Comparing two antiseptic cleaning solutions for diabetic foot ulcers
Compares hypochlorous acid and polyhexamethylene biguanide for cleaning diabetic foot ulcers.
Plain-language title generated from the registry record
Registry title: Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan
Key facts
- Where
- Uddevalla, SwedenSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT05132179, who can take part
Where in Sweden
- NU sjukvardenUddevalla, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vastra Gotaland Region
- Trial code
- NCT05132179
- Record updated
- 7 May 2024
- Original description
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.Read full original descriptionShow less
A Randomized Double-blind Clinical Trial Comparing Hypochlorous Acid and Polyhexamethylene Biguanide in Treating Diabetic Foot Ulcers
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.
Inclusion: 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.
Exclusion: Treatment with corticosteroids with a dose corresponding to 50 mg Prednisolon; 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; 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; Diabetes of MOODY type; Age under 18 years old; Persons in need of intensive care or dialysis; Persons in need of vascular intervention, critically impaired circulation (toe-pressure < 30 mm Hg); Planned changed residence in the coming 12 months requiring change of clinic for wound treatment during the follow-up time; 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.