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

NCT05132179 · tracked via the Priya Life Science Sweden tracker

Sponsor

Vastra Gotaland Region

Phase

Not applicable

Started

2022-02-01

Last updated

2024-05-07

Condition(s) studied

Diabetic Foot Ulcer

Investigational drug(s) / intervention(s)

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

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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

Primary outcome measure(s)

Time to healing — 24 weeks
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.

Trial sites (1)

Facility	City	Region	Status
NU sjukvarden	Uddevalla	Trollhattan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05132179 on ClinicalTrials.gov ↗ ← All trials in Sweden