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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vastra Gotaland Region
• Treatments: Eusol; Sodium Hypochlorite

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