Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

Conditions

• Non-infected Venous Leg Ulcer
• Venous Insufficiency
• Venous Leg Ulcer
• Venous Reflux
• Venous Stasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BR-AC — OTHER
  BR-AC is an amnion layer, intermediate layer, and chorion layer placental membrane processed together with no separation of the layers. BR-AC is manufactured by BioStem Technologies, Inc. and is processed by the bioREtain method, which, briefly includes initial disinfection, processing with isotonic solutions, dehydration at 37-40°C, and electron beam sterilization.
• Standard Care — OTHER
  Standard Care is defined as: * Sharp debridement, * Wound cleansing with a neutral, non-irritating and non-toxic solution, * Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and * The UrgoK2™ dual compression system providing around 40 mmHg.

Study Details

This study examines a patient population with a non-healing, non-infected venous leg ulcer (VLU) having adequate arterial perfusion with confirmed venous reflux. It is hypothesized that weekly applications of the human placental allograft BioREtain® Amnion Chorion (BR-AC) applied to a non-healing VLU will result in a higher proportion of wounds showing complete healing within 12 weeks of initiating therapy, compared to standard care alone. This study has a crossover period, where subjects on standard care alone who do not achieve complete healing within 12 weeks of initiating therapy will be allowed to crossover to receive BR-AC over 12 additional weeks, to evaluate if their wound can achieve complete healing.

Key Dates

Start date

Feb 14, 2025

Status verified

Jan 2026

Primary completion

Aug 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: BR-AC plus Standard Care
  All subjects in the treatment group will receive sponsor-approved standard of care. Standard of care is defined as: * Sharp debridement, * Wound cleansing with a neutral, non-irritating and non-toxic solution, * Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and * The UrgoK2™ dual compression system providing around 40 mmHg. Using an appropriate size to cover the entire wound area, BR-AC should be applied directly to the wound surface following sharp debridement. It is recommended that the product be trimmed to fit the area of the wound with sterile scissors before application.
• Active Comparator: Standard Care
  All subjects in the control group will receive sponsor-approved standard of care. Standard of care is defined as: * Sharp debridement, * Wound cleansing with a neutral, non-irritating and non-toxic solution, * Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and * The UrgoK2™ dual compression system providing around 40 mmHg.

Primary Outcome Measure

To determine whether non-ischemic, non-infected VLUs treated with standard care plus BR-AC results in a higher probability of achieving complete wound closure compared to standard care alone. [ Time Frame: over the 12-week treatment period ]

Central Contacts

• Nick McCoy
  2144571996
  [email protected]

Locations (23)

Find similar trials in Guntersville, AL

Related Studies

• MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
  PHASE2 · Recruiting · Merakris Therapeutics · Tucson, Arizona
• Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
  Recruiting · Medaxis, LLC · Bradenton, Florida
• The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
  Recruiting · W.L.Gore & Associates · Stanford, California
• A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
  Recruiting · Molnlycke Health Care AB · Castro Valley, California