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

Conditions

• Diabetic Foot Ulcer (DFU)
• Lower Extremity

Eligibility Criteria

Sex

ALL

Age

21 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Graft Application — OTHER
  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
  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.

Study Details

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.

Key Dates

Start date

Jun 26, 2025

Status verified

Dec 2025

Primary completion

May 31, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Arm 1:
  Matrion
• Other: Arm 2
  Conventional Wound Management

Primary Outcome Measure

Wound Healing [ Time Frame: 12 Weeks ]

Locations (18)

Find similar trials in Tucson, AZ

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