Actively Recruiting
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
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Signed informed consent form.
- Male or female aged 18 years or older.
- Venous leg ulcer located between the knee and ankle (at or above the malleoli).
- Ulcer surface area between 2.0 cm² and 20.0 cm² measured after debridement.
- If multiple ulcers (up to 3) on the same leg, largest ulcer selected as target ulcer.
- If ulcers are less than 1 cm apart, they may be measured as a single target ulcer if total area is 20.0 cm² or less.
- Target ulcer involves full-thickness skin loss without exposure of tendon, muscle, or bone.
- Ulcer duration between 4 weeks and 52 weeks.
- Venous insufficiency confirmed by duplex Doppler ultrasound within 12 months.
- Adequate arterial blood supply confirmed by great toe pressure ≥ 50 mmHg, 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 therapy.
You will not qualify if you...
- Ulcer caused by non-venous conditions (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum).
- Acute Deep Vein Thrombosis within 10 days of symptoms or contraindicated compression.
- Evidence of ulcer bed infection or infected hardware.
- History of osteomyelitis at ulcer site within 6 months.
- Refusal or inability to tolerate compression therapy.
- Pregnant women or women unwilling to avoid pregnancy or use birth control.
- Hemoglobin A1c level greater than 12%.
- Current use of systemic antibiotics, cytotoxic agents, chronic oral corticosteroids, or TNFB1 inhibitors other than Trental�.
- Positive test for HIV or diagnosis of AIDS.
- Cancer or history of cancer within past 5 years except non-melanoma skin cancer.
- Currently on or planning dialysis.
- Participation in another device, drug, or biologic trial within 30 days.
- Recent treatment of ulcer with other birth tissue products, skin grafts, or topical growth factors within 30 days.
- Previous use of Vendaje�, Vendaje AC�, or AmnioWrap2� on the target ulcer.
AI-Screening
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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
Actively Recruiting
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
Actively Recruiting
8
Site 2a
San Francisco, California, United States, 94117
Actively Recruiting
9
Site 04
Sylmar, California, United States, 91342
Actively Recruiting
10
Site 30
Torrance, California, United States, 90502
Actively Recruiting
11
Site 01
Vista, California, United States, 92081
Actively Recruiting
12
Site 34
Aventura, Florida, United States, 33180
Actively Recruiting
13
Site 27
Coral Gables, Florida, United States, 33134
Actively Recruiting
14
Site 20
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
15
Site 33
Fort Walton Beach, Florida, United States, 32547
Withdrawn
16
Site 35
Miami, Florida, United States, 33126
Actively Recruiting
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
Actively Recruiting
20
Site 32
St Louis, Missouri, United States, 63128
Actively Recruiting
21
Site 16
Lake Success, New York, United States, 11042
Actively Recruiting
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
CONTACT
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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