A Clinical Minute: Giving New Life to Complex Wounds – The Dynamics of AMNIOEXCEL® Amniotic Tissue Supported by the TCC-EZ® Healing Chamber™

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The ultimate goal in the management of diabetic foot ulcers (DFUs) is to prevent the “amputation stairway” of compounding steps from diabetes and neuropathy through to amputation. Total contact casting (TCC) is considered the cornerstone and gold standard in DFU management based on its proven efficacy.1-7

However, in many cases, effective offloading is just 1 piece of the puzzle. With a primary goal of rapid wound closure to reduce the risk of complications and improve outcomes, the use of advanced wound care modalities, such as cellular and/or tissue-based products (CTPs), also should be considered if wound area is not reduced by 50% after 4 weeks of conservative management.8,9 Using these modalities with TCC is crucial, because advanced therapies are unlikely to succeed without effective offloading.7

AMNIOEXCEL® (BioD, LLC made available by Derma Sciences, Inc, Princeton, NJ) is a dehydrated human amnion membrane. Its combination of properties provides a natural matrix for cellular attachment and assists in cell migration and proliferation.10 AMNIOEXCEL® is not side-specific and is processed via a proprietary DryFlex® process, making it easy to handle and conform to the wound bed upon application without the need for hydration.

AMNIOMATRIX® (BioD, LLC made available by Derma Sciences, Inc, Princeton, NJ) is a cryopreserved viable human placental suspension composed of morselized amnion membrane and components of amniotic fluid recovered from the same donor. AMNIOMATRIX® is processed through a patented (US Patent # 8,932,805) CryoPrime™ process to preserve the inherent extracellular matrix, growth factors, and cytokines.

At our wound care center, complex and challenging wounds are the norm; 80% of the patients have diabetes. We regularly use TCC-EZ® Total Contact Casting System (Derma Sciences, Inc, Princeton, NJ). The system creates a Healing Chamber™ that works on both the macro-environment and micro-environment of the wound. It allows for active healing by reducing pressure and shear within the cast and provides a safe environment that reduces inflammation and where granulation tissue can grow.11 For more difficult wounds or high-risk patients, TCC-EZ® is used with advanced wound therapies such as AMNIOEXCEL® and AMNIOMATRIX®.

 

Case Study

A 32-year-old man with type 1 diabetes presented to the ER with oozing from his right plantar foot for the past 24 hours. He had a history of chronic recurrent foot ulcers due to underlying biomechanical problems. He was previously treated with TCC and discharged with a prescription for custom-made orthotics and shoes that unfortunately, did not arrive in time to prevent recurrence. At the ER, wound area was 0.44 cm2 and volume 0.22 cm3.  He was treated with antibiotics and referred to our wound care clinic, where he was seen 14 days later. The wound bed was clean, granular, and healthy in appearance with no signs of infection, and X-ray further confirmed a low likelihood of osteomyelitis. Because his wound was a recurrent problem, we felt aggressive offloading and advanced wound therapies were needed.

AMNIOEXCEL® was applied (see Figure 1), followed by XTRASORB® Foam Dressing (Derma Sciences, Inc, Princeton, NJ) (see Figure 2). The patient then was fitted with TCC-EZ® (see Figure 3). At follow-up visits, he reported tolerating TCC-EZ® well. After 1 week, the wound improved and remained healthy in appearance (see Figure 4). After only 2 weeks (1 application of AMNIOEXCEL®), the wound closed (see Figure 5). He was discharged with custom inserts and shoes.

In summary, the use of AMNIOEXCEL® optimizes tissue growth while TCC-EZ® protects against sheering and pressure — together, they work in concert to achieve optimal healing outcomes. In our clinic, the use of this combination has helped our high-risk patients with complex DFUs achieve rapid wound closure, minimizing the risk for complications while improving patient quality of life.

Want to know more? Please visit www.dermasciences.com.

This article was not subject to the Ostomy Wound Management peer-review process.

References: 

1.  Armstrong DG, Nguyen HC, Lavery LA, van Schie CH, Boulton AJ, Harkless LB. Off-loading the diabetic foot wound. Diabetes Care. 2001;24(6):1019–1022.

2.  Armstrong DG, Lavery LA, Wu S, Boulton AJ. Evaluation of removable and irremovable cast walkers in the healing of diabetic foot wounds. Diabetes Care. 2005;28(3):551–554.

3.  Katz IA, Harlan A, Miranda-Palma B, Prieto-Sanchez L, Armstrong DG, Bowker JH, et al. A randomized trial of two irremovable off-loading devices in the management of plantar neuropathic diabetic foot ulcers. Diabetes Care. 2005;28(3):555–559.

4.  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 fiberglass cast. Diabetes Care. 2007;30(3):586–590.

5.  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; doi: 10.1111/iwj.12213.

6.  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.

7.  Snyder RJ, Frykberg RG, Rogers LC, Applewhite AJ, Bell D, Bohn G, et al. The management of diabetic foot ulcers through optimal off-loading. J Am Podiatr Med Assoc. 2014;104(6):555–567.

8.  Warriner RA, Snyder RJ, Cardinal MH. Differentiating diabetic foot ulcers that are unlikely to heal by 12 weeks following achieving 50% percent area reduction at 4 weeks. Int Wound J. 2011;8(6):632–637.

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.

10. Niknejad H, Peirovi H, Jorjani M, Ahmadiani A, Ghanavi J, Seifalian AM. Properties of the amniotic membrane for potential use in tissue engineering. Eur Cell Mater. 2008;15:88–99.

11. Piaggesi A, Viacava P, Rizzo L, Naccarato G, Baccetti F, Romanelli M, et al. Semiquantitative analysis of the histopathological features of the neuropathic foot ulcer. Diabetes Care. 2003;26(11):3123–3128.