The History. Larry A. Suecof, DPM, FACFAS, CWS Orthomerica Products, Inc. All Rights Reserved. SL00189 Rev. E

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1 The History Successful treatment of the diabetic foot ulcer depends on many medical variables. One thing that remains constant the pressure, trauma, or deformity that caused the wound must be corrected and relieved. hen the patient with Diabetic Peripheral Neuropathy exhibits gait deviations due to ankle instability, foot deformity or contracture, repeated micro trauma may cause ulceration to a particular part of the foot. Contractures of the achilles tendon can often lead to midfoot, forefoot, or digital ulcers. Likewise, ankle instability or a lax achilles tendon can contribute to heel ulceration in the insensate limb. Most diabetic ulcers are secondary to an orthopedic anomaly and neuropathic foot. Healing success and healing time depend on medical factors such as a patient s general health, controlled AC, vascular health, and weight, to mention just a few. Maximal correction and unloading of the anomaly is imperative for the fastest possible positive outcome. In 005, Jeff Miller C.O. began providing orthotic care to what became a large segment of the diabetic population in Hartford, Connecticut. The attending surgeon challenged his staff to develop an orthotic program that would complement the ongoing wound therapies and post-operative care correcting the orthopedic anomaly that caused the wounds. I have successfully incorporated the OLS program into my diabetic wound practice as a viable alternative to total contact casting in patients with plantar heel and forefoot ulcers. The custom orthoses reduce shear forces to the foot while stabilizing the foot and ankle complex and reducing pressure to the affected site. Larry A. Suecof, DPM, ACAS, CS THE OAL: To keep our patient population ambulatory while stabilizing the foot and ankle and supporting or correcting the limb to promote all of the health benefits associated with mobility. The OLS Program is a culmination of ten + years of clinical orthotic development accommodating diabetic ulcers classified agner -4 with custom orthoses while correcting and stabilizing the ankle complex. As a ound Center team member, Jeff had the opportunity to develop close professional relationships with the other team members including Podiatric, ascular, and Plastic Surgeons. Not only is wound care interesting and rewarding, it is an effective way to network your Practice! Orthotic care is a very important component of a comprehensive wound care/limb salvage program. Any questions or inquiries regarding any of the Custom Orthoses or our treatment plans can be directed to Jeff Miller C.O., Clinical Services Manager. (877) x07 06 Orthomerica Products, Inc. All Rights Reserved. SL0089 Rev. E

2 New! C arbon L aminate A lignment alker The inspiration in developing the CLA technology was to address the primary deficits presented by patients with Charcot foot syndrome, foot ulcerations and other orthopedic conditions of the foot and ankle. The CLA provides a triplanar alignment tool that increases stability while standing, and also provides a smooth heel compression and dynamic rocker action while walking. The clinician benefits by precisely and efficiently aligning the orthosis in the patient fitting room, without the time-consuming sole adjustments required on conventional designs. The CLA System triplanar design features Sagittal plane: Coronal plane: Up to 6 (plus or minus 3 each direction) tilt leg anterior / posterior Up to 6 (plus or minus 3 each direction) tilt leg medial / lateral Transverse plane: Unlimited adjustment of line of progression of the footplate with respect to the orthosis The CLA allows for progressive adjustments to accommodate the many variables of a patient s gait, all performed in the fitting room after walking assessments. The incremental adjustments of the CLA system provide the patient with a more normal and fluid gait, encourage more walking activities, and minimize gait deviations often seen with other orthoses. The advanced design and composite materials used in the CLA create a dynamic rocker. Early and late stance phases are fine-tuned to the unique characteristics of the patient, while mid-stance stability remains a primary focus. The unique composite technology addresses three key components of disrupted walking patterns:. Altering the impact forces during initial loading. Affecting the amount of time spent on the limb during walking 3. Improving balance by minimizing gait deviations The CLA is available as an upgrade to any OLS HO or shark-o design for patients up to 350 pounds. SL007 Rev. A

3 C arbon L aminate A lignment alker Adjustment uide Leg Anterior 3 Leg Lateral Neutral -3-0 D B 3 3 Leg Medial 3 B D E A C C A E H Z C C Z H Neutral 0 J Y 0 0 Y J L X K K S S K K X L - N M U N S - - S N U M N Leg Posterior -3 P P R T -3-3 T R P P Model numbers Size Left Right Maximum weight Men s shoe size (US) SM up to 00 lbs. up to 8½ MD up to 00 lbs. 90½ L up to 00 lbs. and over SM up to 50 lbs. up to 8½ MD up to 50 lbs. 90½ L up to 50 lbs. and over SM up to 300 lbs. up to 8½ MD up to 300 lbs. 90½ L up to 300 lbs. and over SM up to 350 lbs. up to 8½ MD up to 350 lbs. 90½ L up to 350 lbs. and over 07 All Rights Reserved US & International Patents Pending SL007 Rev. A

