Cleaning infected foot ulcers in people with diabetes: compairing two different solutions, which is best?

A randomized double-blind clinical trial comparing Hypochlorous Acid and Polyhexamethylene biguanide in treating diabetic foot ulcers - Dakin´s - Diabetes

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001365-36-SE

Enrollment

202

Registered

2020-09-29

Start date

2021-06-28

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infected foot ulcers in people with diabetes

Interventions

Trade Name: Dakin´s solution Product Name: Dakin´s Solution Pharmaceutical Form: Cutaneous solution INN or Proposed INN: Dakin´s solution CAS Number: 7681-52-9 Other descriptive name: SODIUM HYPOCHLOR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: To be included the subject must meet the following criteria: • Written and verbal informed consent given before trial-related activities • Diabetes type 1, type 2 or diabetes due to pancreatitis • Foot ulcer = 10 days • Ulcer surface area = 9 mm2 • Age 18 years old or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 152

Exclusion criteria

Exclusion criteria: Under 18 years old, serious infection (temp 38, heartrate >90 beats/minute, resp rate >20/min, LPK >12X10?9), condition needing intensive care and dialysis, treatment with immunotherapy and/or corticosteroids = 50 mg/day, event of myocardial infarction or stroke during the last 4 weeks, debut of atrial fibrillation or heart failure (ejection fraction <40 %) during the last 4 weeks

Design outcomes

Primary

Measure	Time frame
Main Objective: Time to healing;Secondary Objective: The secondary objectives of this trial are to evaluate if treatment with HClO and PHMB in treating DFU differ 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 of treatment d.Use of antibiotics over 24 weeks of treatment e.Quality of life over 24 weeks of treatment using the EQ-5D questionnaire ;Primary end point(s): Difference in time to healing of DFU for patients randomized to hypochlorous acid (HClO) compared with those randomized to Polyhexamethylene biguanide (PHMB) from baseline (randomization) over a maximal follow-up of 24 weeks.;Timepoint(s) of evaluation of this end point: The participants wil be treated until the ulcer has healed or at the most 24 weeks	—

Measure

Time frame

Main Objective: Time to healing;Secondary Objective: The secondary objectives of this trial are to evaluate if treatment with HClO and PHMB in treating DFU differ 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 of treatment d.Use of antibiotics over 24 weeks of treatment e.Quality of life over 24 weeks of treatment using the EQ-5D questionnaire ;Primary end point(s): Difference in time to healing of DFU for patients randomized to hypochlorous acid (HClO) compared with those randomized to Polyhexamethylene biguanide (PHMB) from baseline (randomization) over a maximal follow-up of 24 weeks.;Timepoint(s) of evaluation of this end point: The participants wil be treated until the ulcer has healed or at the most 24 weeks

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Secondary

Measure	Time frame
Secondary end point(s): a. Proportion healed DFUs in HClO group versus PHMB group at week 12 b. The difference in the change of the surface area of the DFU for patients treated with HClO versus PHMB from baseline (randomization) over 24 weeks. c. The difference in the change of the depth of the DFU for patients treated with HClO versus PHMB from baseline (randomization) to week 24. d. Difference in the mean number of days of antibiotic treatment for patients treated with HClO versus PHMB from baseline (randomization) to week 24. e. Difference in the change of quality of life using the EQ5-D questionnaire for patients treated with HClO versus PHMB from baseline (randomization) to week 24. ;Timepoint(s) of evaluation of this end point: Randomisering, week 12, when healed and week 24	—

Measure

Time frame

Secondary end point(s): a. Proportion healed DFUs in HClO group versus PHMB group at week 12 b. The difference in the change of the surface area of the DFU for patients treated with HClO versus PHMB from baseline (randomization) over 24 weeks. c. The difference in the change of the depth of the DFU for patients treated with HClO versus PHMB from baseline (randomization) to week 24. d. Difference in the mean number of days of antibiotic treatment for patients treated with HClO versus PHMB from baseline (randomization) to week 24. e. Difference in the change of quality of life using the EQ5-D questionnaire for patients treated with HClO versus PHMB from baseline (randomization) to week 24. ;Timepoint(s) of evaluation of this end point: Randomisering, week 12, when healed and week 24

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Countries

Sweden

Contacts

Public ContactMarcus Lind

NU-hospital Group

nusjukv.kansli@vgregion.se4610435 00 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026