks

Sponsors and contacts

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

Axolotl Biologix

Lead sponsor

SerenaGroup, Inc.

Collaborator

Source ClinicalTrials.gov

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