Clinical trial NCT05132179: Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan
Official title: A Randomized Double-blind Clinical Trial Comparing Hypochlorous Acid and Polyhexamethylene Biguanide in Treating Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic foot ulcer, DFU
Healing
Dakin´s solution
Prontosan Wound Irrigation Solution
Antibiotic consumption
Healing pattern
Microbiological variables
Cost-effectiveness
Diabetes type 1 and 2
Topical antimicrobial agent
Hypochlorous Acid
PHMB
Topical treatment
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2021-11-24
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, controlled, multi-center, clinical trial with parallel-group design
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility 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

Primary outcomes:
measure: Time to healing
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of DFU that heals within 12 weeks of treatment
timeFrame: 12 weeks
measure: Change of DFU´s surface area
timeFrame: 24 weeks
measure: Change of diabetic foot ulcer´s, DFU´s, depth
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Uddevalla
country: Sweden
facility: NU sjukvarden
state: Trollhattan
Study officials:
affiliation: University of Gothenburg, Sahlgrenska Academy
name: Marcus Lind, Prof
role: PRINCIPAL_INVESTIGATOR
References: