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Treatment of non-healing venous leg ulcers with a new allograft

A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

Not applicable Interventional BioStem Technologies · NCT06811909

This study is testing if adding a new treatment using human placental tissue can help people with stubborn venous leg ulcers heal better when combined with regular care.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years and up
SexAll
SponsorBioStem Technologies Industry-sponsored
Locations23 sites (Guntersville, Alabama and 22 other locations)
Trial IDNCT06811909 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of the human placental allograft BioREtain® Amnion Chorion (BR-AC) in conjunction with standard care for patients suffering from non-healing venous leg ulcers (VLUs). Participants will be randomized to receive either standard care alone or standard care plus BR-AC, with the goal of achieving complete wound healing within 12 weeks. The study includes a crossover design, allowing those who do not heal with standard care to switch to BR-AC treatment for an additional 12 weeks. The trial will monitor wound healing progress through regular visits and advanced imaging technology.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with non-healing venous leg ulcers measuring between 2 cm² and 20 cm².

Not a fit: Patients with infected ulcers or those whose wounds are likely to heal with standard compression therapy alone may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients with chronic venous leg ulcers.

How similar studies have performed: Previous studies have shown promising results with similar allograft treatments for chronic wounds, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Guntersville, Alabama and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-infected Venous Leg UlcerVenous Leg UlcerVenous InsufficiencyVenous StasisVenous Reflux
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.