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Human Amniotic Membrane Allograft to Treat Diabetic Foot Ulcers with Exposed Bone and Tendon David Pougatsch, DPM; Karen Shum, DPM; Ronald Belczyk, DPM; Lee Rogers, DPM Amputation Prevention Center ® at Sherman Oaks Hospital – Los Angeles, CA Background Long-term effects of diabetes on the microcirculation and on dermal collagen eventually results in skin disorders in almost all diabetic patients. These skin disorders frequently result in full-thickness penetration of the dermis of the foot, infection and ulceration. Diabetic foot ulcers (DFU) are common complications in the diabetic population, resulting in significant associated morbidity and mortality. Diabetic foot ulcers can become infected and are life- and limb- threatening with approximately 8% of ulcers being resolved through amputation. 1 Human amniotic membrane allografts have been shown to be efficacious for the treatment of DFU. 2 Dehydrated Human Amnion/Chorion Membrane (dHACM) 3 Contains cytokines including anti-inflammatory interleukins (IL-1ra, IL- 4, IL-10) and the TIMPs (TIMP-1, TIMP-2, TIMP-4) which help regulate the matrix metalloproteinase (MMP). Contains one or more soluble factors capable of stimulating mesenchymal stem cell migration and recruitment. PURION ® processed dHACM has been shown to retain biological activities related to wound healing, including cell proliferation, inflammation, metalloproteinase activity, and recruitment of progenitor cells. Contains many growth factors that help in wound healing including PDGF-AA, PDGF-BB, bFGF, TGF-β1, EGF, VEGF, and PlGF. Methods Size it will be on the Poster Size of original Examples of Patients Treated with dHACM Purpose Our purpose is to evaluate the effectiveness of dHACM allograft (EpiFix ® , MiMedx Group Inc., Marietta, GA) in the treatment of 4 consecutive diabetic neuropathic patients who exhibited wounds with exposed bone and tendon. The intent of using the dHACM was to gain as much coverage over the exposed deep structures in as little time as possible in preparation for split-thickness skin grafting for permanent coverage. 4 consecutive diabetic neuropathic patients who exhibited wounds with exposed bone and tendon were treated with dHACM allograft. One lesion was considered Wagner grade 2, with the remaining three being Wagner grade 3 as they had documented osteomyelitis. All patients with osteomyelitis were being treated with appropriate intravenous antibiotics at the time of surgical intervention. Three ulcerations were gangrenous and had appropriate revascularization (endovascular and/or open bypass) by our vascular surgeon prior to treatment with the allograft, with the remaining patient’s ulceration being attributed to Charcot Neuroarthropathy secondary to trauma (motor vehicle accident). All patients had negative pressure wound therapy used as an adjunct to assist the allograft in adhering to the wound. Case 1. Human amniotic membrane allograft is useful as an adjunct in wound closure techniques in assisting the formation of granulation tissue in wounds with bone and tendon exposure in the diabetic neuropathic population. Conclusions Results EpiFix ® , PURION ® and MiMedx ® are registered trademarks of MiMedx Group, Inc. References 1. Jeffcoate WJ, Chipchase SY, Ince P, Game FL. Assessing the outcome of the management of diabetic foot ulcers using ulcer-related and person-related measures. Diabetes Care. 2006 Aug;29(8):1784-7. 2. Zelen CM, Serena TE, Denoziere G, Fetterolf DE. A Prospective randomized comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Int Wound J. 10(5):502-7. Oct 2013 3. Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J 2013 Oct;10(5):493-500. doi: 10.1111/iwj.12140. Epub 2013 Aug 1. *EpiFix ® - MiMedx Group Inc., Marietta, GA SAWC Spring Meeting, April 23-27, 2014 in Orlando, Florida Poster # CS 117 All 4 patients had sufficiently developed granulation tissue overlying bone and tendon structures and were ready for split-thickness skin grafting in an average of 15 days (range 9-22). 4 patients healed with split-thickness skin grafts and 3 patients returned to ambulating in custom diabetic shoes in 32 days (range: 27-36) after application of the allograft. One patient underwent below-knee amputation due to an unrelated circumstance. • 74 y/o male • Hx: DM2 w/neuropathy, PAD • s/p L 3 rd and 4 th toe amputation by local podiatrist, secondary to gangrene and osteomyelitis • Never had vascular surgery on board • Discharged from hospital and told to f/u with us • Underwent Popliteal-Dorsalis Pedis bypass grafting • 74 y/o female • Hx: smoking, DM2 w/neuropathy, PAD • s/p R foot bunionectomy and 2 nd toe PIPJ arthroplasty • Non-palpable DP/PT/AT/Per, 1+ Pop • Another surgeon performed resection and was packed open • 55 y/o male • Hx: DM2 w/neuropathy, Charcot • s/p MVA with open ankle dislocation • Treated with debridement, failed ORIF, subsequent casting • Presented 4 months after injury with foot just “hanging on” and collagen graft overlying • Osteomyelitis present in medial column and hindfoot • Underwent hindfoot and midfoot fusion with Ilizarov frame • 75 y/o male • Hx: DM2 w/neuropathy, ESRD on HD, PAD • Partial 2 nd ray amp performed 2 wks prior at another hospital secondary to gangrene and osteomyelitis • Referred to our center for workup • 1-vessel runoff (DP) on angiography • PTA of posterior tibial a. successful • TMA performed; we did not want to resect more bone just for purposes of closure Case 2. Case 3. Case 4. s/p popliteal-DP bypass graft dHACM placed into and overlying the wound Inquiries can be forwarded to primary author: [email protected] Case 1: From bypass, debridement and EpiFix ® to STSG = 14 days Case 2: From debridement and EpiFix ® to STSG = 16 days Case 3: From EpiFix ® to STSG = 22 days Case 4: From TMA and EpiFix ® to STSG = 9 days EP248.001
