Non-infected superficial diabetes-related foot ulcers Infections and Infestations
Conditions
Interventions
The investigation aims to evaluate the preventive effect of Sorbact® gel dressing and Sorbact® swab when used in conjunction with standard of care (SOC) compared with the control arm SOC.
Control: Tr
Sponsors
BSN medical GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 150 Years
Inclusion criteria
Inclusion criteria: General criteria: 1. At least 18 years old 2. The subject understands and is willing to participate in the clinical study (written informed consent) and can comply with required visits 3. The subject has diabetes and an ulcer (neuropathic, ischemic, and/or neuroischaemic) 4. Diagnosis of either type I or type II diabetes with glycosylated haemoglobin HbA1c = 108 (12%) 5. The target ulcer will be the largest ulcer if two or more eligible DFUs are present and will be the only one evaluated in the study 6. The target ulcer is planned to undergo standard wound care (SWC) therapy Ulcer criteria: 1. Non-infected according to IWGDF 2023 2. WIFI (Wound 1, Ischemia 0,1,2 and Infection 0) 3. Wound area > 1 cm2 4. Ulcer not older than 12 weeks 5. Superficial ulcer not involving tendon, capsule or bone 6. Systemic and/or topical antibiotic treatment wash out of at least 48 hours) 7. Treatment with any antimicrobial dressing wash out of at least 7 days
Exclusion criteria
Exclusion criteria: 1. Target ulcer is deemed by the investigator to be caused by a medical condition other than diabetes. 2. Target ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer. 3. Eligible DFU has associated untreated acute or chronic osteomyelitis or abscess. 4. Clinically infected ulcer (IWGDF 2023: = 2 signs of infection) 5. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy. 6. Pregnant or breast-feeding patients 7. Subject not deemed suitable by the principle investigator for another reason. 8. Sensitivity or allergy to any product component. 9. Participation in another pharmaceutical or medical device study within the last 30 days. 10. Employee (staff or student) of the hospital site (institute) or the sponsor or is in a dependent relationship with a member of site or sponsor staff, e.g. child, spouse etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infections in non-infected diabetic foot ulcers (DFUs) measured by a clinician using the International Working Group on the Diabetic Foot (IWGDF) criteria for wound infection at baseline, and weeks 4,8 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Infection signs and description, as defined by the IWGDF guideline 2023, measured by a clinician weekly and an assessment of general wound pain measured using a visual analogue scale (VAS) at baseline, and weeks 4, 8 and 12 2. Changes to the wound including the appearance of the wound and peri-wound skin as well as the wound size measured by a clinician with a wound ruler at baseline, and weeks 4, 8 and 12 3. Sorbact® device use in the test arm measured by self-reporting of the dressing used and dressing change frequency at baseline, and weeks 4, 8 and 12 4. Health-related quality of life measured using the EQ-5D-5L questionnaire at baseline and week 12, with satisfaction measured at the final visit only 5. Healthcare provider's (HCPs) assessment of treatment success and HCPs satisfaction measured using self-reporting at week 12 6. Sorbact® device safety measured by self-reporting device deficiencies at every study visit | — |
Countries
England, United Kingdom
Contacts
Public ContactHardy Schweigel
Outcome results
None listed