Health TrialsbyHealthPanel

Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers

ConditionsDiabetic Foot Ulcer (DFU)Lower Extremity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorLifeNet Health

About this trial

This study will evaluate Matrion™ (LifeNet Health, Inc., Virginia Beach, VA), a placental membrane product, as a treatment for diabetic foot ulcers compared to conventional wound care. Matrion is derived from donated human birth tissue and includes both the amniotic and chorionic layers, along with the trophoblast layer. It is minimally processed using a proprietary decellularization method and terminally sterilized to ensure the membrane is acellular and sterile, making it suitable for surgical applications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be male or female and aged between 21 and 80 years at the time of informed consent

Have a diagnosis of Type I or Type II diabetes as defined by the American Diabetes Association and have been on a stable anti-diabetic treatment regimen for at least 30 days before the baseline visit.

Have full-thickness wound of the lower extremity, below the ankle

Have a single target ulcer

Disqualifiers

Be pregnant or lactating

Subjects with a target wound <30 days old at Screening whose wound area has decreased in size ≥50% between the Screening and Baseline Visits (assessed at Baseline/Visit 2)

Have a circulating hemoglobin A1c exceeding 12% within 90 days of the Screening Visit (assessed at Screening/Visit 1 for subjects with labs collected <30 days of screening; assessed at Baseline/Visit 2 for subjects with labs collected at screening)

Have a serum creatinine concentration of 3.0 mg/dL or greater within 30 days prior to screening (assessed at Screening/Visit 1 for subjects with labs collected <30 days of screening; assessed at Baseline/Visit 2 for subjects with labs collected at screening)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Graft Application

    Other intervention

    Place the graft on the debrided DFU and secure. Follow with conventional care wound management (dressings and off-loading). Product may be applied weekly.

  • Wound Dressing Material

    Other intervention

    The wound will be debrided and undergo a moist-wound therapy and will be covered with a gauze that is appropriate for the type of wound (moist or dry). Dressings will cover each wound wound for at least 5 days, but no more than 9 days, (7 days +/- 2 days) until the next study visit. Off-loading of the wound is required.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Arm 1:Other 1 intervention
Group B: Arm 2Other 1 intervention

Trial outcomes

Primary outcomes

1

Wound Healing

Proportion of diabetic foot ulcers that have achieved complete wound closure

Time frame
12 Weeks

Secondary outcomes

1

Speed of Wound Closure

Time to wound closure measured from the baseline visit to the termination visit

Time frame
12 weeks
2

Change in Wound Area

Change in wound area over time

Time frame
12 weeks
3

Assessment of Wound Closure Rates in Study Participants

Number of subjects with a healed wound

Time frame
12 weeks
4

Infection

Rate of wound infection

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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

LifeNet Health

Lead sponsor

Source ClinicalTrials.gov
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