CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations

Официальное название

A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Tri- Layer Amnion Graft or a Single Layer Amnion Graft to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs

Обзор

CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs

Подробное описание

A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs

Hybrid prospective platform 2 arm, comparative, randomized multicenter study with a CSM matched retrospective control group Interventional comparative study

* IP 1: BioLab Membrane Wrap Lite * IP2: BioLab Tri-Membrane Wrap

Standard of care: Debridement, maintenance of proper moisture balance, reduction in bacterial burden, offloading and multilayer compression.

Patients with nonhealing venous leg ulcerations or diabetic foot ulcers of at least 4-weeks duration that have failed to show 50% PAR with SOC therapies Patients receiving SOC therapies for hard-to-heal VLUs and/or DFUs

To gather prospective real-world evidence (RWE) in both diabetic foot ulcers and venous leg ulcers increasing the understanding of treatment performance in everyday clinical settings, capturing insights from a more diverse patient population than traditional clinical trials. This information is vital for evaluating the effectiveness of innovative wound care strategies in practical, real-life scenarios

To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting wound healing compared to standard of care alone in venous leg ulcers and diabetic foot ulcers across the continuum of care.

Вмешательства

• Другое IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap
  BioLab Membrane Wrap LiteTM is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. Membrane Wrap LiteTM is a single-layer human tissue allograft, containing solely the amnion layer of Amniotic Membrane \[Human Cellular and Tissue Based Product (HCT/P)\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271.
• Другое IP2: BioLab Tri-Membrane Wrap
  BioLab Tri-Membrane WrapTM is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. Tri-Membrane WrapTM is a triple-layered human tissue allograft, containing amnion-chorion-amnion layers \[Human Cellular and Tissue Based Product (HCT/P)\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271.

Первичные конечные точки

• Wound Closure [Срок оценки: 12 Weeks]

Вторичные конечные точки (1)

• Wound percent area reduction [Срок оценки: Weeks 4, 8, and 12]

Критерии участия

Критерии включения

• Male or female 18 years of age and older
• 2\. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of >4 weeks duration and visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks
• Subjects' wound size is minimum of 2 cm2 and maximum of 25cm2
• If the subject has more than one eligible wound the largest wound will be selected (the index wound)
• Subject is able and willing to follow the protocol requirements
• Subject has signed informed consent

Критерии исключения

• Inability to adhere to the study protocol or study visit schedule
• Pregnancy
• Child-bearing potential without appropriate contraception
• Lactation
• Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.
• Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment)
• The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
• Known contraindications to the use of amniotic tissue grafts
• The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• FOMAT Medical Research — Oxnard
• Solutions Medical Research — Coral Gables
• Nova Medical Services - Research Division LLC — Miami
• Indiana University Health Methodist Hospital — Indianapolis
• St. Louis Foot and Ankle, LLC — St Louis
• Jevlos Health, Inc — Syosset
• Hope Vascular and Podiatry — Houston

Идентификаторы

NCT: NCT07046767 · CAMP RWE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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