An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care Treatments From a Variety of Treatment Settings
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Siddhey LLC
- 入组人数
- 5,000
- 试验地点
- 21
- 主要终点
- Percentage wound area reduction over time while receiving study product using wound imaging device software or measurement scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
- •Affected extremity requiring hyperbaric oxygen during the study or within 2 weeks of Visit
- •Known HbA1c >12%.
- •Subjects who are pregnant or breastfeeding.
研究组 & 干预措施
Wound Treatment
Interventions are at the discretion of treating clinicians and include standard and advanced wound therapies.
干预措施: Various types of wound care treatments (Combination Product)
结局指标
主要结局
Percentage wound area reduction over time while receiving study product using wound imaging device software or measurement scale
时间窗: Up to 12 weeks
Analysis will be based on product type (e.g., hydrocolloid, amniotic-based, etc.) and wound type (e.g., DFU, VLU, etc.)
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)
时间窗: Up to 12 weeks
Note: Analysis will be based on product type (e.g., hydrocolloid, amniotic-based, etc.) and wound type (e.g., DFU, VLU, etc.)
次要结局
- Proportion of wounds achieving complete closure over time(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(Up to 12 weeks)
- Time to achieve complete wound closure while receiving study product(Up to 12 weeks)