A Randomized Trial of Healing Diabetic Foot Ulcers With Hypochlorous Acid and Epidemiologic Studies of Amputations Over Time in Individuals With Diabetes.

Hypochlorous acid (HClO) is excreted of leukocytes important for removing bacteria, biofilm and necrotic tissue, all important for wound-healing. Diabetic foot ulcers (DFU) are the most common cause of amputations.

The overall purpose is to understand if HClO is efficient in healing DFU, understand mechanisms of action and whether use of antibiotics can be reduced.

As a minor part of the project we evaluate contemporary incidences of amputations in persons with diabetes.In a double-blind trial diabetes patients with DFU will be randomized to HClO or the today most commonly recommended antiseptic solution polyhexamine biguanide and treated over 24 weeks.

Registration of antibiotic use will be performed, and biopsies and swabs taken to understand healing and microbiological patterns.

Via Swedish registers we will determine the contemporary incidences of amputations for persons with diabetes and the general population.

In the project group expertise exist of performing randomized trials in persons with diabetes, research and treating diabetic foot ulcers, statistics and microbiological and histological evaluations. The project will be performed years 2022-2026.

Importance: If HClO is efficient in healing DFU it will reduce amputations in persons with diabetes and thereby improve quality of life, working ability and reduce use of antibiotics. It will open new fields for wound treatment. Our epidemiologic study will show current needs and risk groups for amputations.