- Volume 25 - Issue 10 - October 2012
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Valerie L. Schade, DPM, AACFAS, notes that approximately 10 percent of patients with diabetic foot osteomyelitis that she sees in practice require major amputations. The results of the study are fairly consistent with what she sees in her clinic.
“Antimicrobial therapy is an adjunctive treatment to surgical debridement,” explains Dr. Schade. “Overall, patients who present with peripheral vascular disease do not fare as well as patients who have adequate vascular supply and present with a diabetic foot ulceration and osteomyelitis.”
Dr. Schade notes the most effective strategies in limb salvage and/or limited amputation include:
• surgical removal of all infected and necrotic soft tissue and bone;
• wound bed preparation and/or final closure;
• a properly balanced limited amputation; and
• an emphasis on appropriate shoe gear and bracing.
“Final closure should consist of a procedure that maintains a functional limb that can be protected in appropriate shoe gear and/or bracing, reducing the potential for future complications,” explains Dr. Schade. “The final procedure often consists of some sort of amputation.”
If the podiatric surgeon takes care to ensure the foot is properly balanced via osseous or tendon balancing procedures, he or she can minimize the risk of future complications, adds Dr. Schade, the Chief of the Limb Preservation Service and Director of the Complex Lower Extremity Surgery and Research Fellowship at Madigan Healthcare System in Tacoma, Wash.
Could A New Cell Therapy Offer Potential For Venous Ulcers?
By Brian McCurdy, Senior Editor
A recent study in The Lancet concludes that a new cell therapy may have promise in treating venous leg ulcers.
The therapy in question, HP802-247, is a spray that contains growth-arrested allogeneic neonatal keratinocytes and fibroblasts. The phase 2 study focused on 205 patients, who were randomly assigned to receive 5.0×106 cells per mL every seven days or every 14 days; 0.5×106 cells per mL every seven days or every 14 days; or to the vehicle alone every seven days. As the study notes, there was a significantly greater mean reduction in wound area associated with active treatment as the dose of 0.5 ×106 cells/mL every 14 days demonstrated the biggest improvement in comparison with the vehicle. Furthermore, authors say adverse events were similar across all groups with only new skin ulcers and cellulitis occurring in more than 5 percent of patients.
As lead study author Robert Kirsner, MD, PhD, notes, HP802-247 is a first in class cell-based therapy that offers promise for better treatment of chronic venous ulcers.
“Existing tissue therapies Apligraf (Organogenesis) and Dermagraft (Advanced Biohealing) were engineered to look like skin. Since they don’t function as skin replacement but rather as a stimulus to healing, it raised the question of whether the cells, growth factors and cytokines could be delivered in another fashion,” notes Dr. Kirsner, a Professor, Vice Chairman and Stiefel Laboratories Chair in the Department of Dermatology and Cutaneous Surgery and the Chief of Dermatology at University of Miami Hospital at the University of Miami Miller School of Medicine.
The less intense regimen — fewer cells administered less frequently — proved most effective, notes Dr. Kirsner. As he points out, the Lancet study demonstrates the best results thus far for the treatment of refractory venous ulcers.
Dr. Kirsner notes the study reinforces physicians’ understanding that “more is not always better when it comes to stimulating cytokines and keratinocytes involved in the wound healing response.” He emphasizes that two phase 3 studies must be completed prior to FDA approval of the product.