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Niet-genezende veneuze beenzweren behandeld met standaardzorg met of zonder BR-AC

2 november 2026 bijgewerkt door: BioStem Technologies

Een prospectieve, multicenter, gerandomiseerde, gecontroleerde studie van niet-genezende veneuze beenzweren behandeld met standaardzorg met of zonder 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

71

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Alabama
      • Guntersville, Alabama, Verenigde Staten, 35976
        • Site 17
    • California
      • Castro Valley, California, Verenigde Staten, 94546
        • Site 2b
      • Glendale, California, Verenigde Staten, 91204
        • Site 19b
      • Oxnard, California, Verenigde Staten, 93030
        • Site 36
      • Oxnard, California, Verenigde Staten, 93036
        • Site 37
      • Palmdale, California, Verenigde Staten, 93551
        • Site 19
      • San Francisco, California, Verenigde Staten, 94115
        • Site 02
      • San Francisco, California, Verenigde Staten, 94117
        • Site 2a
      • Sylmar, California, Verenigde Staten, 91342
        • Site 04
      • Torrance, California, Verenigde Staten, 90502
        • Site 30
      • Vista, California, Verenigde Staten, 92081
        • Site 01
    • Florida
      • Aventura, Florida, Verenigde Staten, 33180
        • Site 34
      • Coral Gables, Florida, Verenigde Staten, 33134
        • Site 27
      • Deerfield Beach, Florida, Verenigde Staten, 33442
        • Site 20
      • Miami, Florida, Verenigde Staten, 33126
        • Site 35
      • Miami, Florida, Verenigde Staten, 33189
        • Site 31
    • Illinois
      • O'Fallon, Illinois, Verenigde Staten, 62269
        • Site 06
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02118
        • Site 18
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63128
        • Site 32
    • New York
      • Lake Success, New York, Verenigde Staten, 11042
        • Site 16
    • Texas
      • Corpus Christi, Texas, Verenigde Staten, 78414
        • Site 38
      • Fort Worth, Texas, Verenigde Staten, 76104
        • Site 03

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: BR-AC plus Standard Care

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.
Ander: BR-AC

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.
Actieve vergelijker: Standard Care

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.
Ander: Standard Care

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: over the 12-week treatment period

Percentage of subjects with complete wound closure over the 12-week treatment period, defined as 100% reepithelialization
over the 12-week treatment period

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To compare differences between treatment groups in proportions of wounds with complete wound closure, based on time in days to closure
Tijdsspanne: at 12 weeks

Percent change from baseline in wound surface area (cm2) at 12-weeks post-randomization
at 12 weeks
To compare differences between treatment groups in percent change in wound area (cm2)
Tijdsspanne: at 12 weeks

Percent change from baseline in wound surface area (cm2) at 12-weeks post-randomization
at 12 weeks
To determine the total number of applications of BR-AC needed to achieve complete wound closure
Tijdsspanne: at 12 weeks

Percent change from baseline in wound volume (cm3) at 12-weeks post-randomization
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
Tijdsspanne: over an additional 12 weeks

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
over an additional 12 weeks

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants that acquire clinical signs and symptoms of infections post-randomization
Tijdsspanne: over 12-weeks post-randomization

Differences in clinical signs and symptoms of infection from Visit 2 through end of study between the treatment groups
over 12-weeks post-randomization
Proportion of subjects experiencing adverse events, by treatment group
Tijdsspanne: over the 17-week study period

Spontaneously reported and elicited adverse events, coded in MedDRA
over the 17-week study period

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

BioStem Technologies

Onderzoekers

  • Studie directeur: Bert Slade, MD, Independent

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 februari 2025

Primaire voltooiing (Werkelijk)

14 augustus 2026

Studie voltooiing (Werkelijk)

14 augustus 2026

Studieregistratiedata

Eerst ingediend

22 januari 2025

Eerst ingediend dat voldeed aan de QC-criteria

5 februari 2025

Eerst geplaatst (Werkelijk)

6 februari 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BR-AC-VLU-101

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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