Chronic, non-ischemic, non-healing diabetic foot ulcer (DFU) Skin and Connective Tissue Diseases Ulcer of lower limb, not elsewhere classified
Conditions
Interventions
The Implantable Medical Device (IMD) is a CE-certified product classified as a Class III medical device according to Directive 93/42/EEC and MDR 2017/745. The IMD is available as a sterile, single use
Sponsors
IBSA Institut Biochimique S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male and female outpatients aged =18 years 2. Subject being diagnosed with type 1 or type 2 diabetes 3. Subject diagnosed with plantar neuropathic DFU (positive Semmes-Weinstein 10 g Monofilament test) 4. Chronic DFU present from =4 weeks and = 24 weeks 5. DFU cross-sectional area of =1 cm² and =10 cm² 6. DFU of grade 1A-1B or 2A-2B according to the University of Texas Staging System for Diabetic Foot Ulcers 7. DFU Grade 1/uninfected or Grade 2/mild infected according to Infectious Diseases Society of America (IDSA) classification 8. Glycated haemoglobin HbA1c value =9% at Screening or within 3 months prior to inclusion 9. Presence of dorsalis and posterior tibial pulses and Ankle-Brachial Pressure Index (ABPI) value =0.9 and =1.2 at Screening or within 3 months prior to inclusion 10. No surgery at the limb of interest within 1 month prior to inclusion 11. Performance status Eastern Cooperative Oncology Group (ECOG) 0-1 12. Subject provided written informed consent to participate in the study obtained according to Good Clinical Practice (GCP) 13. Subject able to comprehend the full nature and the purpose of the study, including possible risks and side effects, and subjects able to cooperate with the Investigator and to comply with the requirements of the entire study (including the ability to attend all the planned study visits according to the time limits, have access to the internet via a computer, iPad, iPhone or Android device), based on Investigator’s judgement 14. Females of childbearing potential (i.e., not permanently sterilised - post-hysterectomy or tubal ligation status – or not postmenopausal) must have a negative pregnancy test result at Screening and must use an appropriate method of contraception for at least 30 days before inclusion in the study and during the whole study period, according to the definition in ICH M3 Guideline: a highly effective method is defined as those which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.
Exclusion criteria
Exclusion criteria: 1. DFU of ischemic or neuroischemic origin (ABPI 30% during the 2-week run-in period of the study, i.e. between V1 and V2 3. Infected DFU at the end of the run-in period, i.e. V2 4. Superinfected DFU (Grade 3-4 according to IDSA classification) including osteitis 5. Presence of necrotic tissue on the target DFU bed 6. DFU with exposed tendon or bone 7. Active Charcot’s foot 8. Presence of more than one plantar DFU in the limb of interest 9. Presence of plantar DFUs in both limbs Treatment-specific exclusion criteria: 10. Concomitant treatment or treatment within 3 months prior to the enrolment with medications known to adversely affect the healing process or suspected of compromising the subject's immune system: i.e., systemic corticosteroids, cytostatic drugs, immunosuppressive agents 11. Treatment with topical antibiotics in the target wound area 12. Allergy to components contained in the IP 13. History of anaphylaxis or allergic reactions to any other allergens potentially affecting the study outcome General exclusion criteria: 14. Clinically significant or unstable underlying/concurrent disease whose sequelae or treatment might interfere with the evaluation of study parameters, including autoimmune diseases, such as rheumatoid arthritis, vasculitis; immunocompromised states, such as HIV infection 15. Severe anemia (haemoglobin 25 cigarettes/day) 19. Major psychiatric disorders that, in the view of the Investigator, could compromise the patient’s participation in the study 20. Positive or missing pregnancy test at the screening visit, or breastfeeding women 21. Concomitant participation in other clinical trials or participation in the evaluation of any IMDs/IMPs during 3 months before this study or previous participation in the same study 22. Participation in the study is also not permitted to employees of the Investigator or study centre with direct involvement in the trial or in other trials under the direction of that Investigator, as well as family members of the employees or the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the IMD assessed using the incidence of adverse events (AEs) and, specifically, treatment-emergent AEs (TEAEs) occurring at any time during the study (Common Terminology Criteria for Adverse Events v.5.0) (incidence, severity, duration, and causal relationship with the investigational product (IP) assessment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the IMD assessed using: 1. Treatment-related TEAEs (i.e., adverse device effects [ADEs]) and serious TEAEs occurring at any time during the study 2. Infection incidence at the target ulcer and duration (days) of systemic antibiotherapy 3. Incidence of limb amputation (minor and major) needed at any time during the study 4. Overall treatment tolerability, independently judged by the Investigator and subject using a 5-point scale (4 = excellent; 3 = good; 2 = fair; 1 = poor; 0 = none) at the end of the study 5. Vital signs (systolic blood pressure, diastolic blood pressure, heart rate) measured at each visit (from screening to visit 9 and follow up visit) 6. Serum creatinine, ALT, complete blood count, and proteinuria measured at screening and Visit 9 7. Subject’s exposure (mean number of IP dressings used) during the whole study period Performance of the IMD assessed using: 1. Proportion (%) of target ulcers closed =12 weeks (ITT) (defined as 100% re-epithelialization and no drainage) and confirmed at the follow-up visit 2 weeks later, as assessed by the investigators at the investigational site 2. Percent (%) reduction of the wound area measured with a standardised digital picture and validated image analysis software at each control visit 3. Time (days) elapsed from the first IP application until complete ulcer closure, defined as 100% re-epithelialization and no drainage 4. Overall treatment performance (easiness of IP manipulation, IP efficacy), judged by the Investigator using a 5-point scale (4 = excellent; 3 = good; 2 = fair; 1 = poor; 0 = none) at the end of the study Subject’s assessment of their quality of life and their satisfaction with the treatment assessed using: 1. Subject’s quality of life (QoL) assessed by the subject using the SF-36 questionnaire at the screening visit and visit 9 2. Treatment satisfaction judged by the subject using a 5-point scale (4 = excellent; 3 = good; 2 = fair; 1 = poor; 0 = none) at the end of the study | — |
Countries
Poland
Contacts
Public ContactSerena Caverzasio
Outcome results
None listed