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

May 6, 2024 updated by: Marcus Lind, Vastra Gotaland Region

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
202

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
    • Trollhattan
      • Uddevalla, Trollhattan, Sweden, s-46185
        • Recruiting
        • NU sjukvarden
        • Contact:
        • Contact:
          • Lennart Kareld, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: HOCl arm
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
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.
Other Names:
  • Dakins
No Intervention: PHMB arm
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to healing
Time Frame: 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.
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of DFU that heals within 12 weeks of treatment
Time Frame: 12 weeks
Difference in proportion healed DFU between groups at week 12 will be estimated using Fisher´s exact test
12 weeks
Change of DFU´s surface area
Time Frame: 24 weeks
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
Change of diabetic foot ulcer´s, DFU´s, depth
Time Frame: 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marcus Lind, Prof, University of Gothenburg, Sahlgrenska academy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-0011365-36

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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