This study tests the hypothesis that addition of a
protease-modulating matrix enhances the efficacy of autologous
growth factors in diabetic
ulcers. Fifty-one patients with chronic
diabetic foot ulcers were managed as outpatients at the Democritus University Hospital of Alexandroupolis and followed up for 8 weeks. All target
ulcers were > or = 2.5 cm in any one dimension and had been previously treated only with moist gauze. Patients were randomly allocated in three groups of 17 patients each: Group A was treated only with the oxidized
regenerated cellulose/
collagen biomaterial (Promogran, Johnson & Johnson, New Brunswick, NJ), Group B was treated only with autologous
growth factors delivered by Gravitational Platelet Separation System (GPS,
Biomet), and Group C was managed by a combination of both. All
ulcers were digitally photographed at initiation of the study and then at change of dressings once weekly. Computerized planimetry (Texas Health Science Center ImageTool, Version 3.0) was used to assess
ulcer dimensions that were analyzed for homogeneity and significance using the Statistical Package for Social Sciences, Version 13.0. Post hoc analysis revealed that there was significantly greater reduction of all three dimensions of the
ulcers in Group C compared to Groups A and B (all P<.001). Although reduction of
ulcer dimensions was greater in Group A than in Group B, these differences did not reach statistical significance. It is concluded that
protease-modulating dressings act synergistically with autologous
growth factors and enhance their efficacy in
diabetic foot ulcers.