Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan
Diabetic Foot Ulcer
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic foot ulcer, DFU, Healing, Dakin´s solution, Prontosan Wound Irrigation Solution, Antibiotic consumption, Healing pattern, Microbiological variables, Cost-effectiveness, Diabetes type 1 and 2, Topical antimicrobial agent, Hypochlorous Acid, PHMB, Topical treatment
Eligibility Criteria
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
Exclusion Criteria:
- 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
Sites / Locations
- NU sjukvardenRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
HOCl arm
PHMB 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.
Prontosan, with the active substance PHMB, is recommended by 19 out of 21 regions in Sweden, for cleaning DFU. The DFU will be cleaned with PHMB twice a week. The treatment will be performed in accordance with instructions for Prontosan, PHMB.