A Multicentric, Double Blind, randomised, Comparative Phase III Study of the Efficacy of the new Wound Healing Solution Diperoxochloric acid (DPOCL, DermaPro®) compared to isotonic Sodium Chloride Solution 0.9% in Patients with Diabetic Foot Ulcers - DermaPro® versus isotonic sodium chloride solution in patients with diabetic foot ulcers

DermaTools Biotech GmbH0 个研究点目标入组 300 人开始时间: 2013年9月2日最近更新: 2016年3月14日

适应症

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•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

•- 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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