A study to test the efficacy of a new wound healing solution (DermaPro®) in patients with diabetic foot ulcers

• Conditions: 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; MedDRA version: 14.1Level: LLTClassification code 10012664Term: Diabetic foot ulcerSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-005841-19-HU
• Lead Sponsor: DermaTools Biotech GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-02
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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

- 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

Study & Design

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