Wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin. MedDRA version: 12.1 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer
Conditions
Sponsors
Olympus France SAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent to participate. 2. Male or female patients age 18 years or older. 3. Type 1 or 2 diabetes. 4. A single full-thickness DFU that has been present for at least 2 weeks. 5. DFU surface area =1 cm2 and =20 cm2 confirmed by the investigator’s measurement, and its surface area not decreased by more than 40% compared to the selection value. 6. No exposure of bone in the target DFU. 7. Neuropathy confirmed by loss of protective sensation to monofilament test. 8. Non-infected target foot DFU of confirmed neuropathic origin with confirmed ABPI on the leg with the target DFU =0.7 and =1.3, and, toe blood pressure >40 mmHg (to exclude predominant ischemia requiring further exploration and treatment). 9. Completed the 2-week placebo run-in period during which they were compliant to off-loading and to daily application of placebo spray, without major protocol violation. Compliance with the placebo run-in treatment regimen must be “excellent” or “acceptable”. 10. Glycosylated hemoglobin (HbA1c) =10% (from a blood sample taken during the placebo run-in period). 11. Target DFU appropriately debrided (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Active Charcot foot, or inactive Charcot foot, if the target DFU cannot be properly offloaded. 2. Ulcers of non-neuropathic origin (e.g., rheumatoid, radiation-related, vasculitis-related ulcers). 3. Presence of any foot ulcer (whether or not on the target foot) for which local or systemic antibiotic treatment is required. 4. Evidence of skin cancer within or adjacent to the target ulcer. 5. Any infected ulcers, defined as any problem such as (but not limited to) cellulitis, osteomyelitis, gangrene, or deep tissue infection requiring local or systemic antibiotic therapy. 6. Another wound on the same limb as the target DFU, even if the other wound does not involve the foot. 7. Any known active malignancy that requires general, local, surgical or radiation therapy either ongoing or within the previous 6 months; or patients whose treatment has been suspended for compassionate reasons, or who are not considered as cured from any malignancy. 8. Morbid obesity, defined as body mass index (BMI) =40 kg/m2. 9. Clinically significant medical conditions, in the investigator’s opinion, that could impair wound healing (e.g. hepatic impairment, immunocompromised patients). 10. Severe renal failure, defined as requirement for hemodialysis or peritoneal dialysis. 11. Females who are pregnant or breastfeeding, or who are of childbearing potential and not practicing a medically approved method of contraception. 12. Concomitant treatment with high dose oral or parenteral corticosteroids, defined as a daily dose of at least 7.5 mg prednisone or equivalent. 13. Participation in another clinical study within the previous 3 months. 14. Current participation in another clinical study with any drug or device. 15. History of drug or alcohol abuse within the previous year. 16. Concurrent severe psychiatric disease (including severe depressive disorder). 17. Known intolerance to the IMP or to any of its excipients. 18. Known to be uncooperative or noncompliant. 19. Outpatients who are unable to comply with the requirement for daily spray application at home (either application by a family member or by a visiting nurse). 20. Any other condition which, in the opinion of the investigator, would render the patient unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care. Wound closure is defined as 100% reepithelialization of the target DFU, without drainage.;Secondary Objective: • To determine the time to reach complete wound closure. • To determine absolute and relative wound area regression and wound edge migration based on planimetry tracing. • To determine the occurrence rate of clinical infection on the target DFU. • To evaluate the safety of trafermin 0.01% spray. • To determine the rate of amputations on the target DFU. • To determine the frequency of local mechanical or surgical procedures. • To determine the maintenance of wound closure/time to re-opening up to 3 months after observed reepithelialization. • To determine DFU new occurrence/recurrence up to 12 months. • To explore biomarkers from target wound fluid (selected centers only). • To assess high sensitivity C-Reactive Protein (hs CRP) level variations. • To explore the correlation of absolute and relative wound area regression and wound edge migration based on photography in comparison with planimetry tracing. ;Primary end point(s): Wound closure is defined as observed 100% reepithelialization of the target DFU, without drainage, confirmed by a second medical evaluation after two weeks. The wound closure rate is the number of patients achieving wound closure at the specified timepoint during the 12-week double blind treatment period. | — |
Countries
Belgium, Denmark, Germany, Hungary, Netherlands, Sweden, United Kingdom
Outcome results
None listed