Clinical investigation to evaluate the performance and safety profile of a new dressing in the treatment of chronic, non-ischemic, non-healing diabetic foot ulcers, in association with the standard of care
- Conditions
- Chronic, non-ischemic, non-healing diabetic foot ulcer (DFU)Skin and Connective Tissue DiseasesUlcer of lower limb, not elsewhere classified
- Registration Number
- ISRCTN11013503
- Lead Sponsor
- IBSA Institut Biochimique S.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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.
1. DFU of ischemic or neuroischemic origin (ABPI <0.9)
2. DFU which cross-sectional area diminished >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 <8 g/dl) or hypoalbuminemia (albumin <2.5 g/dl) indicating a poor nutritional status (<3 months prior to inclusion)
16. Subject suffering from severe hepatic disorders (with serum activity of ALT/AST =2.5 UNL) or severe renal disorders (creatinine clearance <30 ml/min) (<3 months prior to inclusion)
17. Presence of severe cardiac/cardiovascular conditions, i.e. NYHA Class III and IV congestive heart failure (CHF)
18. Subjects with a history of alcohol or drug abuse (within the previous 12 months), or heavy smoker (>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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method