E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic foot ulcers with mean diameter between 1.5 and 5 cm after débridement (if indicated); wound stage Wagner grade I or II, Armstrong stadium A or C (for Wagner-Armstrong-Classification), treated for at least 4 weeks unsuccessfully |
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E.1.1.1 | Medical condition in easily understood language |
Diabetic foot ulcers treated for at least 4 weeks unsuccessfully |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012664 |
E.1.2 | Term | Diabetic foot ulcer |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
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E.2.2 | Secondary objectives of the trial |
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.
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)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
- 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 |
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E.5 End points |
E.5.1 | 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). |
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E.5.1.1 | 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). |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |