TREAT Advanced Wound Care Giving New Life to Complex Wounds AmnioExcel ® Amniotic Allograft Membrane is a human placental-based tissue product processed using a proprietary method. The membrane acts as protective covering when placed over the wound, providing the key components found in human amnion including an intact extracellular matrix (ECM), growth factors, and cytokines. AmnioExcel easily molds and conforms to the wound, and helps provide an environment to repair, reconstruct, and replace tissue.
Transcript
TREAT
Advanced Wound Care
Giving New Life to Complex WoundsAmnioExcel® Amniotic Allograft Membrane is a human placental-based tissue product processed using a proprietary method. The membrane acts as protective covering when placed over the wound, providing the key components found in human amnion including an intact extracellular matrix (ECM), growth factors, and cytokines. AmnioExcel easily molds and conforms to the wound, and helps provide an environment to repair, reconstruct, and replace tissue.
membrane, compact and fibroblast layers of the amniotic tissue,
as illustrated in the histology section on the right.15 Other
histological assessments demonstrate the presence of collagen
and proteoglycans.
Retains key proteins of unprocessed human amniotic membraneLaboratory analyses and assays demonstrated that the presence of cytokines and growth factors were maintained with particularly high
quantities of EGF, PDGF, TGF-α, and TIMPs 1 and 2.15
Why Amniotic Tissue?
The science behind AmnioExcel®
Hematoxylin and Eosin (H&E) stained tissue demonstrating normal amnion architecture with intact epithelium, compact layer and fibroblast layer.
HISTOLOGY OF AMNIOEXCEL
(Magnified image of AmnioExcel Amniotic Allograft Membrane)
Amnion epithelial cells
Fibroblast layerCompact layer
Growth Factors Interleukins Tissue inhibitors of metalloproteases
A Prospective, Randomized, Multicenter and Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft (DAMA) compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcers.
Robert J. Snyder, DPM, MSc; Kenneth Shimozaki, DPM; Arthur Tallis, DPM; Michael Kerzner, DPM; Alexander Reyzelman, DPM;
Dimitrios Lintzeris, DO; Desmond Bell,DPM; Randi L. Rutan; and Barry Rosenblum, DPM
WOUNDS, March 2016
In this trial:
• Stratified randomization yielded a statistically balanced demographic and wound characteristic distribution between groups
• Endpoint of complete ulcer closure objectively adjudicated with photographs and ulcer tracings
• Comparable adverse event profile between groups
• Both the Intent To Treat (all randomized subjects) and the Per Protocol (all completing the study) populations demonstrated statistically
significantly greater ulcer closure rates with the addition of AmnioExcel® to the SOC regimen
Multicenter RCT demonstrates AmnioExcel® + Standard of Care (SOC) significantly increases closure of chronic Diabetic Foot Ulcers (DFUs)16
Clinicaltrials.gov #NCT02209051
Screening N=49
BaselineN=29
SOC* (n=14)Weekly dressing change
Study weeks with assessment by investigator
*SOC=Standard of Care including cleansing, debridement, moist dressing and off-loading‡ Per Protocol population
0Key Eligibility @ Baseline:
• HbA1c <12%• <30% decrease in ulcer area
Rand
omiz
atio
n
Endp
oint
: Com
plet
e cl
osur
e at
or
bef
ore
Wee
k 6
SOC +AmnioExcel® = 46%‡ closed
SOC = 0%
closed
-2 wkDebridement, measurement
2 weeksrun-in, SOC
SOC + AmnioExcel® (N=15)AmnioExcel® was applied every
1-2 weeks as determined by investigator. Weekly dressing changes.
0 1 2 3 4 5 6
This prospective, multicenter, randomized, controlled clinical trial (RCT) with standardized ulcer care and off-loading incorporated a 2
week run-in period. Despite a short 6-week study period, AmnioExcel® + SOC achieved significantly greater (p=0.008) ulcer closure rates
over SOC alone.
AmnioExcel® Membrane Case Studies
Diabetic Foot Ulcer with Vascular Insufficiency18
Patient History: 91 year old male with CVA, diabetes, ABI 0.49, DFU with exposed tendon following failed vascular intervention.
