A phase-IV, Open-Label, interventional, prospective, single arm Trial of Soreze Advance Gel for treatment of Pressure Ulcer Healing and Wound Care in Adult Subjects
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To compare percentage change in ulcer size, stage, length, width, and depth in patients
研究概览
简要总结
All patients meeting the inclusion criteria, with grade II and grade III ulcers, who sign the informed consent will be recruited for this single-arm, open-label study. Data on the primary endpoint, which is pressure ulcer size (stage, length, width, and depth), will be collected through clinician measurements and photographic documentation. Secondary endpoints will include infection status (including signs/symptoms of infection), amount and type of exudate, wound tissue color and type, and adverse events, all recorded at baseline. The wound surface area (length x width), exudate amount, and tissue type will be documented using the PUSH tool, and a baseline PUSH score will be calculated. Subjects will apply the investigational product twice daily, and information collected at each follow-up visit will include pressure ulcer size (length, width, depth via clinician measurement with photographic documentation), PUSH sub-scores and total score, time to complete wound closure, infection status, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects who are 18 years to 80 years of age (Both Years inclusive).
- •Patients who are willing and provide a signed, dated informed consent.
- •Patients who are available for follow-up.
- •The patient has one or more pressure ulcers (bedsores) (stage II or Stage III).
排除标准
- •The patient participating in another study, or has participated in another study in the last 28 days.
- •The patient is in an exclusion period determined by a previous study.
- •The patient refuses to sign the consent.
- •The patient is pregnant, parturient, or breastfeeding.
- •Patient under curative anticoagulation.
- •Patient is a woman of child-bearing potential and does not consent to or receive a screening urine pregnancy test prior to study enrolment.
- •Patient has any wound that at enrolment is scheduled for surgical closure within 14 days.
- •Patients having grade I & IV pressure ulcer.
- •Use of any immunosuppressant medications (for example, cyclosporine, methylprednisolone, prednisone, methotrexate, alefacept, or infliximab) within 30 days of screening.
结局指标
主要结局
To compare percentage change in ulcer size, stage, length, width, and depth in patients
时间窗: Visit-1, Visit-2, Visit-3, Visit-4, Visit-5, Visit-6, Visit-7
with at least one of stage II or Stage III pressure ulcer in subjects
时间窗: Visit-1, Visit-2, Visit-3, Visit-4, Visit-5, Visit-6, Visit-7
次要结局
- 1)To compare healing progress using the National Pressure Ulcer Advisory Panel’s(Pressure Ulcer Scale for Healing (PUSH) score and other indicators of wound healing)
研究者
Dr Rakesh verma
Jawahar Lal Nehru Medical College
