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

Phase 1

• 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: 17.1Level: LLTClassification code 10012664Term: Diabetic foot ulcerSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-17
• Last Update Posted: 8 August 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 (for ranges see laboratory manuals of the laboratories of the participating sites/ countries). These exceptions are at the discretion of the Investigator and taken into account in the tolerated ranges given in Section 15.5.1
- 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