Challenges: Diabetes and vascular insufficiency.
Initial Assessment: Wound measured 1.2 x 1.2 x 0.7 cm (Figure 1). Patient was ambulatory with a brace.
Treatment Strategy: AmnioExcel® was applied every 2 weeks.
Wound Progress: Wound progressively decreased in size as new granulation tissue formed (Figure 2).
Outcome: The wound closed at week 6 following 2 applications of AmnioExcel® (Figure 3). As of week 9, the patient tolerated independent ambulation and resumed wearing diabetic footwear with inserts.
Case provided by Margaret Doucette, DO, FABPM, CWSPChief, Physical Medicine and Rehabilitation, Medical Director;Amputee/Wound Care/High Risk Foot, Boise VAMCBoise, ID
WOUND TYPE: DFU PRODUCTS USED/APPLICATIONS: AMNIOEXCEL® x 2 AND TCC-EZ® TIME TO CLOSE: 6 WEEKS
WEEK 0 INITIAL TREATMENT
WEEK 4 AFTER 2 APPLICATIONS
WEEK 6 WOUND CLOSURE AFTER 2 APPLICATIONS
Figure 1
Figure 2
Figure 3
Case 2
Post-Amputation Diabetic Foot Ulcer17
Patient History: 78-year-old male with diabetes, CAD, hyperlipidemia & HTN presented with post-amputation wound at his great left toe site measuring 4.0 x 3.3 x 0.6 cm.
Challenges: Diabetes and vascular insufficiency.
Initial Assessment: After 1 month of limited progress with standard wound care strategies and HBOT, he was treated with NPWT. Although he had previously been revascularized, his toe pressures had diminished to 25 mmHg, which is consistent with poor to lack of wound healing.
Treatment Strategy: Due to the slow rate of wound progression and failed therapies, AmnioExcel® Membrane was initiated at week 13 (Figure 1). AmnioExcel® Membrane was applied every 2 weeks with a total of 4 applications (Figure 2).
Wound Progress: Within 2 weeks, the wound was more granular (95%) and decreased in size.
Outcome: Wound closed 8 weeks after initial application of AmnioExcel® Membrane (Figure 3).
Case provided by Dimitrios Lintzeris, DO, CWS Medical Director, Wayne Memorial HospitalClinical Preceptor, Campbell University Jerry M. Wallace School of Osteopathic MedicineGoldsboro, NC
WOUND TYPE: DFU PRODUCTS USED/APPLICATIONS: AMNIOEXCEL® x 4 TIME TO CLOSE: 8 WEEKS
W E E K 0 I N I T I A L T R E AT M E N T
W E E K 2 A F T E R O N E A P P L I C AT I O N
W E E K 8 W O U N D C LO S U R E A F T E R 4 A P P L I C AT I O N S
Figure 1
Figure 2
Figure 3
Case 1
TREAT
AmnioExcel® Membrane Advantages
• Helps provide an environment to repair, reconstruct, and replace wound tissue
• AmnioExcel® is one of the only dehydrated amniotic allograft to have published, Level 1 clinical evidence supporting its use on DFUs16 and is supported by numerous peer-reviewed papers16,17,19-21
• DryFlex® Processing – Preserve the inherent ECM, growth factors, and cytokines
– Excellent handling and non-side specific application
– Molds and conforms upon application fully integrating into the wound over time
– Stored at room temperature with a 5 year shelf life
Indications For Use
AmnioExcel® Membrane is intended
for use in wounds. This placental-
derived allograft tissue is intended
for homologous use for the repair,
reconstruction and replacement of
skin at the discretion of a physician.
• Clinical Applications to Repair,
Reconstruct, and Replace for:
– Chronic and
acute wounds
– Diabetic ulcers
– Venous & arterial ulcers
– Pressure ulcers
– Traumatic injuries
– Burns
– Surgical wounds
FDA Regulation
AmnioExcel® Membrane
is regulated as a Human Cellular
and Tissue-Based Product (HCT/P)
under Section 361 of the Public
Health Service Act and is governed
by the FDA Center for Biologics
Evaluation and Research (CBER).
