Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
BioStem Technologies
60 participants
Feb 14, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria14
- Patient has signed the informed consent form.
- Male or female patient at least 18 years of age or older, as of the date of the screening visit.
- Has a VLU between the knee and ankle (at or above the malleoli), with a surface area in the range of ≥ 2.0 cm2 and ≤ 20.0 cm2 when measured by the investigator staff at the screening visit using the eKare device post debridement.
- If the subject presents with \> 1, but ≤ 3 VLU on the same leg, the largest ulcer will be selected as the target ulcer.
- If the target ulcer is \< 1cm from another VLU, the ulcers should be traced as a single target ulcer provided at least one of the ulcers is at least 2.0 cm2 in area and the total surface area of the VLUs is ≤ 20.0 cm2.
- Target ulcer involves a full-thickness skin loss, but without exposure of tendon, muscle, or bone.
- Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months).
- Venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence.
- a. Availability of a complete report of a previous examination performed 12 months of screening will be acceptable, and this examination would not be required to be repeated.
- Arterial supply adequacy confirmed by any one of the following:
- Great toe pressure ≥ 50 mm/Hg
- Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.80 ≤ 1.10
- TcPO2 ≥ 40 mmHg from the foot
- Willing to follow all instructions given by the Investigator, return for all visits, and adhere to compression protocols while on the study.
Exclusion Criteria19
- A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
- Acute Deep Vein Thrombosis (DVT), defined as the first 10 days from onset of symptoms, or any DVT for which compression is considered by the Investigator to be contraindicated.
- Clinical evidence of ulcer bed infection, or infected hardware.
- Documented history of osteomyelitis at the target ulcer location within six (6) months preceding the screening visit.
- Refusal or inability to tolerate compression therapy.
- Pregnant women.
- Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
- Hemoglobin A1c (HbA1c) level is \> 12% (108 mmol/mol).
- Current therapy with systemic antibiotics.
- Current therapy with cytotoxic agents.
- Current therapy with chronic (\> 10 days) oral corticosteroids.
- Current therapy with TNFα inhibitors other than Trental® (pentoxifylline).
- Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
- Has malignancy or history of cancer in the preceding 5 years other than non-melanoma skin cancer.
- Currently on dialysis or planning to start dialysis.
- Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.
- Therapy of the target ulcer with other birth tissue products, autologous skin graft, Apligraf®, or Dermagraft® within 30 days preceding the screening visit.
- Therapy of the target ulcer with topical growth factors within thirty (30) days preceding the screening visit.
- Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.
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Interventions
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 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.
Locations(23)
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NCT06811909