Набор по приглашению NCT07414368

Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate for Acute and Chronic Wounds

— Наблюдательное Chronic Ulcers Diabetic Foot Ulcers (DFU) DFU Ulcer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Corplex P is used to cover, protect, and provide a moist wound environment.
Кому может быть актуально: Состояния в реестре: Chronic Ulcers, Diabetic Foot Ulcers (DFU), DFU, Ulcer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Retrospective, Single-center Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate Used for Treatment in Acute and Chronic Wounds

Обзор

The purpose of this observational case series is to assess the use of Corplex P as a resorbable particulate device used to cover, protect, and provide a moist wound environment when added to the standard of care treatment of hard-to-heal wounds.

Подробное описание

This is a retrospective, single-center observational case series to assess real-world outcomes of StimLabs dehydrated human umbilical cord particulate used in the management of hard-to-heal wounds, including acute and chronic ulcers. This case series will include real-world data from up to 10 subjects at one participating site. The Corplex P product has been utilized in a variety of patients attending wound clinics for management of partial and full-thickness wounds, pressure ulcers, venous leg ulcers (VLU), diabetic foot ulcers (DFUs), chronic vascular ulcers, and surgical wounds. The device is intended to cover, protect, and provide a moist wound environment. Medical records will be reviewed for subjects who received the Corplex P product, and data will be collected from baseline, first presentation, treatment, and follow up data. Data summaries will review wound closure, percent are reduction in wound size over treatment time, number of device applications required during treatment, time to wound closure, and adverse events.

Вмешательства

Устройство Corplex P is used to cover, protect, and provide a moist wound environment
Corplex P is derived from human birth tissue and used in wound management to cover, protect, and provide a moist wound environment.

Первичные конечные точки

The proportion of target ulcers achieving complete wound closure during the observational period [Срок оценки: 1-12 weeks]

Вторичные конечные точки (3)

Percent area reduction [Срок оценки: 1-12 weeks]
Time to closure for the target ulcer [Срок оценки: 1-12 weeks]
Adverse Events [Срок оценки: 1-12 weeks]

Критерии участия

Критерии включения

All consecutive subjects that received a Corplex P device application during wound management in the following retrospective cohort between February 2024 and November 2025.