4 shark-o Charcot Orthosis Custom to Cast or Scan from all industry standard file formats. eatures: Liner made from ¼" aliplast foam. Outer shell constructed of polypropylene for maximum control of the foot and ankle complex. Molded copolymer anterior internal shell to limit shear forces and lock the leg in securely. Tri-laminated foot bed consisting of two densities EA and one layer of P-Cell to help protect the foot during treatment. Used for the prevention and management of pressure ulcers caused by ischemia, direct trauma and/or repetitive stress often found in persons with: Diabetes Mellitus Charcot deformity Decreased sensation and/or paralysis oot fractures The shark-o style CRO Orthosis is a viable design that makes fitting and follow-up of the Charcot foot easier and more effective. Its design features reduce orthosis weight and pressure to the plantar foot surface as compared to the traditional CRO. Patent pending design allows adjustable volume changes of the calf while leaving the foot at a set volume. This is achieved by overlapping the foot section, locking it in place while at the same time smoothly underlapping the calf area allowing the anterior shell to slide easily under the posterior. This transition is made possible by the notched wedge shaped trim cutout at the ankle/instep. The patient can easily adjust for daily calf volume (edema) changes with simple strap adjustments. 07 All Rights Reserved US & International Patents Pending SL00 Rev. C

5 HO Heel or orefoot Relief Custom to Cast or Scan from all industry standard file formats. eatures: Liner made from ¼ aliplast foam, outer shell constructed of polypropylene for maximum control of the foot and ankle complex. Molded anterior internal shell to limit shear forces and lock the leg in securely. Tri-laminated foot bed consisting of two densities EA and one layer of P-Cell to help protect the foot during treatment. The forefoot design may be constructed as a solid ankle or with articulated ankle and plantar-flexion stop in patients where ankle motion is desirable. Any orthopedic anomaly that requires stabilization or support for ambulation Used as a post-operative walking orthosis Post TAL Procedure agner -3 wounds where un-weighted ambulation is desired 07 All Rights Reserved US & International Patents Pending SL009 Rev.

6 HO Midfoot/alking AO Custom to Cast or Scan from all industry standard file formats. eatures: Liner made from ¼ aliplast foam. Outer shell constructed of polypropylene for maximum control of the foot and ankle complex. Molded anterior internal shell to limit shear forces and lock the leg in securely. Tri-laminated foot bed consisting of two densities EA and one layer of P-Cell to help protect the foot during treatment. The foot bed may be designed to provide wound relief at the midfoot or forefoot. An outer sole has a rocker at the forefoot to provide transition to toe off during ambulation. Distal plastic guard helps protect toes. Any orthopedic anomaly that requires stabilization or support for ambulation Relief for midfoot ulcer during ambulation Post-TAL with plantar ulcer Immediate post-op forefoot or midfoot amputation Post Charcot support and Rocker oot support Post-Calcanectomy 07 All Rights Reserved US & International Patents Pending SL009 Rev.

7 HO Chopart/Lisfranc Relief Custom to Cast or Scan from all industry standard file formats. eatures: Liner made from ¼ aliplast foam. Outer shell constructed of polypropylene for maximum control of the ankle and amputated site. Molded anterior internal shell to limit shear forces and lock the leg in securely. Trilaminated distal end pad with an extra 3/6 P-Cell cushions amputation site during ambulation. Immediate post Chopart or Lisfranc amputation Protection of amputation site during ambulation Delayed closure at amputation site Relief for ulcer/wound as a result of post Chopart or Lisfranc amputation 07 All Rights Reserved US & International Patents Pending SL0094 Rev.

8 ADO Advanced Diabetic Orthosis Custom to measurements. eatures: Inner lining made from soft foam to help protect the skin. Outer liner constructed of firm EA to maintain shape while accommodating volume changes of the leg. Rigid posterior shell constructed to allow full heel relief in every plane while maintaining the ankle angle at 90. The extended foot section extends beyond the toes to help protect the toes from ulceration. ADO has a non-skid sole to allow patients to ambulate short distances in the home. agner + ulceration of the heel. (Can be constructed to accommodate malleolus, leg, and forefoot wounds). Post-operative wound care. ADO easily accommodates a wound vac. Post-Calcanectomy 07 All Rights Reserved US & International Patents Pending SL0090 Rev.

9 EvenUp Shoe Balancer The EvenUp Shoe Balancer may be worn over existing footwear to level height of the contralateral limb. EATURES & BENEITS Two height adjustments:.0cm with layer or.cm with both layers our Universal (left or right) sizes to accommodate any foot, while reducing inventory. Size Model # omen s Size Men s Size SM ½ 6½ 8 MD ½ 8½ 0½ L ½ XL ½ All Rights Reserved US & International Patents Pending SL0093 Rev. E

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