Back to resultsTreating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan
Primary Purpose
Diabetic Foot Ulcer
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solution
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring 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
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
Sites / Locations
- NU sjukvardenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
HOCl arm
PHMB arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
Full Information
NCT ID
NCT05132179
First Posted
September 24, 2021
Last Updated
March 11, 2022
Sponsor
Vastra Gotaland Region
1. Study Identification
Unique Protocol Identification Number
NCT05132179
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vastra Gotaland Region
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, controlled, multi-center, clinical trial with parallel-group design
Masking
ParticipantCare ProviderInvestigator
Masking Description
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
Allocation
Randomized
Enrollment
202 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HOCl arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PHMB arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solution
Other Intervention Name(s)
Dakins
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to healing
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Proportion of DFU that heals within 12 weeks of treatment
Description
Difference in proportion healed DFU between groups at week 12 will be estimated using Fisher´s exact test
Time Frame
12 weeks
Title
Change of DFU´s surface area
Description
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.
Time Frame
24 weeks
Title
Change of diabetic foot ulcer´s, DFU´s, depth
Description
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.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Bergqvist, MD
Phone
+46730961700
Email
karin.bergqvist@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus Lind, Prof
Phone
+46700824239
Email
lind.marcus@telia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Lind, Prof
Organizational Affiliation
University of Gothenburg, Sahlgrenska Academy
Official's Role
Principal Investigator
Facility Information:
Facility Name
NU sjukvarden
City
Uddevalla
State/Province
Trollhattan
ZIP/Postal Code
s-46185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Lind, Prof
Phone
+46700824239
Email
lind.marcus@telia.com
First Name & Middle Initial & Last Name & Degree
Lennart Kareld, MD
12. IPD Sharing Statement
Learn more about this trial
Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan
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