Utilization of a Comprehensive Protocol for Bioengineered Skin Substitutes in the Management of Diabetic Foot Ulcers in an Outpatient Wound Clinic Setting

Introduction:  Multiple studies have addressed the management of non-healing diabetic foot ulcers utilizing a multitude of advanced wound modalities including bioengineered skin substitutes.  It is clear that the products are beneficial for healing outcomes but they are also quite costly for patients and medical systems.  It is clear a system for identification of appropriate criteria for selection and utilization of bioengineered skin substitutes is needed.  While the local coverage determination documents from the fiscal intermediaries for each region document criteria for the products, there is little information in literature to guide clinicians in the right time and selection of products.  In our outpatient Wound Treatment Center, we developed a protocol for bioengineered skin substitutes to manage patients with venous and diabetic foot ulcers.

Objective: To evaluate the outcomes utilizing a protocol for bioengineered skin substitutes to manage diabetic foot ulcers in an outpatient setting.

 Methods:   Thirty patients with diabetic foot ulcers were evaluated in an outpatient wound clinic using a comprehensive protocol for bioengineered skin substitutes.  The protocol addressed circulation, infection, presence of granulation, offloading, and advanced wound care.   Bioengineered skin substitutes were not initiated until the protocol was completed and it was clear that the patient’s wound was a candidate for graft with the product.  Once the protocol was completed and all criteria were met, twenty four of the thirty patients were treated with bioengineered skin substitute applications.  

Results: Following treatment of twenty four patients with bioengineered skin substitute, all patients had reductions in wound size, with 16 of 24 patients wounds’ healed by the last application of product.  

 CONCLUSION:  There is potential for optimal cost effective healing outcomes utilizing a comprehensive protocol for bioengineered skin substitutes in the management of non-healing diabetic foot ulcers.