Clinical Registry Collecting Real World Evidence on Wound Care Treatments

Официальное название

An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care Treatments From a Variety of Treatment Settings

Обзор

The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.

Подробное описание

This clinical registry is an observational study to collect prospective and retrospective data on subjects' health, wounds and wound care procedures from medical centers, including skilled nursing facilities, hospitals, outpatient clinics, Home Health and any other medical environment where wounds are treated.

The registry will enroll data of up to 5000 subjects in up to 100 wound care locations. The dataset includes all wound and ulcer types. Investigators will follow Institutional standards for routine wound care practices. The study products supplied through this study will be applied to the wounds as an adjunct to the standard of care treatment.

Вмешательства

• Комбинированный продукт Various types of wound care treatments
  Treatments including, but not limited to: * Hydrocolloid * Foam * Alginate * Hydrogel * Collagen * Antimicrobial (e.g., silver, iodine) * Film * Composite * Negative Pressure (NPWT) * Amniotic-based

Первичные конечные точки

• Percentage wound area reduction over time while receiving study product using wound imaging device software or measurement scale [Срок оценки: Up to 12 weeks]
• Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events (AEs) related to wounds, and device-related adverse events (DRAEs) [Срок оценки: Up to 12 weeks]

Вторичные конечные точки (3)

• Proportion of wounds achieving complete closure over time [Срок оценки: Up to 12 weeks]
• Time to achieve complete wound closure while receiving study product [Срок оценки: Up to 12 weeks]
• Assessment of patient reported wound-related pain using a numeric pain rating scale of 0 (no pain) to 10 (worst possible pain) during study product application [Срок оценки: Up to 12 weeks]

Критерии участия

Критерии включения

• Subject is male or female ≥18 years of age.
• Subject has an ulcer (Diabetic foot ulcer, Venous stasis ulcer, etc.), injury (trauma, post -surgical, MOHS treatment), Burns injury, and/or other acute/chronic wounds.
• Subject has clinical documentation of no visible wound improvement in the wound after 4 weeks of standard of care therapy.
• Study wound is a minimum of 1 cm2 at Visit 1.
• The subject is able and willing to follow the protocol requirements.
• The subject has signed the informed consent form.
• Subject has adequate circulation to the affected extremity. Note: This will be confirmed by vascular perfusion assessment performed prior to enrollment, if clinically indicated per Institutional standard of care.

Критерии исключения

• Subject has a known life expectancy < 1 year.
• Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver, or pulmonary disease, lupus, palliative care or sickle cell anemia.
• Subject currently being treated for an active malignant disease or subjects with a history of malignancy within the wound.
• Known contraindications to advance therapy tissues or products.
• Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10 mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the wound surface within one month prior to Visit 1.
• Affected extremity requiring hyperbaric oxygen during the study or within 2 weeks of Visit 1.
• Known HbA1c >12%.
• Subjects who are pregnant or breastfeeding.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 12 центров

• Pulse Cardiovascular Institute — Scottsdale
• Metro Foot & Ankle — Tempe
• Pima Foot and Ankle Surgery LLC — Tucson
• Signature Health Medical Group — Riverside
• The Schottenstein Center — Hallandale
• PerfectFeetCare Podiatry Centers — Hialeah
• The Schottenstein Center — Miami
• PerfectFeetCare Podiatry Centers — Miami
• … и ещё 4 центра

Идентификаторы

NCT: NCT06328010 · SIDDXAC02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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