A Randomized Double-blind Clinical Trial Comparing Hypochlorous Acid and Polyhexamethylene Biguanide in Treating Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Time to healing
研究概览
简要总结
202 Diabetic foot ulcers will be cleaned with either Hypochlorous Acid, HClO or Polyhexamethylene biguanide, PHMB twice a week until healed or 24 weeks. Primary objective is to find out if cleaning DFU with HClO is more effective in obtaining complete healing than PHMB.
详细描述
202 persons with diabetes and diabetic foot ulcers, DFU will be randomized to treatment with either Hypochlorous Acid, HClO or Polyhexamethylene biguanide, PHMB. The study is double blind and controlled. The cleaning will be done as instruction for PHMB, twice a week until complete healing of the DFU or if not healed 24 weeks. Complete healing is defined as intact skin covering the place where there was an ulcer. Primary objective is time to healing, if cleaning DFU with HClO is more effective in obtaining complete healing of DFU than PHMB. Secondary objectives are to examine if HClO compared with PHMB differ when treating DFU with respect to: a. Proportion of DFU that heals within 12 weeks of treatment, b. The size of the DFU´s surface area over 24 weeks of treatment, c. The depth of the DFU over 24 weeks d. The use of antibiotics over 24 weeks of treatment, e. The quality of life using EQ-5D questionnaire. Explorative objectives are to examine if HClO compared with PHMB differ when treating DFU with respect to: a. Change in healing pattern (sub study in Västra Götaland), b. Change in microbiological variables (sub study in Västra Götaland), c. The quality of life using SF-12 questionnaire, d. Cost effectiveness and other health-economical aspects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The wound irrigation solutions will be filled in identical 5 ml syringes, marked with study number and date of filling. To mask the smell of chlorine a tin without lid with 15 ml 5% chloride will be placed maximally 1 meter from the treating place
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before trial-related activities,
- •Diabetes Mellitus type 1 or 2 or due to pancreatitis
- •Foot ulcer since 3 weeks or more
- •Ulcer surface area 9 mm2 or more
- •Age 18 years old or more
排除标准
- •Persons in need of intensive care or dialysis
- •Persons in need of vascular intervention, critically impaired circulation (toe-pressure < 30 mm Hg)
- •Event of myocardial infarction or stroke during the last three months
- •Debut of atrial fibrillation or heart failure during the last three months
- •Current treatment of malignancy
- •Treatment with corticosteroids with a dose corresponding to 50 mg Prednisolon
- •Severe wound infection according to International Working Group of Diabetic Foot, IWGDF at least two of following signs: body temperature <36 C or >38 C, heart rate >90/minute, respiration rate >20/minute, LPK >12x10^9/L
- •Planned changed residence in the coming 12 months requiring change of clinic for wound treatment during the follow-up time
- •Age under 18 years old
- •Diabetes of MOODY type
- •Current known pregnancy or planned pregnancy next 26 weeks
- •Participation in another clinical trial evaluating any treatment
- •Other reasons judged by the investigator that the patient is unsuitable for participation in the study
研究组 & 干预措施
HOCl arm
Dakin´s Solution, with the active substance Hypochlorous Acid, HOCl was first invented 1915 for use on infected war wounds. The DFU will be cleaned with HOCl twice a week. The treatment will be performed in accordance with instructions for Prontosan, PHMB.
干预措施: Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solution (Drug)
结局指标
主要结局
Time to healing
时间窗: 24 weeks
The primary efficacy analysis of difference in time to healing from randomisation up to 24 weeks between the two randomised groups. Analysis will be performed using Cox regression. The healing date will be defined as the first visit when the ulcer is fully covered with skin.
次要结局
- Change of diabetic foot ulcer´s, DFU´s, depth(24 weeks)
- Proportion of DFU that heals within 12 weeks of treatment(12 weeks)
- Change of DFU´s surface area(24 weeks)
研究者
Marcus Lind
Professor, consultant Endocrinology
Vastra Gotaland Region