2024-512612-22-00招募中3 期
A randomized double-blind clinical trial comparing Hypochlorous Acid and Polyhexamethylene biguanide in treating diabetic foot ulcers
Vaestra Goetalandsregionen, University Of Gothenburg13 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2024年11月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 202
- 试验地点
- 13
- 主要终点
- The primary endpoint variable is difference in the time from baseline (randomization) to healing for patients randomized to treatment with HOCl and PHMB evaluated over 24 weeks of treatment measured as hazard ratio.
研究概览
简要总结
The primary aim of this trial is to evaluate time to healing. This means to evaluate the efficiency of local antimicrobial agents to bring about complete healing of DFU, diabetic foot ulcer.
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
- 是
入选标准
- •Written and verbal informed consent given before trial-related activities
- •Diabetes type 1, type 2 or diabetes due to pancreatitis
- •Foot ulcer ≥ 10 days
- •Ulcer surface area ≥ 9 mm2
- •Age 18 years old or older
排除标准
- •Persons in need of intensive care or dialysis.
- •Debut of atrial fibrillation or heart failure (ejection fraction <40 %) during the last 4 weeks.
- •Treatment with corticosteroids of a dose corresponding to 50 mg Prednisolone or higher.
- •Severe wound infection according to the International Working Group of the Diabetic Foot comprising at least 2 of the following signs: body temperature>38°C or <36°C, heart rate >90 beats/minute, respiration rate >20/minute, LPK>12 x 10^9
- •Planned changed residence within the next 26 weeks requiring change of clinic for wound treatment during the follow-up time.
- •Age <18 years old.
- •If the toe or foot where the DFU is located likely needs amputation in close future or will undergo a spontaneous amputation or need judgement regarding this risk of amputation by further specialist (o.e. the DFU will not be possible to evaluate regarding healing effects)
- •Diabetes of MOODY type.
- •Current known pregnancy or planned pregnancy during the next 26 weeks by asking the participant.
- •For participation in the sub study of 40 patients taking biopsies the DFU shall not be close to a joint, have direct skeletal contact or risk that such an appear and the DFU should not be ground with granular healing tissue.
- •Participation in another trial evaluating any treatment.
- •Other reasons judged by the investigator that the patient is unsuitable for participation in the study.
- •Persons in need of vascular intervention, critically impaired peripheral circulation (toe pressure < 30 mmHg).
- •Current treatment of malignancy.
- •Event of myocardial infarction or stroke during the last 4 weeks.
结局指标
主要结局
The primary endpoint variable is difference in the time from baseline (randomization) to healing for patients randomized to treatment with HOCl and PHMB evaluated over 24 weeks of treatment measured as hazard ratio.
The primary endpoint variable is difference in the time from baseline (randomization) to healing for patients randomized to treatment with HOCl and PHMB evaluated over 24 weeks of treatment measured as hazard ratio.
次要结局
- Proportion healed DFUs in HOCl group versus PHMB group at week 12.
- The difference in the change of the surface area of the DFU for patients treated with HOCl versus PHMB from baseline (randomization) over 24 weeks.
- The difference in the change of the depth of the DFU for patients treated with HOCl versus PHMB from baseline (randomization) to week 24.
- Difference in the mean number of days of antibiotic treatment for patients treated with HOCl versus PHMB from baseline (randomization) to week 24.
- Difference in the change of quality of life using the EQ5-D questionnaire for patients treated with HOCl versus PHMB from baseline (randomization) to week 24.
研究者
Marcus Lind
Scientific
Vaestra Goetalandsregionen
研究点 (13)
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