Expert Recommendations for Optimizing Outcomes ... - Wounds

Group Discussion
As with standard care of DFUs, patients treated with
Apligraf should continue to be followed up on a weekly
basis. Based on the available data and clinical experience,
dosing of Apligraf should be undertaken as follows (Figure
10): Initial Apligraf application (Apligraf #1) can be
followed by reapplication (Apligraf #2) 1 to 3 weeks later.
After an additional 1 to 3 weeks, Apligraf reapplication can
be considered again (Apligraf #3). Apligrafs #2 and #3 can
be applied even if healing is not progressing because the
trajectory of healing may not become evident during the
initial phase of therapy. However, if after 3 applications the
wound is not progressing, reevaluate the patient for factors
that may be interfering with healing, especially ischemia,
ulcer infection, osteomyelitis, inadequate off-loading, poor
nutritional status, and poor glycemic control. If these factors
are under control, the patient should be considered for
2 additional applications (Apligraf #4 and Apligraf #5) to
maintain the trajectory of healing. If these factors are not
under control, they should be addressed before proceeding
with additional applications. A maximum of 5 Apligraf applications
is considered one course of therapy. The goal of
treatment is complete closure of the DFU.
Suggested Readings
• Marston WA; Dermagraft Diabetic Foot Ulcer Study
Group. Risk factors associated with healing chronic diabetic
foot ulcers: the importance of hyperglycemia. Ostomy
Wound Manage. 2006;52(3):26-32.
• Apligraf [prescribing information]. Canton MA:
Organogenesis Inc; December 2010. n
2.5 Summary
The care of patients with a DFU requires careful attention to critical elements to optimize the potential for successful
treatment. Thorough assessment of the patient, especially vascular status and the presence of soft tissue and bone infection,
will lead to accurate staging of patients. Once peripheral arterial disease and infection have been either excluded or
addressed, vigilance in offloading is the most important aspect of standard care. Coupled with debridement and appropriate
dressing selection, conscientious weekly evaluation is recommended. Should a patient fail to improve by 4 weeks
of care, reassessment is warranted as is consideration of advanced therapy.
Three products have received FDA approval for the treatment of DFUs that have not responded to conventional therapy,
Apligraf, Dermagraft and Regranex. Apligraf, a bilayered living-cell-based product, is supported by two randomized
clinical trials showing benefit and effectiveness data demonstrating clinical utility. Optimally, wounds should be debrided
and fastidious offloading continued as serial applications every 1 to 3 weeks of Apligraf are applied. If the wound has not
responded after three applications, reassess factors that may be interfering with healing before proceeding with the two
additional applications.
Patients with DFUs are at risk for limb loss and death. The seriousness of this problem cannot be overstated and the
best results are achieved with a thorough evidenced-based process of care. n
20 Expert Recommendations for Optimizing Outcomes Utilizing Apligraf ® for Diabetic Foot Ulcers