NCT05132179 Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan
| NCT ID | NCT05132179 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Diabetic Foot Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 202 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 202 participants in total. It began in 2022-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Frequently Asked Questions
Who can join the NCT05132179 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Diabetic Foot Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05132179 currently recruiting?
Yes, NCT05132179 is actively recruiting participants. Visit ClinicalTrials.gov or contact Vastra Gotaland Region to inquire about joining.
Where is the NCT05132179 trial being conducted?
This trial is being conducted at Uddevalla, Sweden.
Who is sponsoring the NCT05132179 clinical trial?
NCT05132179 is sponsored by Vastra Gotaland Region. The trial plans to enroll 202 participants.