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

Diabetic Foot Ulcer Clinical Trial

Official title:

A Randomized Double-blind Clinical Trial Comparing Hypochlorous Acid and Polyhexamethylene Biguanide in Treating Diabetic Foot Ulcers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05132179
• Other study ID #: 2020-0011365-36
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Vastra Gotaland Region
• Contact: Karin Bergqvist, MD
• Phone: +46730961700
• Email: karin.bergqvist[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Drug:
• Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solution
Dakin´s solution is a 50/50 mixture of 1% sodiumhypochlorite and 2% sodiumhydrocarbonate, the mixture is a 0,5% chlorine solution. Dakin´s solution is not used in Sweden on wound. Dakin´s solution is only used in dental care in Sweden.

Locations

Country	Name	City	State
Sweden	NU sjukvarden	Uddevalla	Trollhattan

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to healing	The primary efficacy analysis of difference in time to healing from randomisation up to 24 weeks between the two randomised groups. Analysis will be performed using Cox regression. The healing date will be defined as the first visit when the ulcer is fully covered with skin.	24 weeks
Secondary	Proportion of DFU that heals within 12 weeks of treatment	Difference in proportion healed DFU between groups at week 12 will be estimated using Fisher´s exact test	12 weeks
Secondary	Change of DFU´s surface area	The size of surface area measured with a mm ruler in photo of the DFU. The surface area of The DFU will be measured weekly for 24 weeks or until healed from weekly photo with a mm ruler in the photo. The calculation of the area will be done by a person not involved in the treatment. For each participants and time point, the percentage change of the ulcer size (area and volume) will be calculated in relation to randomisation. For each group (HOCl and PHMB, respectively), the average change in ulcer size (area and volume) will be calculated, whereafter any difference between the two groups will be examined for statistical significance.	24 weeks
Secondary	Change of diabetic foot ulcer´s, DFU´s, depth	The depth of diabetic foot ulcer measured with digital pair of calipers weekly for 24 weeks or until healed. For each participant and time point, the percentage change of the ulcer size (area and volume) will be calculated in relation to the date of randomisation. For each group (HOCl and PHMB, respectively), the average change in ulcer size (area and volume) will be calculated, whereafter any difference between the two groups will be examined for statistical significance.	24 weeks