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

Summary

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.

Eligibility

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

Conditions2

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