Dehydrated Amniotic Membrane Allograft (AmnioExcel®), in combination with SOC …is more likely to lead to complete wound closure, to accelerate the rate of wound closure and presents no additional safety risks when compared to SOC alone in the treatment of DFUs.1
References: 1. Davis JW. Skin Transplantation. Johns Hopkins Med J 1910;15:307–96. 2. Hao Y, Ma DH, Hwang DG, et al. Identification of antiangiogenic and anti-inflammatory proteins in human amniotic membrane. Cornea 2000;19(3):348–52. 3. Fetterolf DE, Snyder RJ. Scientific and clinical support for the use of dehydrated amniotic membrane in wound management. Wounds 2012(10):299–307. 4. Solomon A. Suppression of interleukin 1alpha and interleukin 1beta in human limbal epithelial cells cultured on the amniotic membrane stromal matrix. Br J Ophthalmol 2001;85(4):444–9. 5. Kim JS, Kim JC, Na BK, et al. Amniotic membrane patching promotes healing and inhibits proteinase activity on wound healing following acute corneal alkali burn. Exp Eye Res 2000;70(3):329–37. 6. Tseng SCG, Li D-Q, Ma X. Suppression of transforming growth factor-beta isoforms, TGF-ß receptor type II, and myofibroblast differentiation in cultured human corneal and limbal fibroblasts by amniotic membrane matrix. J Cell Physiol 1999;179(3):325–35. 7. Lee S-B, Li D-Q, Tan DT, et al. Suppression of TGF-ß signaling in both normal conjunctival fibroblasts and pterygial body fibroblasts by amniotic membrane. Curr Eye Res 2000;20(4):325–34. 8. Adzick NS, Longaker MT. Scarless fetal healing: Therapeutic implications. Ann Surg 1992;215(1):3–7. 9. Cuttle L, Nataatmadja M, Fraser JF, et al. Collagen in the scarless fetal skin wound: Detection with Picrosirius-polarization. Wound Repair Regen 2005;13(2):198–204. 10. Aagaard-Tillery KM, Silver R, Dalton J. Immunology of normal pregnancy. Semin Fetal Neonatal Med 2006;11(5):279–95. 11. Chen EH, Tofe AJ. A literature review of the safety and biocompatibility of amnion tissue. J Impl Adv Clin Dent 2010;2(3):67–75. 12. Bailo M, Soncini M, Vertua E, et al. Engraftment potential of human amnion and chorion cells derived from term placenta. Transplantation 2004;78(10):1439–48. 13. Liu J, Sheha H, Fu Y, et al. Update on amniotic membrane transplantation. Expert Rev Ophthalmol 2010;5(5):645–61. 14. Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev 2003;83(3):835–70. 15. Data on file. 16. Snyder RJ, et al, A Prospective, Randomized, Multicenter and Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcers, WOUNDS, 2016; 28(3):70-77. 17. Lintzeris D, et al, Use of Dehydrated Amniotic Membrane Allograft on Lower Extremity Ulcers in Patients with Challenging Wounds: A Retrospective Case Series. Ostomy Wound Management 2015; 61(10): 30-36. 18. Doucette M, Use of Dehydrated Amniotic Membrane Allograft to Facilitate Limb Salvage and Function in Patients at High Risk for Amputation. Nov. 2014, Clinical Poster, Phoenix AZ, USA, Poster. 19. Barr M. Dehydrated Amniotic Membrane Allograft for Treatment of Chronic Leg Ulcers in Patients with Multiple Comorbidities: A Case Series, JACCWS Feb, 2016. 20. Abdo R.J. Treatment of diabetic foot ulcers with dehydrated amniotic membrane allograft: a prospective case series, JWC Jul. 2016. 21. Rosenblum BI. A retrospective case series of a dehydrated amniotic membrane allograft for treatment of unresolved diabetic foot ulcers. J Am Podiatr Med Assoc 2016; 106(5):328-37.
AmnioExcel® Ordering Information
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