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New treatment option for Non-infected Venous Leg Ulcer
Official title Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
ClinicalTrials.gov ID: NCT06811909
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
You likely can't join if
- A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or...
- 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...
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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.
What rules you out
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guntersville, Alabama, United States
- Castro Valley, California, United States
- Glendale, California, United States
- Oxnard, California, United States
- Palmdale, California, United States
- San Francisco, California, United States
- Sylmar, California, United States
- Torrance, California, United States
- Vista, California, United States
- Aventura, Florida, United States
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Fort Walton Beach, Florida, United States
- Miami, Florida, United States
- O'Fallon, Illinois, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Lake Success, New York, United States
- Corpus Christi, Texas, United States
- Fort Worth, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guntersville, Alabama, United States; Castro Valley, California, United States; Glendale, California, United States; Oxnard, California, United States; Palmdale, California, United States; San Francisco, California, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.