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

Vastra Gotaland Region

Status: Enrolling

Conditions: Diabetic Foot Ulcer

Treatments: Drug: Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05132179

2020-0011365-36

Details and patient eligibility

About

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.

Full description

202 persons with diabetes and diabetic foot ulcers, DFU will be randomized to treatment with either Hypochlorous Acid, HClO or Polyhexamethylene biguanide, PHMB. The study is double blind and controlled. The cleaning will be done as instruction for PHMB, twice a week until complete healing of the DFU or if not healed 24 weeks. Complete healing is defined as intact skin covering the place where there was an ulcer. Primary objective is time to healing, if cleaning DFU with HClO is more effective in obtaining complete healing of DFU than PHMB. Secondary objectives are to examine if HClO compared with PHMB differ when treating DFU with respect to: a. Proportion of DFU that heals within 12 weeks of treatment, b. The size of the DFU´s surface area over 24 weeks of treatment, c. The depth of the DFU over 24 weeks d. The use of antibiotics over 24 weeks of treatment, e. The quality of life using EQ-5D questionnaire. Explorative objectives are to examine if HClO compared with PHMB differ when treating DFU with respect to: a. Change in healing pattern (sub study in Västra Götaland), b. Change in microbiological variables (sub study in Västra Götaland), c. The quality of life using SF-12 questionnaire, d. Cost effectiveness and other health-economical aspects

Enrollment: 202 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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202 participants in 2 patient groups

HOCl arm

Active Comparator group

Description:

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.

Treatment:

Drug: Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solution

PHMB arm

No Intervention group

Description:

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.