3. Diabetic foot ulcer treated unsuccessfully for at least 4 weeks with mean diameter between 1.5 and 4 cm after débridement
Conditions
Sponsors
DermaTools Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient must have given written informed consent. 2. Age: =18 years, inclusive of the date of randomization. 3. Diabetic foot ulcer with mean diameter between 1.5 and 4 cm after débridement (1.5 and 4 cm if debridement is not indicated), determined as longest length + longest width)/2 • Wound shapes other than circular must have both a length and width of at least 1.5 cm. • Wound stage Wagner grade I or II, Armstrong stadium A or C (for Wagner-Armstrong-Classification see Appendix 1), treated unsuccessfully for at least 4weeks. • The duration of non-healing ulcer presence prior to study should be at least 4 weeks Should more than one eligible wound be present, only one will be selected by the investigator, not closer than 3 cm to adjacent ulcers (“target wound”). Note: Other wounds with impaired healing, e.g. decubitus ulcer, arterial and/or venous leg ulcer, Charcot's foot or malum perforans, may be present in the same patient but shall not be selected as targets for the present study. 4. Type 1 or type 2 Diabetes Mellitus under metabolic control as confirmed by a glycosylated hemoglobin (HbA1c) = 12% at screening. The laboratory results may not be older than 3 month at the date of randomization. 5. Adequate perfusion of the lower leg on the affected side determined by either: • an ankle / brachial ratio of > 0.7 • or systolic blood pressure of either > 50 mm Hg (big toe) • or > 70 mm Hg (dorsalis pedis) as determined by an appropriate method, according to local use, concerning the foot pulse to exclude patients who require a revascularization therapy; examination results should be not older than 3 months. 6. Females of non-childbearing potential defined as being amenorrhoeic for longer than 2 years with an appropriate clinical profile or surgically sterile. • If of childbearing potential the patient must use an adequate birth control and must have a negative pregnancy test. 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 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: 1. Clinical evidence of ulcer bed infection requiring treatment with topical or systemic antibiotics 2. Suspicion of bone infection or osteomyelitis* affecting the area of target wound. 3. An ulcer primarily ischemic in etiology Note: The ulcer is primarily ischemic in etiology as diagnosed by an ABI of = 0.7 on the affected extremity or systolic pressure of = 50 mmHg (great toe) or = 70 mmHg (dorsalis pedis). 4. Revascularisation of the affected leg done less than 3 months before randomization or planned revascularization procedure. 5. Start or change of a new off-loading strategy (already existing off-loading device at the investigator´s discretion, is optimally applied and must be maintained). 6. Clinically significant abnormal values in clinical chemistry except those typical for the underlying diseases mentioned in the inclusion criteria (for ranges see laboratory manuals of the laboratories of the participating sites/ countries). These exceptions are at the discretion of the Investigator and taken into account the tolerated ranges given in the table in Section 11.3.9. Note. Patients with a high blood glucose level are eligible, provided HbAc1 = 12% at screening. 7. Severe or uncontrolled heart disease (NYHA class III or IV, see Appendix 2). 8. Diagnosis of renal failure or treatment with dialysis. 9. Active severe hepatic disease, which might have an impact on wound healing. 10. Concurrent illness or a condition that may interfere with wound healing other than those mentioned in the inclusion criteria (e. g. carcinoma, haematological disease, vasculitis, connective tissue disease, alcohol neuropathy). 11. Previous radiation of the region of the target wound selected for the study. 12. Exposure of any systemic immunosuppressive or cytostatic therapy or growth factors during the previous 30 days prior to the study, including the day Informed Consent is given. 13. Severe psychiatric or neurological disorder. 14. Incapability of giving informed consent. 15. Co-worker, student, relative or spouse of the investigator. 16. Previous participation in this present study. 17. Participation in another experimental clinical study during the previous 3 months prior to entry into the present study. 18. Current drug or alcohol abuse. 19. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patients at risk because of participation in the trial, or may influence the result of the trial, or the patient’s ability to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to confirm the superiority of 1.2 mM DPOCl compared to vehicle solution in achieving complete wound closure in the tested sample of patients with Diabetic Foot Ulcer ;Secondary Objective: Secondary efficacy objective(s) • To describe efficacy of DPOCl 1.2 mM solution • To obtain data on the occurrence of wound infections • To obtain data on the improvement of symptoms, signs and QoL Safety objective(s) • To obtain safety and tolerability data for treatment with DPOCl 1.2 mM solution ;Primary end point(s): The primary endpoint is the rate of subjects achieving complete wound closure (CWC, responder). ;Timepoint(s) of evaluation of this end point: Weekly | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to complete wound closure for each treatment group. Determination of time point (date) at which CWC confirmed by the independent adjudicator was first observed for each patient by the investigator, if CWC 2. Sustainability of wound closure for each treatment group compared to reference. 3. Relative wound area reduction (percentage change between last visit (EOT) and baseline as compared to baseline), as measured by computerised wound area determination. The percent changes from baseline to each visit will also be evaluated. 4. Wound area reduction (change between last visit (EOT) and baseline), as measured by computerised wound area determination. The changes from baseline to each visit will also be evaluated. 5. Course of wound area reduction over time. 6. Occurrence of wound infection 7. Improvement of symptoms (e.g. itching, pain, wellbeing). Evaluation of symptoms improvement assessed by a Visual Analogue Scale (VAS). 8. Improvement of symptoms and signs (e.g. prickling, heat sensation, cold sensation, numbness, furry feeling, smell, exudation). Measurement of symptoms improvement by a rating scale. 9. Quality of Life A validated standardised QoL questionnaire, EQ-5d, will be used at base line and EoT visit. Exploratory end point: Proportion of patients requiring systemic antibiotic intervention.due to occurrence of wound infection ;Timepoint(s) of evaluation of this end point: Weekly | — |
Countries
Austria, Georgia, Germany, Latvia, Poland
Contacts
Public ContactClinical Operations
DermaTools Biotech GmbH
Outcome results
None listed