2023-504348-32-01招募中2 期
Acetic Acid in Cutaneous Ulcers. Randomized Controlled Trial.
Consorci Sanitari De L'Alt Penedes I Garraf1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2023年10月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in ulcer area (percentage of baseline area) 8 weeks after start of treatment
研究概览
简要总结
To study the efficacy of topical treatment with acetic acid versus control to improve healing of skin ulcers with biofilm, in terms of change in ulcer area from baseline (percentage), at 8 weeks of treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age.
- •Continuous care (hospital or outpatient) in one of the study center units.
- •Presence of skin ulcer with biofilm, with an area of less than 120 cm2, and in any location (except the facial region).
- •Anticipation of treatment and follow-up of the ulcer (at least 8 weeks) at the study center.
- •Possibility of collaborating in the necessary evaluations.
- •Informed consent for study inclusion, own or by the legal representative of the participant.
排除标准
- •Participants diagnosed with any of the following pathologies: a) Ulcers with exposed bone tissue. b) Ulcers of neoplastic origin c) Ulcers older than 18 months
- •Participation in another clinical trial that involves an experimental intervention during the period of this trial and/or establishes a periodicity of visits that is incompatible with this trial.
结局指标
主要结局
Change in ulcer area (percentage of baseline area) 8 weeks after start of treatment
Change in ulcer area (percentage of baseline area) 8 weeks after start of treatment
次要结局
- Percentage of participants with ulcer healing 4 weeks after starting treatment
- Percentage of participants with ulcer healing at 12 weeks from the start of treatment.
- Time (days) to ulcer healing from start of treatment.
- Time (days) until hospital discharge from the CSAPG, according to the clinical history record.
- Changes in the wound bed at 8 weeks according to section 6 of the RESVECH 2.0 scale
- Number of adverse reactions associated with the treatment, collected from the clinical history.
- Healthcare expense associated with each branch of the study, using the center's billing data associated with the use of resources by the insured
研究者
Àrea de Recerca
Scientific
Consorci Sanitari De L'Alt Penedes I Garraf
研究点 (1)
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