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An Open, Randomised, Explorative, Phase II, Investigation Comparing Enamel Matrix Derivative Proteins (EMD) and Control In Patients With Pressure Ulcer Stage II
Author(s) -
Dierick AM.,
Van De Looverbosch Dirk,
Heyman Hilde,
Van De Looverbosch Dieter
Publication year - 2004
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/j.1067-1927.2004.0abstractct.x
Subject(s) - medicine , enamel matrix derivative , eosin , surgery , dentistry , pathology , staining , regeneration (biology) , biology , microbiology and biotechnology
Background : Enamel Matrix Derivative proteins (EMD) have been used as local adjunct to periodontal surgery in more than 600.000 patients. EMD is approved in Europe, USA and Japan as a medical device class III. There have been no negative reports concerning the safety of the EMD. This is the first reported controlled investigation in a series of ongoing investigations on EMD application in chronic wounds and burns. Aim of the study : The investigation was designed as an open randomised investigation with EMD (30 mg/ml) or vehicle control that consists of propylene glycol alginate (PGA) only. Ten patients were planned to be included. Male or female patients were >18 years of age and had had pressure ulcer present for more than 1 month. Patients with controlled diabetes were also included in the study. Patients with sacral pressure ulcer were to be excluded. EMD or vehicle control was applied weekly for up to 8 weeks. All patients received a secondary dressing (Mepilex ® Border). Ulcer status and area were measured at week 0, 2, 4, 6, and 8. The primary objective was to measure the wound area and the percentage of viable/non‐viable tissue. The secondary objectives were to evaluate ulcer tissue in biopsies taken before application (baseline) and at last visit. Tissue morphology was evaluated on haematoxylin‐eosin‐stained sections and the presence of EMD, selected growth factors, proliferating cells and myofibroblasts in tissue sections stained with monoclonal antibodies. Regulatory authority and Ethical committee in Belgium approved the investigation. Results : At the time of the abstract submission, results are not final. The histology and immunohistochemical evaluations will be performed November/December 2003.