Diabetic Foot UlcerNCT05132179
Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan
A study testing Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solution in people with Diabetic Foot Ulcer, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
NU sjukvarden
Uddevalla, Trollhattan, s-46185
Marcus Lind, Prof, +46700824239, lind.marcus@telia.com
Lennart Kareld, MD
About this study
Official title: 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.
Read the 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
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solution
- 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
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solutionDrug
Also called Dakins
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (3)
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
Measured: 12 weeks
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.
Measured: 24 weeks
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, controlled, multi-center, clinical trial with parallel-group design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marcus Lind, Vastra Gotaland Region
- Investigators
- Marcus Lind, Prof, Principal investigator, University of Gothenburg, Sahlgrenska Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132179
- Sponsor's protocol ID
- 2020-0011365-36
- Status last verified
- May 2024
- First submitted
- 24 Sep 2021
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Clinical Trial Comparing Hypochlorous Acid and Polyhexamethylene Biguanide in Treating Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05132179
- Acronym / sponsor ID
- 2020-0011365-36
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, controlled, multi-center, clinical trial with parallel-group design
| Arm | Type | Receives |
|---|---|---|
| HOCl arm | Active comparator | Drug: Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solutionDakin´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. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solutionAlso: DakinsDakin´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. | Drug | HOCl arm |
Primary outcome
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.
3 secondary outcomes
Proportion of DFU that heals within 12 weeks of treatment
Time frame: 12 weeks
Change of DFU´s surface area
Time frame: 24 weeks
Change of diabetic foot ulcer´s, DFU´s, depth
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
Related trials for Diabetic Foot Ulcer
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcus Lind, Prof principal investigator
University of Gothenburg, Sahlgrenska Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solution in people with Diabetic Foot Ulcer, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karin Bergqvist, MD (+46730961700, karin.bergqvist@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to healing (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.