Non-infected Venous Leg UlcerNCT06811909
Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
A study testing BR-AC in people with Non-infected Venous Leg Ulcer and Venous Leg Ulcer, run by BioStem Technologies at 22 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-infected Venous Leg Ulcer, Venous Leg Ulcer, Venous Insufficiency
- What is being tested?
- BR-AC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 22 sitesUnited States
- Study dates
- 14 Feb 2025to 14 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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.
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- Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months).
- Venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Site 34
Aventura, Florida, 33180
Site 18
Boston, Massachusetts, 02118
Site 2b
Castro Valley, California, 94546
Site 27
Coral Gables, Florida, 33134
Site 38
Corpus Christi, Texas, 78414
Site 20
Deerfield Beach, Florida, 33442
Site 03
Fort Worth, Texas, 76104
Site 19b
Glendale, California, 91204
Site 17
Guntersville, Alabama, 35976
Site 16
Lake Success, New York, 11042
Site 35
Miami, Florida, 33126
Site 31
Miami, Florida, 33189
Site 06
O'Fallon, Illinois, 62269
Site 36
Oxnard, California, 93030
Site 37
Oxnard, California, 93036
Site 19
Palmdale, California, 93551
Site 02
San Francisco, California, 94115
Site 2a
San Francisco, California, 94117
Site 32
St Louis, Missouri, 63128
Site 04
Sylmar, California, 91342
Site 30
Torrance, California, 90502
Site 01
Vista, California, 92081
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
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.
Read the detailed description
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BR-AC plus standard of care versus standard of care only in the treatment of venous leg ulcers. The eligibility criteria for this study will allow for enrollment of subjects with a VLU in the range of 2 cm^2 to 20 cm^2 in area. A lower size of 2 cm^2 was selected to exclude subjects who are likely to heal under compression therapy alone.
During the two-week run-in period, subjects who show a reduction in wound area predictive of achieving complete wound closure within 12 weeks under standardized care alone (i.e., compression therapy) will be excluded from the study. Eliminating these subjects will improve the estimated treatment effect. The criteria for duration, ≥ 4 weeks but ≤ 52 weeks, allows for the selection of those wounds that have demonstrated chronicity but may still have the potential to achieve wound closure.
The trial design will control potential variables that may affect the outcome between the treatment group and the control group by standardizing the requirements for evaluating venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence, debridement, and compression therapy. Weekly subject visits will help monitor compliance in wound care and compression therapy, as well as to document when wound closureis achieved. The study will implement the use of an electronic imaging and measurement device (eKare inSight®) using a standardized protocol to ensure the measuring of the wound surface area is accurate, highly reproducible, and minimally variable.
There will also be a crossover treatment phase for those patients that were relegated to SOC only. After their 12-week standard of care treatment phase and for only those subjects that did not achieve complete wound closure, will be allowed to crossover for an additional 12 weeks of treatment with the BR-AC product following the protocol and procedures set forth within this document.
A follow-up phase will commence for all subjects that achieve complete wound closure, which is designed to measure longevity and durability of the closed wound. This follow-up period will consist of a four-week follow-up with two visits at each two-week interval.
- Conditions
- Non-infected Venous Leg Ulcer, Venous Leg Ulcer, Venous Insufficiency, Venous Stasis, Venous Reflux
- Being tested
- BR-AC, Standard Care
- Medical subject headings
- Varicose Ulcer, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR-ACOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| BR-AC plus Standard Care | Experimental | All subjects in the treatment group will receive sponsor-approved standard of care. Standard of 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.
Using an appropriate size to cover the entire wound area, BR-AC should be applied directly to the wound surface following sharp debridement. It is recommended that the product be trimmed to fit the area of the wound with sterile scissors before application. Receives: Other: BR-AC |
| Standard Care | Active comparator | All subjects in the control group will receive sponsor-approved standard of care. Standard of 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. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether non-ischemic, non-infected VLUs treated with standard care plus BR-AC results in a higher probability of achieving complete wound closure compared to standard care alone.
