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A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
Led by BioStem Technologies · Updated on 2026-01-23
60
Participants Needed
23
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with non-healing, non-infected venous leg ulcers (VLUs) that have adequate blood flow and confirmed venous reflux. The trial compares the use of a special human placental allograft called BioREtain Amnion Chorion (BR-AC) combined with standard care against standard care alone. The goal is to see if weekly applications of BR-AC lead to a higher rate of complete wound healing within 12 weeks. Participants will receive either standard care alone or standard care plus BR-AC. Standard care includes sharp debridement, cleansing with a gentle solution, applying a non-adherent wound contact layer with an alginate or foam pad to keep the wound moist and warm, and compression therapy using the UrgoK2 dual compression system. BR-AC is applied directly to the wound surface after debridement and trimmed to fit the wound. If wounds do not heal after 12 weeks on standard care alone, patients can crossover to receive BR-AC plus standard care for an additional 12 weeks. During the study, participants will have weekly visits to monitor wound healing, compliance with care, and compression use. Wound size will be measured using a specialized imaging device. Those who achieve complete healing will enter a four-week follow-up period with two visits to assess the durability of wound closure. The study aims to evaluate wound closure rates, time to healing, and the number of BR-AC applications needed.
CONDITIONS
Brief Title
Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has signed the informed consent form.
- Male or female patient at least 18 years of age or older.
- Has a venous leg ulcer between the knee and ankle with a surface area between 2.0 cm² and 20.0 cm².
- If there are multiple ulcers on the same leg, the largest ulcer will be selected as the target ulcer.
- If ulcers are less than 1 cm apart, they will be treated as a single ulcer if total area is 20.0 cm² or less.
- Target ulcer involves full-thickness skin loss without exposure of tendon, muscle, or bone.
- Target ulcer duration is between 4 weeks and 52 weeks.
- Venous insufficiency confirmed by duplex Doppler ultrasound.
- Adequate arterial blood supply confirmed by one of: great toe pressure ≥ 50 mm/Hg, ankle brachial index between 0.80 and 1.10, or TcPO2 ≥ 40 mmHg.
- Willingness to follow study instructions, attend all visits, and adhere to compression protocols.
You will not qualify if you...
- Ulcers of non-venous cause such as sickle cell anemia or other specified conditions.
- Acute deep vein thrombosis within 10 days of symptoms or contraindication to compression.
- Signs of infection in the ulcer or infected hardware.
- History of osteomyelitis at the ulcer site within 6 months.
- Inability or refusal to tolerate compression therapy.
- Pregnant women.
- Women of childbearing potential unwilling to use effective birth control.
- Hemoglobin A1c level greater than 12%.
- Current use of systemic antibiotics, cytotoxic agents, chronic oral corticosteroids, or certain TNFα inhibitors.
- Positive test for HIV or AIDS.
- History of cancer within 5 years except non-melanoma skin cancer.
- On or planning to start dialysis.
- Participation in another clinical trial within 30 days.
- Recent treatment of the ulcer with other birth tissue products, skin grafts, or topical growth factors.
- Previous use of specific wound products on the target ulcer.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants undergo a two-week run-in period with standardized care (compression therapy) to assess wound healing potential.
Weekly visits for 2 weeks
Duration - 12 weeks
Participants receive either standard care alone or standard care plus BR-AC to treat their venous leg ulcers.
Weekly visits for up to 12 weeks
Duration - Up to 12 weeks
Participants who did not achieve complete wound closure during the initial treatment phase and were in the standard care group may receive BR-AC plus standard care for an additional 12 weeks.
Weekly visits for up to 12 weeks
Duration - 4 weeks
Participants who achieve complete wound closure enter a follow-up phase to monitor the durability and longevity of the closed wound.
2 visits at two-week intervals
Trial Site Locations
Total: 23 locations
1
Site 17
Guntersville, Alabama, United States, 35976
Actively Recruiting
2
Site 2b
Castro Valley, California, United States, 94546
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3
Site 19b
Glendale, California, United States, 91204
Actively Recruiting
4
Site 36
Oxnard, California, United States, 93030
Actively Recruiting
5
Site 37
Oxnard, California, United States, 93036
Actively Recruiting
6
Site 19
Palmdale, California, United States, 93551
Actively Recruiting
7
Site 02
San Francisco, California, United States, 94115
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8
Site 2a
San Francisco, California, United States, 94117
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9
Site 04
Sylmar, California, United States, 91342
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10
Site 30
Torrance, California, United States, 90502
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11
Site 01
Vista, California, United States, 92081
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12
Site 34
Aventura, Florida, United States, 33180
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13
Site 27
Coral Gables, Florida, United States, 33134
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14
Site 20
Deerfield Beach, Florida, United States, 33442
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15
Site 33
Fort Walton Beach, Florida, United States, 32547
Withdrawn
16
Site 35
Miami, Florida, United States, 33126
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17
Site 31
Miami, Florida, United States, 33189
Terminated
18
Site 06
O'Fallon, Illinois, United States, 62269
Actively Recruiting
19
Site 18
Boston, Massachusetts, United States, 02118
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20
Site 32
St Louis, Missouri, United States, 63128
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21
Site 16
Lake Success, New York, United States, 11042
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22
Site 38
Corpus Christi, Texas, United States, 78414
Actively Recruiting
23
Site 03
Fort Worth, Texas, United States, 76104
Actively Recruiting
Research Team
N
Nick McCoy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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