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L'essai clinique NCT06930768 pour Ulcère veineux de la jambe est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Evaluating the Efficacy of NeoThelium FT in the Treatment of Venous Leg Ulcers

Pas encore en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT06930768 est un essai interventionnel pour Ulcère veineux de la jambe. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 décembre 2025, avec un objectif de 132 participants. Dirigé par NuScience Medical Biologics, LLC, l'essai devrait être terminé d'ici le 1 octobre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 19 novembre 2025.
Résumé succinct
This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.
Description détaillée
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will be randomly assigned to one of two groups: either standard of care alone, or standard of care plus NeoThelium FT. As this is a post-marketing study, it will gather information about how effective the treatment is in treating venous leg ulcers. All subjects will complete two week screening phase prior to being randomized into a treatment arm. Treatment arms will consist of NeoThelium FT in conjunction with standard of care, vs. standard of care alone. The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 16 weeks. Secondary endpoints consist of wound area reduction rates, time to closure, follow-up closure, and pain assessment.
Titre officiel

Evaluation of the Efficacy of NeoThelium FT in the Healing of Venous Leg Ulcers: A Randomized Controlled Multicenter Trial

Conditions
Ulcère veineux de la jambe
Autres identifiants de l'essai
  • VELOCITY
Numéro NCT
NCT06930768
Date de début (réel)
2025-12-01
Dernière mise à jour publiée
2025-11-19
Date de fin (estimée)
2026-10-01
Inscription (estimée)
132
Type d'essai
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
Chronic wounds
Wound Medicine
Cellular, Acellular, Matrix-like Product (CAMP)
Cellular and/or Tissue Product (CTP)
Dehydrated Complete Human Placental Membrane (dCHPM)
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Comparateur actifNo Intervention: Standard of Care
Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading
Standard de soins
Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading
ExpérimentalIntervention: NeoThelium FT & Standard of Care
Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading
Neothelium FT
NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Complete Wound Closure
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure.
1-12 weeks
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Percentage Wound Area Change
The percentage change in wound area from TV-1 to TV-13 will be measured weekly using digital photographic planimetry and physical examination.
1-12 weeks
Time to Closure
Average number of grafts and/or weeks used to achieve wound closure
1-12 weeks
Follow-Up Closure
Number of wounds remaining closed during the 2-week follow-up
2 weeks
Pain Assessment
Change in pain associated with the target ulcer will be assessed using the Numeric Pain Rating Scale at designated time points
Day 0, Day 14, Day 35, Day 56, Day 84
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  1. Male or Female, 18 years of age or older
  2. Subject has a medical diagnosis of Venous Insufficiency with an open wound to the lower extremity
  3. Subject has a Venous Leg Ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
  4. Subject has a Venous Leg Ulcer with a historical wound measurement showing less than 50% healing in 30 days prior to randomization
  5. Subject has a Venous Leg Ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization
  6. Subject has a Venous Leg Ulcer Wagner 1, 2, and 3 without infection or clinically visible exposed bone
  7. Index ulcer is a minimum of 1cm2 and a maximum of 40cm2 at first treatment visit
  8. Venous Leg Ulcer is being treated with compression therapy for 14 days prior to randomization
  9. Adequate circulation of ulcer demonstrated by an ABI of >0.7 and <1.3, or TBI of >0.6 within 30 days prior to randomization
  10. Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.
  11. Index ulcer is free of necrotic debris prior to NeoThelium FT application
  12. Female subjects of childbearing potential having a negative pregnancy test prior to randomization
  13. Subject is able and willing to follow the protocol requirements
  14. Subject had signed informed consent
  15. If 2 or more ulcers are present, the ulcers must be separated by at least 1 cm

  1. Subject has a known life expectancy of <1 year
  2. Subject is unable to comply with protocol treatment
  3. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing
  4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
  5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
  6. Known contraindications to tissue-engineered allograft
  7. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and/or healing
  8. Wound reduces in area by ≥25% after 14 days of SOC prior to randomization
  9. Subject is pregnant or breastfeeding
  10. Subject with history of immunosuppressant treatment (systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for >2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study
  11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization
  12. Venous Leg Ulcer with active infection
  13. Wound depth with visible exposed bone
  14. HBOT within 14 days prior to randomization
  15. Revascularization surgery on the index ulcer leg within 30 days of screening phase
  16. Index ulcer suspicious of neoplasm in the opinion of the principal investigator
NuScience Medical Biologics, LLC logoNuScience Medical Biologics, LLC
SygNola, LLC logoSygNola, LLC
Contact central de l'essai
Contact: Angelina Ferguson, DNP, (985) 629-4013, [email protected]
Contact: Sarah Moore, MBE, (985) 629-4013, [email protected]
Aucune donnée sur les lieux ou centres d'investigation disponible