Diabetic foot ulcers with mean diameter between 1.5 and 5 cm after débridement (if indicated)
Conditions
Interventions
Product Name: DermaPro®
Product Code: DPOCL
Pharmaceutical Form: Concentrate for cutaneous solution
INN or Proposed INN: Diperoxochloric acid
Other descriptive name: Diperoxochloric acid
Concentration
Sponsors
DermaTools Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diabetic foot ulcer with mean diameter between 1.5 and 5 cm after débridement (if indicated) using the formula (longest length + longest width)/2. Wound shapes other than circular must have a both 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 for at least 4 weeks unsuccessfully 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. Diabetes mellitus with HbA1c = 12% and patient is under optimal control of blood glucose Adequate perfusion of the lower leg (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 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: - Local antibiotic therapy of the target wounds selected for the study - Suspicion of bone infection or osteomyelitis affecting the area of target wound - Peripheral arterial occlusive disease in the pelvic region or lower extremities - Vascular reconstruction or angioplasty less than 3 months ago or planned revascularization procedure - Start or change of a new off-loading strategy (already existing off-loading device is optimally applied and must be kept) - 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 in the tolerated ranges given in Section 15.5.1 - Severe or uncontrolled heart disease (NYHA class III or IV) - Renal failure or treatment with dialysis - Severe hepatic disease - 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) - Previous radiation of the region of the target wounds selected for the study - Exposure of any systemic immunosuppressive or cytostatic therapy during the previous 30 days prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of clinical efficacy of DermaPro® after administration into the unhealing, open diabetic wounds characterised the percentage of patients with wound closure (defined as the wound area entirely covered with connective tissue) and sustained wound closure 4 weeks after initial wound closure and cessation of treatment (i.e. healing rate);Secondary Objective: Time from onset of treatment until wound closure Percentage of patients with 50% reduction in baseline wound area after 4, 8 and 12 weeks of treatment. Percentage of patients with 90% or more wound closure at week 12 and cessation of study treatment, achieving wound closure after a further 4 weeks without study treatment. Safety characteristics of DermaPro® considering Adverse Events, (with particular highlighting of infectious adverse events), laboratory parameters and vital signs Characterisation of subjective symptoms using visual analogue scores (VAS) for pain, itching, and well-being Evaluation of subjective clinical symptoms (prickling, heat and cold sensation, numbness, furry feeling, smell, exudation) ;Primary end point(s): The primary objective of the study is to investigate, whether DPOCL (DermaPro®) shows clinical efficacy in comparison to a 0.9% physiological saline solution. The main criterion is the proportion of patients with wound closure (defined as the wound area entirely covered with connective tissue) and sustained wound closure 4 weeks after initial wound closure and cessation of treatment (i.e. healing rate).;Timepoint(s) of evaluation of this end point: Determination of time point of complete wound closure (time from start of treatment to entire closure of the wound, i.e. with wound closure defined as the wound area entirely covered with connective tissue and confirmed at study end (follow-up) visit). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The reduction at all time points has to be analysed. The relative reduction of wound area* (%) (= reduction / baseline *100) will be analysed. The influence of DPOCL treatment on the course of HbA1c will be investigated. Visual Analogue Scores (VAS) of pain, itching, and well-being. Subjective clinical symptoms (prickling, heat sensation, cold sensation, numbness, furry feeling, smell, exudation) will be evaluated descriptively. The relative frequency (%) of patients with an improvement, no change, or a deterioration of each symptom will be given. Additionally, a total symptom score shall be calculated as the sum of the subjective clinical symptoms (prickling, heat sensation, cold sensation, numbness, furry feeling, smell, exudation). Adverse Events (AE) will be listed and evaluated descriptively with regard to intensity, drug relationship, outcome, treatment, action taken and seriousness. AE incidence will be compared between the treatment groups using a two-sided Fischer Exact test. ;Timepoint(s) of evaluation of this end point: See above. | — |
Countries
Germany, Hungary, Latvia, Lithuania, Poland, Ukraine
Contacts
Public ContactDr. Dirk Kaiser
DermaTools Biotech GmbH
Outcome results
None listed