Wounds with Impaired Healing MedDRA version: 9.1 Level: LLT Classification code 10048037 Term: Wound healing disturbance of MedDRA version: 9.1 Level: LLT Classification code 10048036 Term: Wound healing delayed MedDRA version: 9.1 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer MedDRA version: 9.1 Level: LLT Classification code 10047246 Term: Venous stasis ulcer
Conditions
Interventions
Product Name: DermaPro®
Pharmaceutical Form: Concentrate for cutaneous solution
Other descriptive name: diperoxochloric acid
Concentration unit: mmol/l millimole(s)/litre
Concentration type: equal
Con
Sponsors
DermaTools Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •At least 2 wounds (ulcers) of one of the following types: - venous leg ulcer - mixed (venous/arterial) leg ulcer - diabetic foot ulcer Other wounds with impaired healing, e.g. decubitus ulcer, pure arterial 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. •Adequate perfusion of lower leg as determined by the ankle brachial pressure index (>0.5), or by a more precise method (e.g. TcPO2 > 30 mmHg, pelvic/leg angiography) if considered appropriate or necessary by the examining physician to exclude patients who require a revascularization therapy •Presence of the 2 target wounds for 1 month to 3 years without signs of healing •Area of the 2 target wounds between 1 cm2 and 40 cm2 (as measured in mm by multiplying greatest length by greatest width) after debridement (if appropriate) •Wound grade 1 or 2 (according to the Wagner classification) of the 2 target wounds •Presence of at least one of the following underlying diseases confirmed in anamnesis: - chronic venous insufficiency - chronic venous/arterial insufficiency - diabetes •Stationary or ambulant male or postmenopausal female patient between 50 and 85 years of age •General health condition consistent with study requirements as confirmed by anamnesis and physical examination •Written informed consent by the patient for study participation prior to protocol specific procedures 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
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 wounds •Peripheral arterial occlusive disease in the pelvic region or lower extremities •Vascular reconstruction or angioplasty less than 3 months ago or planned revascularization procedure •Inability or unwillingness to be fitted with appropriate shoe gear or an off-loading device (if required) •Clinically significant abnormal laboratory values except those typical for the underlying diseases mentioned in the inclusion criteria •Severe or uncontrolled heart disease •Renal failure or treatment with dialysis •Severe hepatic disease •Premenopausal female •Concurrent illness or a condition that may interfere with wound healing other those mentioned in the inclusion criteria (e. g. carcinoma, hematological 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 (prednisolone until a maximum dose of 7.5 mg daily is accepted) •Severe psychiatric or neurological disorder •Incapability of giving informed legal consent •Co-worker, student, relative or spouse of the investigator •Participation in the study already before •Participation in another experimental clinical trial during the previous 30 days prior to the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To verify the safety and efficacy of DermaPro® in wounds with impaired healing. Safety is determined by recording local and systemic adverse events as well as by hematology, clinical chemistry and urinalysis. Efficacy is determined by an in-patient comparison of the percent change in area of the wound treated with standard therapy (moist wound dressing containing isotonic sodium chloride solution) plus DermaPro® with the percent change in area of the wound treated with standard therapy alone after 4 weeks of treatment. ;Secondary Objective: •To determine the rate of responding wounds after 4 weeks of treatment with DermaPro® in comparison to the rate of responding wounds treated with standard therapy alone •To determine the relative number of patients with complete wound closure after 12 weeks of treatment with DermaPro® •To determine the relapse rate within 12 weeks after complete wound closure •To determine the wound site pain reduction in the two treatment arms •To determine germ load reduction in the wounds •To determine the efficacy of DermaPro® (after 4 and 12 weeks of treatment) in different wounds regarding size, duration, grade/stage, underlying disease and other characteristics;Primary end point(s): •Primary safety endpoint: determination of adverse events occurring locally and systemically, hematology, clinical chemistry, urinalysis •Primary efficacy endpoint: percent reduction of wound area after 4 weeks of treatment | — |
Countries
Germany
Outcome results
None listed