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

Phase 1

• Conditions: Infected foot ulcers in people with diabetes; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-001365-36-SE
• Lead Sponsor: -hospital Group/Västra Götalandsregionen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-29
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 202

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

Under 18 years old, serious infection (temp <36 or >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified