Evaluation of a Human Amniotic Membrane Allograft (AMNIOEXCEL ) for Treating Challenging Diabetic Lower Extremity Ulcers

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1 April 2014 Evaluation of a Human Amniotic Membrane Allograft (AMNIOEXCEL ) for Treating Challenging Diabetic Lower Extremity Ulcers Barry Rosenblum, DPM Associate Chief of Podiatry Beth Israel Deaconess Medical Center Assistant Clinical Professor of Surgery Harvard Medical School

2 Introduction: Lower extremity ulcers are a serious and significant complication for diabetic patients, leading to a drain on the overall cost of healthcare 1,2. The development of a better treatment strategy for these patients is critical to ensure the best outcomes, reduce or prevent amputations, and to minimize the burden on healthcare costs. The use of human amniotic membrane to treat a variety of wounds dates back nearly a century 3 but was limited in its use because of safety challenges and concerns with disease transmission. However, over the last several years, processes have been developed to clean and sterilize human amniotic membrane tissue yielding a room temperature-stable, safe tissue. 4 The natural human amniotic membrane is an attractive option for treating complex, chronic wounds because of its non-immunogenic 5, anti-inflammatory 6 and anti-bacterial 7 properties. The tissue also provides a matrix for cellular migration and proliferation and a number of essential growth factors and cytokines. 8 AMNIOEXCEL is a human amniotic membrane, donated from consenting women and retrieved at the time of child birth. This tissue is procured during cesarean section and the processing technology utilized maintains the extracellular matrix components and growth factors essential in the wound healing process. This paper provides an early look at the use of AMNIOEXCEL in complex, diabetic foot ulcers (DFUs). Methods: AMNIOEXCEL is available in a variety of sizes, provided dehydrated and stored at room temperature. Three patients were treated with a total of five wounds from February 2014 to April All wounds were prepared with sharp debridement to ready the wound bed for placement of the membrane. The AMNIOEXCEL was carefully removed from the sterile package with forceps and trimmed to size, if necessary, to overlap the wound margins by approximately 1mm. Once the membrane was placed into the wound, a moistened cotton swab was used to remove any air bubbles and ensure intimate contact with the wound bed. A non-adherent dressing was used to cover the membrane and was secured in place with retention tape. The wound was covered by a foam dressing which was used as a bolster to secure the membrane. All wounds were off-loaded.

3 Patient 1 Wound 1 36 year old female patient with poorly controlled Type I diabetes and a history of neuropathy and chronic ulcerations. Patient had significant bony deformities in the left foot secondary to Charcot arthropathy. thickness diabetic ulcer on the medial aspect of the left ankle. Week 2 Previous treatment consisted of standard wound care including debridement, exudate management and off-loading. After failing to progress with standard of care, Amnioexcel human amniotic membrane allograft was used on the wound. At the time of initial placement, week 0, the wound was approximately 5.8 cm 2. Patient received 3 applications of the amniotic membrane, placed once every two weeks. Week 3 Week 4 Wound improved dramatically and presented rapid progress demonstrated by contraction, granulation and decrease in size including depth. Full wound closure was achieved by week 6. Week 5 Week 6

4 Patient 1 Wound 2 36 year old female patient (same as previous). thickness diabetic ulcer on the plantar aspect of the left heel. Previous treatment consisted of standard wound care including debridement, exudate management and off-loading. After failing to progress with standard of care, Amnioexcel human amniotic membrane allograft was used on the wound. At the time of initial placement (week 0), the wound was approximately 1.0 cm 2. Patient received 2 applications of the amniotic membrane, one at week 0 and one at week 2. Week 1 Week 2 Wound improved dramatically and presented rapid progress demonstrated by contraction, granulation and a decrease in size, including depth, reaching full closure at 3 weeks. Week 3

5 Patient 2 Wound 1 67 year old female with a history of diabetes, neuropathy, chronic osteomyelitis and Charcot deformity of the left foot. thickness diabetic ulcer on the lateral aspect of the left ankle. Previous treatment consisted of standard wound care including debridement, drainage management and off-loading. After failing to progress with standard of care, Amnioexcel human amniotic membrane allograft was used on the wound. At the time of initial placement (week 0), the wound was approximately 3.6 cm 2. Patient received 2 applications of the amniotic membrane, placed at week 0 and week 2. Week 1 Week 3 Wound demonstrated contraction and granulation. By week 4, overall wound size and depth had improved dramatically. Week 4

6 Patient 3 Wound 1 69 year old male with a history of hypertension, diabetes, neuropathy, arterial insufficiency and chronic ulcerations on both feet. Four months prior to treatment with the membrane, patient underwent right lower extremity angioplasty and surgical debridement. One month prior, patient underwent right superficial femoral artery to dorsalis pedis bypass. thickness diabetic ulcer on the lateral edge of the right foot. Week 2 Previous treatment consisted of standard wound care including debridement, exudate management and off-loading. In addition, patient had been treated prior with negative pressure wound therapy (NPWT) and a living bi-layered skin substitute. After failing to progress with this treatment, Amnioexcel human amniotic membrane allograft was used on the wound. At the time of initial placement (week 0), the wound was approximately 2.6 cm 2. Patient received 3 applications of the amniotic membrane, placed once every two weeks. Week 5 Week 6 Wound presented rapid progress demonstrated by contraction, granulation and decrease in size. Wound closure was achieved by week 6.

7 Patient 3 Wound 2 69 year old male (same as previous). Four months prior to treatment with the membrane, patient underwent left lower extremity angioplasty. thickness diabetic ulcer on the lateral edge of the left foot. Previous treatment consisted of standard wound care including debridement, exudate management and off-loading. After failing to progress with standard of care, Amnioexcel human amniotic membrane allograft was used on the wound. At the time of initial placement (week 0), the wound was approximately 3.5 cm 2. Patient received 3 applications of the amniotic membrane, placed once every two weeks. Week 2 Week 5 Wound presented rapid progress demonstrated by contraction, granulation and decrease in size. Full wound closure was achieved by week 6. Week 6

8 Discussion Early results with the use of AMNIOEXCEL human amniotic membrane allograft are encouraging and suggest that incorporating this product into the wound care regimen for complex lower extremity DFUs can be beneficial. Controlled, prospective studies are needed to further analyze this technology however, these cases suggest that AMNIOEXCEL can be a viable option for treating recalcitrant DFUs. Barry Rosenblum, DPM serves as a paid consultant for Derma Sciences, Inc. References 1 Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, et al. Comprehensive foot examination and risk assessment: A report of the task force of the foot care interest group of the ADA, with endorsement by the AACE. Diabetes Care 2008; 8: Holzer SE, Camerota A, Marens L, et al. Costs and duration of care for lower extremity ulcers in patients with diabetes. Clin Ther 1998; 20: Davis JW. Skin transplantation with a review of 550 cases at the Johns Hopkins Hospital. Johns Hopkins Med J. 1910; 15: Zelen CM, Serena TE et al. A prospective randomized comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Int Wound J ISSN ; June: Ueta M, Kweon M-N, Sano Y, Sotozono C, et al. Immunosuppressive properties of human amniotic membrane for mixed lymphocyte reaction. Clin Exp Immun 2002; 129: Hao Y, Ma DH, Hwang DG, Kim WS, Zhang F. Identification of antiangiogenic and anti-inflammatory proteins in human amniotic membrane. Cornea 2000; 19: Kjaergaard N, Hein M, Hyttel L, Helmig RB, Schonheyder HC, Uldbjerg N, Madsen H. Antibacterial properties of human amnion and chorion in vitro. Eur J Obst Gyn & Reprod Bio 2001; 94: Parolini O, et al. Human term placenta as a therapeutic agent: from the first clinical applications to future perspectives. In: Berven E, editor. Human placenta: structure and development. Hauppauge, New York: Nova Science Publishers, 2012: CATAEWHITEPaPer AmnioExcel is registered trademark of of BioD, LLC

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