Percentage of subjects with complete wound closure over the 12-week treatment period, defined as 100% reepithelialization
Measured: over the 12-week treatment period
Secondary outcomes (4)
To compare differences between treatment groups in proportions of wounds with complete wound closure, based on time in days to closure
Percent change from baseline in wound surface area (cm2) at 12-weeks post-randomization
Measured: at 12 weeks
To compare differences between treatment groups in percent change in wound area (cm2)
Percent change from baseline in wound surface area (cm2) at 12-weeks post-randomization
Measured: at 12 weeks
To determine the total number of applications of BR-AC needed to achieve complete wound closure
Percent change from baseline in wound volume (cm3) at 12-weeks post-randomization
Measured: at 12 weeks
To determine whether subjects that crossover and receive standard care plus BR-AC results in a higher probability of achieving complete wound closure over the 12 additional weeks versus standard care alone
Time in days from Visit 18 to initial observation of wound closure (defined as 100% reepithelialization of the wound without drainage) over an additional 12 weeks (Visits 19-30), where healing has been confirmed at two visits two weeks apart
Measured: over an additional 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start14 Feb 2025
- Primary completion14 Aug 2026
- Study completion14 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-infected Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioStem Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bert Slade, MD, Study director, Independent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811909
- Sponsor's protocol ID
- BR-AC-VLU-101
- Status last verified
- Nov 2026
- First submitted
- 22 Jan 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
- ClinicalTrials.gov ID
- NCT06811909
- Acronym / sponsor ID
- BR-AC-VLU-101
- Conditions
- Non-infected Venous Leg Ulcer, Venous Leg Ulcer, Venous Insufficiency, Venous Stasis, Venous Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- BioStem TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 14 Aug 2026 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BR-AC plus standard of care versus standard of care only in the treatment of venous leg ulcers. The eligibility criteria for this study will allow for enrollment of subjects with a VLU in the range of 2 cm^2 to 20 cm^2 in area. A lower size of 2 cm^2 was selected to exclude subjects who are likely to heal under compression therapy alone.
During the two-week run-in period, subjects who show a reduction in wound area predictive of achieving complete wound closure within 12 weeks under standardized care alone (i.e., compression therapy) will be excluded from the study. Eliminating these subjects will improve the estimated treatment effect. The criteria for duration, ≥ 4 weeks but ≤ 52 weeks, allows for the selection of those wounds that have demonstrated chronicity but may still have the potential to achieve wound closure.
The trial design will control potential variables that may affect the outcome between the treatment group and the control group by standardizing the requirements for evaluating venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence, debridement, and compression therapy. Weekly subject visits will help monitor compliance in wound care and compression therapy, as well as to document when wound closureis achieved. The study will implement the use of an electronic imaging and measurement device (eKare inSight®) using a standardized protocol to ensure the measuring of the wound surface area is accurate, highly reproducible, and minimally variable.
There will also be a crossover treatment phase for those patients that were relegated to SOC only. After their 12-week standard of care treatment phase and for only those subjects that did not achieve complete wound closure, will be allowed to crossover for an additional 12 weeks of treatment with the BR-AC product following the protocol and procedures set forth within this document.
A follow-up phase will commence for all subjects that achieve complete wound closure, which is designed to measure longevity and durability of the closed wound. This follow-up period will consist of a four-week follow-up with two visits at each two-week interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BR-AC plus Standard Care | Experimental | Other: BR-ACAll subjects in the treatment group will receive sponsor-approved standard of care. Standard of 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. Using an appropriate size to cover the entire wound area, BR-AC should be applied directly to the wound surface following sharp debridement. It is recommended that the product be trimmed to fit the area of the wound with sterile scissors before application. |
| Standard Care | Active comparator | Other: Standard CareAll subjects in the control group will receive sponsor-approved standard of care. Standard of 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- 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).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BR-ACBR-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. | Other | BR-AC plus Standard Care |
| Standard CareStandard 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. | Other | Standard Care |
Primary outcome
To determine whether non-ischemic, non-infected VLUs treated with standard care plus BR-AC results in a higher probability of achieving complete wound closure compared to standard care alone.
Time frame: over the 12-week treatment period
Percentage of subjects with complete wound closure over the 12-week treatment period, defined as 100% reepithelialization
4 secondary outcomes
To compare differences between treatment groups in proportions of wounds with complete wound closure, based on time in days to closure
Time frame: at 12 weeks
To compare differences between treatment groups in percent change in wound area (cm2)
Time frame: at 12 weeks
To determine the total number of applications of BR-AC needed to achieve complete wound closure
Time frame: at 12 weeks
To determine whether subjects that crossover and receive standard care plus BR-AC results in a higher probability of achieving complete wound closure over the 12 additional weeks versus standard care alone
Time frame: over an additional 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bert Slade, MD study director
Independent
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BR-AC in people with Non-infected Venous Leg Ulcer and Venous Leg Ulcer, run by BioStem Technologies at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether non-ischemic, non-infected VLUs treated with standard care plus BR-AC results in a higher probability of achieving complete wound closure compared to standard care alone. (time frame: over the 12-week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.