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Placental patch shows promise for stubborn leg wounds

NCT ID NCT06811909

Disease control Sponsor: BioStem Technologies Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 13, 2026 · Updated 4 times

Summary

This study tests whether a special placental membrane called BR-AC, applied weekly, can help heal non-healing venous leg ulcers faster than standard care alone. About 60 adults with a leg ulcer between the knee and ankle will be randomly assigned to get either standard care plus BR-AC or standard care only. The goal is to see if more wounds close completely within 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BR-AC (a processed human placental membrane)
What this could lead to
If it works, this could provide a new treatment option to help heal stubborn venous leg ulcers faster.
What could go wrong
This is a small early trial with only 60 participants, so results may not apply to everyone. The treatment may not heal ulcers better than standard care alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

71 people

The number who actually took part.

Started

Feb 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient has signed the informed consent form. 2. Male or female patient at least 18 years of age or older, as of the date of the screening visit. 3. 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. 1. If the subject presents with \> 1, but ≤ 3 VLU on the same leg, the largest ulcer will be selected as the target ulcer. 2. 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. 4. Target ulcer involves a full-thickness skin loss, but without exposure of tendon, muscle, or bone. 5. Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months). 6. 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. 7. Arterial supply adequacy confirmed by any one of the following: 1. Great toe pressure ≥ 50 mm/Hg 2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.80 ≤ 1.10 3. TcPO2 ≥ 40 mmHg from the foot 8. Willing to follow all instructions given by the Investigator, return for all visits, and adhere to compression protocols while on the study. Exclusion Criteria: 1. A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic). 2. 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. 3. Clinical evidence of ulcer bed infection, or infected hardware. 4. Documented history of osteomyelitis at the target ulcer location within six (6) months preceding the screening visit. 5. Refusal or inability to tolerate compression therapy. 6. Pregnant women. 7. Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control. 8. Hemoglobin A1c (HbA1c) level is \> 12% (108 mmol/mol). 9. Current therapy with systemic antibiotics. 10. Current therapy with cytotoxic agents. 11. Current therapy with chronic (\> 10 days) oral corticosteroids. 12. Current therapy with TNFα inhibitors other than Trental® (pentoxifylline). 13. Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS). 14. Has malignancy or history of cancer in the preceding 5 years other than non-melanoma skin cancer. 15. Currently on dialysis or planning to start dialysis. 16. Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening. 17. Therapy of the target ulcer with other birth tissue products, autologous skin graft, Apligraf®, or Dermagraft® within 30 days preceding the screening visit. 18. Therapy of the target ulcer with topical growth factors within thirty (30) days preceding the screening visit. 19. Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.

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Conditions

The condition(s) this trial relates to.

ulcer of lower limbs Varicose Ulcer venous insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-infected venous leg ulcer Venous insufficiency Venous leg ulcer Venous reflux Venous stasis

Contacts and locations

Locations

  • Site 01

    Vista, California, 92081, United States

  • Site 02

    San Francisco, California, 94115, United States

  • Site 03

    Fort Worth, Texas, 76104, United States

  • Site 04

    Sylmar, California, 91342, United States

  • Site 06

    O'Fallon, Illinois, 62269, United States

  • Site 16

    Lake Success, New York, 11042, United States

  • Site 17

    Guntersville, Alabama, 35976, United States

  • Site 18

    Boston, Massachusetts, 02118, United States

  • Site 19

    Palmdale, California, 93551, United States

  • Site 19b

    Glendale, California, 91204, United States

  • Site 20

    Deerfield Beach, Florida, 33442, United States

  • Site 27

    Coral Gables, Florida, 33134, United States

  • Site 2a

    San Francisco, California, 94117, United States

  • Site 2b

    Castro Valley, California, 94546, United States

  • Site 30

    Torrance, California, 90502, United States

  • Site 31

    Miami, Florida, 33189, United States

  • Site 32

    St Louis, Missouri, 63128, United States

  • Site 34

    Aventura, Florida, 33180, United States

  • Site 35

    Miami, Florida, 33126, United States

  • Site 36

    Oxnard, California, 93030, United States

  • Site 37

    Oxnard, California, 93036, United States

  • Site 38

    Corpus Christi, Texas, 78414, United States

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