Diabetic foot ulcer with mean diameter between 1.5 and 4 cm after débridement if indicated), Wound stage Wagner grade I or II, Armstrong stadium A or C (for Wagner-Armstrong-Classification), treated unsuccessfully for at least 4weeks.
Conditions
Interventions
Product Name: DermaPro®
Product Code: DPOCl
Pharmaceutical Form: Concentrate for cutaneous solution
INN or Proposed INN: Diperoxochloric acid sodium sal
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 treated unsuccessfully for at least 4weeks. Should more than one eligible wound be present, only one will be selected (“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 extremity determined by 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1.Local antibiotic therapy of the target wound selected for the study. 2.Suspicion of bone infection or osteomyelitis* affecting the area of target wound. 3.Peripheral arterial occlusive disease in the pelvic region or lower. Note: The ulcer is primarily ischemic in etiology as diagnosed by an ABI of = 0.7 on the affected extremity extremities or systolic pressure of = 50 mmHg (great toe) or = 70 mmHg (dorsalis pedis). 4.Vascular reconstruction or angioplasty less than 3 months ago 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 (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 Section 11.3.8. 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.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, hematological disease, vasculitis, connective tissue disease, alcohol neuropathy). 11.Previous radiation of the region of the target wound selected for the study. 12.Exposure to any systemic immunosuppressive or cytostatic therapy 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
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Wound area reduction (change between last visit and baseline), as measured by computerised wound area determination. •Percentage of patients achieving complete wound closure. •Time to complete wound closure •Sustainability of wound closure within the 12 week treatment time frame. •Course of wound closure over time. •Improvement of subjective symptoms (itching, pain, well-being using Visual Analogue Scores (VAS)) •Improvement of objective clinical symptoms (prickling, heat sensation, cold sensation, numbness, furry feeling, smell, exudation) ;Timepoint(s) of evaluation of this end point: Weekly | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Wound area reduction (percentage change between last visit and baseline as compared to baseline), as measured by computerised wound area determination; Secondary Objective: •Wound area reduction (change between last visit and baseline), as measured by computerised wound area determination. •Percentage of patients achieving complete wound closure. •Time to complete wound closure •Sustainability of wound closure within the 12 week treatment time frame. •Course of wound closure over time. •Improvement of subjective symptoms (itching, pain, well-being using Visual Analogue Scores (VAS)) •Improvement of objective clinical symptoms (prickling, heat sensation, cold sensation, numbness, furry feeling, smell, exudation) ;Primary end point(s): Relative wound area reduction (percentage change between last visit 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.;Timepoint(s) of evaluation of this end point: Weekly | — |
Countries
Estonia, Georgia, Latvia, Ukraine
Contacts
Public ContactClinical Trials Information
DermaTools Biotech GmbH
Outcome results
None listed