Health TrialsbyHealthPanel

Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.

ConditionsDiabetic Foot Ulcer (DFU)Amnio-Maxx
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal Biologics

About this trial

This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The potential subject is 18 years of age or older. At least 50% of the enrolled population must be > 65 years of age.

The potential subject has a history of Type I or Type II Diabetes Mellitus requiring treatment by a physician with either oral medications and/or insulin replacement therapy.

Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening visit on any aspect of the foot, provided it is at or below the aspect of the medial malleolus. [NOTE: If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study. Index ulcer must be more than 5 cm distant apart.]

A diabetic foot ulcer present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.

Disqualifiers

The Subject has a known life expectancy of < 1 year.

Index ulcer has been present for >1 year.

Patient does not have adequate 2-week historical data demonstrating < 20% area reduction.

Subject is unable to comply with offloading device.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amnio-Maxx® Dual Layer Amnion Patch

    Biological/Vaccine

    Application of Amnio-Maxx® Dual Layer Amnion Patch

  • Standard of Care (Investigator Choice)

    Other intervention

    Cleansing, debridement, wound documentation, off-loading

Treatment groups

248 Participants
are divided into 2 treatment groups
Group A: Standard of CareExperimental treatment 1 intervention
Group B: Amnio-Maxx® Dual Layer Amnion PatchExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Complete Ulcer Closure

Time frame
12 weeks
2

Expected percentage area reduction (PAR)

Time frame
12-weeks

Secondary outcomes

1

Average percentage change from baseline in pain level related to the ulcer estimated from observed data using Numeric Pain Rating Scale (NPRS) and a Bayesian mixed effect model.

Time frame
12 weeks
2

Adverse events (AE)

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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

Royal Biologics

Lead sponsor

Source ClinicalTrials.gov
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