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

NCT05132179 | Recruiting

• 1 other identifier: 2020-0011365-36
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of DFU that heals within 12 weeks of treatment

  12 weeks

• Change of DFU´s surface area

  24 weeks

• Change of diabetic foot ulcer´s, DFU´s, depth

  24 weeks

Study Arms (2)

HOCl arm

ACTIVE COMPARATOR

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.

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

PHMB arm

NO INTERVENTION

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.

Interventions

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

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.

Also known as: Dakins

HOCl arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

NU sjukvarden

Uddevalla, Trollhattan, s-46185, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus, Type 1

Interventions

Solutions

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Marcus Lind, Prof

  University of Gothenburg, Sahlgrenska Academy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Bergqvist, MD

CONTACT

+46730961700; karin.bergqvist@vgregion.se

Marcus Lind, Prof

CONTACT

+46700824239; lind.marcus@telia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The wound irrigation solutions will be filled in identical 5 ml syringes, marked with study number and date of filling. To mask the smell of chlorine a tin without lid with 15 ml 5% chloride will be placed maximally 1 meter from the treating place
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, consultant Endocrinology

Model Details: Randomized, double-blind, controlled, multi-center, clinical trial with parallel-group design

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: November 24, 2021
• Study Start: February 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

SE (1)