Method: Twenty-four patients were treated with collagen/ORC/silver and fifteen control patients were treated according to a standard treatment protocol. Wound area was measured weekly over a maximum of 14 weeks and outcome was determined by percentage reduction in wound area. Levels of inflammatory proteases and cytokines were measured in wound fluid samples collected at baseline and at Week 4.
Results: Levels of proteases and inflammatory cytokines were higher in non-healing wounds compared with healing wounds. There was a reduction in the level of inflammatory biomarkers after 4 weeks of treatment with collagen/ORC/silver. There was a significantly increased rate of wound healing in the collagen/ORC/silver group compared with the control group after 4 weeks of treatment (p=0.035), according to the Margolis Index. There were no withdrawals due to infection in the collagen/ORC/silver treatment group. In contrast, 33% of patients in the control group were forced to drop out of the study due to wound infection.
Conclusions: Treatment with collagen/ORC/silver can help to promote wound healing while protecting the wound from infection. This study provides evidence that non-healing wounds have high levels of inflammatory biomarkers and that collagen/ORC/silver reduces both elevated levels of inflammatory cytokines and proteases in these non-healing wounds.
In this study, treatment of diabetic foot ulcers with collagen/ORC/silver led to increased rates of healing and decreased incidence of infection.