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

Recruiting now · Not applicable

Conditions studied: Non-infected Venous Leg Ulcer, Venous Leg Ulcer, Venous Insufficiency, Venous Stasis, Venous Reflux

In brief

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 facts

Study ID: NCT06811909
Run by: BioStem Technologies
People needed: 60
Starts: 2025-02-14
Expected to finish: 2026-10-01
Last updated by the study team: 2026-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Site 03 — Fort Worth, Texas, United States (enrolling)
Site 2b — Castro Valley, California, United States (enrolling)
Site 19b — Glendale, California, United States (enrolling)
Site 36 — Oxnard, California, United States (enrolling)
Site 37 — Oxnard, California, United States (enrolling)
Site 19 — Palmdale, California, United States (enrolling)
Site 02 — San Francisco, California, United States (enrolling)
Site 2a — San Francisco, California, United States (enrolling)
Site 04 — Sylmar, California, United States (enrolling)
Site 30 — Torrance, California, United States (enrolling)
Site 01 — Vista, California, United States (enrolling)
Site 34 — Aventura, Florida, United States (enrolling)
Site 27 — Coral Gables, Florida, United States (enrolling)
Site 20 — Deerfield Beach, Florida, United States (enrolling)
Site 38 — Corpus Christi, Texas, United States (enrolling)
Site 17 — Guntersville, Alabama, United States (enrolling)
Site 35 — Miami, Florida, United States (enrolling)
Site 06 — O'Fallon, Illinois, United States (enrolling)
Site 18 — Boston, Massachusetts, United States (enrolling)
Site 32 — St Louis, Missouri, United States (enrolling)
Site 16 — Lake Success, New York, United States (enrolling)
Site 33 — Fort Walton Beach, Florida, United States
Site 31 — Miami, Florida, United States

Full record on ClinicalTrials.gov

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