A Prospective, Randomized, Open Label, Add-On, Parallel Arm, In-Patient Comparison Phase II Study to Evaluate the Safety and Efficacy of Diperoxochloric Acid (DermaPro®) in Wounds with Impaired Healing due to Chronic Venous Insufficiency, Chronic Venous/Arterial Insufficiency or Diabetes - DermaPro® in Wounds with Impaired Healing (Phase II)

• Conditions: Wounds with Impaired Healing; MedDRA version: 9.1Level: LLTClassification code 10048037Term: Wound healing disturbance of; MedDRA version: 9.1Level: LLTClassification code 10047246Term: Venous stasis ulcer; MedDRA version: 9.1Level: LLTClassification code 10048036Term: Wound healing delayed; MedDRA version: 9.1Level: LLTClassification code 10012664Term: Diabetic foot ulcer

• Registration Number: EUCTR2007-007748-85-DE
• Lead Sponsor: DermaTools Biotech GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified