A Clinical Minute: Using AMNIOEXCEL® Amniotic Tissue and the TCC-EZ® Healing Chamber™ to Heal a Diabetic Foot Ulcer
Healing diabetic foot ulcers (DFUs) becomes complicated due to the complex cascade of multisystem healing factors involved, including systemic factors such as vascularity and diabetes mellitus as well as local factors such as offloading and proper pH balance of the wound. However, this process can be made simpler with the use of TCC-EZ® Healing Chamber Total Contact Casting System (Derma Sciences Inc, Princeton, NJ) and cellular and/or tissue-based products such as AMNIOEXCEL® (a dehydrated human amniotic membrane from BioD, LLC, made available by Derma Sciences Inc, Princeton, NJ).
For the care of DFUs in our clinic, we follow the Wound Healing Society DFU Guidelines1 and conduct a VIP assessment, which includes vascular assessment, inspection for infection, and pressure relief. In addition, we ensure patients have adequate control of their diabetes and perform a nutritional assessment. Following assessment, we provide total contact casting (TCC), the gold standard for offloading2 based on clinical trials,3-8 which have demonstrated approximately 90% of wounds closed in as few as 33.5 days when offloaded utilizing a TCC system.
In complex cases, TCC may not be enough. Sheehan et al9 demonstrated wounds achieving <53% healing in a 4-week period have a minimal chance of healing with conventional therapy. This negative prognostic indicator has driven clinicians to progress to advanced therapy if adequate improvement is not seen at the 4-week mark. Although the addition of advanced modalities remains crucial, they are unlikely to improve wound healing outcomes unless combined with effective offloading.2
Therefore, at our Wound Care Center, TCC-EZ® is implemented as soon as possible; if the wound has not decreased in size sufficiently after 4 weeks, an advanced therapy such as AMNIOEXCEL® is added. Using this protocol of care, we have found an average of 2 to 3 applications of AMNIOEXCEL® helps facilitate wound closure when combined with TCC-EZ®, as illustrated in the following case.
A 50-year-old patient presented with a Wagner grade 3, full-thickness right lateral plantar ulcer, first assessed at our clinic on December 7, 2014. The patient had undergone a transmetatarsal amputation on September 7, 2014, which closed by primary closure. The wound was treated with hyperbaric oxygen and a variety of antibacterial and collagen wound care dressings and a bilayered bioengineered skin substitute with little or no change. TCC-EZ® was initiated in February; the wound showed slow progress. AMNIOEXCEL® was applied on March 26, 2015, at which point the wound measured 2 cm x 1.9 cm x 0.1 cm (see Figure 1). After 1 week, the wound measured 1.7 cm x 0.6 cm x 0.1 cm, a 73% decrease in area. AMNIOEXCEL® was applied weekly (3 applications) and TCC-EZ® was continued for 1 additional week until the wound closed at week 4 on April 21, 2015 (see Figure 2).
During our evaluation of AMNIOEXCEL®, we also assessed the costs associated with using this product. Our preliminary assessment suggested its use may lead to cost savings owing to a combination of faster healing rates with quicker discharge, the ability to use a smaller size product as the wound heals, and its cost as compared to competitive products. Our initial observations suggest further studies are warranted to assess the potential cost advantages of this product as part of a DFU protocol of care.
In conclusion, in our center, the use of TCC-EZ® provides forced compliance with offloading while allowing AMNIOEXCEL® to promote wound closure, simplifying the complexity of care of the DFU. In turn, our center has become better equipped to prevent the amputation stairway associated with DFUs.
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1. Steed DL, Attinger C, Colaizzi T, Crossland M, Franz M, Harkless L, et al. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen. 2006;14(6):680–692.
2. Snyder RJ, Frykberg RG, Rogers LC, Applewhite AJ, Bell D, Bohn G, et al. The management of diabetic foot ulcers through optimal off-loading: building consensus guidelines and practical recommendations to improve outcomes. J Am Podiatr Med Assoc. 2014;104(6):555–567.
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6. Piaggesi A, Macchiarini S, Rizzo L, Palumbo F, Tedeschi A, Nobili LA, et al. An off-the-shelf instant contact casting device for the management of diabetic foot ulcers: a randomized prospective trial versus traditional fibberglass cast. Diabetes Care. 2007;30(3):586–590.
7. Lavery AL, Higgins KR, La Fontaine J, Zamorano RG, Constantinides GP, Kim PJ. Randomised clinical trial to compare total contact casts, healing sandals and a shear-reducing removable boot to heal diabetic foot ulcers. Int Wound J. 2014 [epub ahead of print]. DOI: 10.1111/iwj.12213.
8. Mueller NJ, Diamond JE, Sinacore DR, Delitto A, Blair VP 3rd, Drury DA. Total contact casting in treatment of diabetic plantar ulcers. Controlled clinical trial. Diabetes Care. 1989;12(6):384–388.
9. Sheehan P, Jones P, Caselli A, Giurini JM, Veves A. Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial. Diabetes Care. 2003;26(6):1879–1882.
A Clinical Minute is made possible through the support of Derma Sciences, Inc, Princeton, NJ. The opinions and statements provided in A Clinical Minute are specific to the respective authors and not necessarily those of OWM or HMP Communications. This article was not subject to the Ostomy Wound Management peer-review process.