Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management

Conditions

• Diabetic Foot Ulcer

Eligibility Criteria

Sex

ALL

Age

50 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Orion TM Amniotic Membrane Allograft — DEVICE
  The intervention is a sterile allograft made from dehydrated extracellular matrix, designed to promote wound healing by providing a reliable and protective wound covering. Amniotic membranes are hypothesized to promote healing in open wounds by serving as a scaffold to support native tissue ingrowth, encouraging angiogenesis, and limiting microbial spread.
• Standard of Care (SOC) — PROCEDURE
  Standard wound care entails surgical debridement as needed to remove all non-viable tissue, screening for infection and probing of the wound for bone, weekly application of a collagen alginate primary dressing, and off-loading using a removable diabetic offloading cam-walker or total contact cast.

Study Details

The goal of this clinical trial is to learn if use of Orion™, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot ulcers. The study aims to determine the incidence of complete wound closure at the end of 12 weeks of treatment. Researchers will compare the outcomes between a group of people treated with standard wound care and another group treated with standard wound care in addition to the amniotic membrane allograft to see if the amniotic membrane allograft improves wound healing. During the study, participants will visit their doctor weekly over a 12 week period, which is standard for diabetic foot ulcer treatment procedures, and fill out a questionnaire measuring quality of life.

Key Dates

Start date

Dec 30, 2025

Status verified

Jun 2026

Primary completion

Nov 30, 2026

Completion

Jul 31, 2027

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: Standard of Care (SOC)
  Standard of care DFU wound management
• Experimental: Amniotic Membrane plus Standard of Care
  Weekly application of Orion™ amniotic membrane allograft in addition to standard of care DFU wound management

Primary Outcome Measure

Incidence of Complete Wound Closure [ Time Frame: starting from randomization until last visit of the 12-week wound management period ]

Central Contacts

• Cyaandi Dove, DPM
  210-567-5135
  [email protected]
• Christopher Schultz, BS, CCRA, ACRP-PM
  719-400-7463
  [email protected]

Locations (8)

Find similar trials in Palm Springs, CA

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