Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan

Официальное название

A Randomized Double-blind Clinical Trial Comparing Hypochlorous Acid and Polyhexamethylene Biguanide in Treating Diabetic Foot Ulcers

Обзор

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.

Подробное описание

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

Вмешательства

• Препарат Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solution
  Dakin´s solution is a 50/50 mixture of 1% sodiumhypochlorite and 2% sodiumhydrocarbonate, the mixture is a 0,5% chlorine solution. Dakin´s solution is not used in Sweden on wound. Dakin´s solution is only used in dental care in Sweden.

Первичные конечные точки

• Time to healing [Срок оценки: 24 weeks]

Вторичные конечные точки (3)

• Proportion of DFU that heals within 12 weeks of treatment [Срок оценки: 12 weeks]
• Change of DFU´s surface area [Срок оценки: 24 weeks]
• Change of diabetic foot ulcer´s, DFU´s, depth [Срок оценки: 24 weeks]

Критерии участия

Inclusion Criteria: 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• NU sjukvarden — Uddevalla

Идентификаторы

NCT: NCT05132179 · 2020-0011365-36

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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