Aim. The purpose of this study was to assess the clinical efficacy, safety and consumer properties of ankle-foot pneumoorthosis with a HAS-337 TM Orlett compared with non-removable total contact cast (TCC) immobilization. Materials and methods. Our study included 40 patients with diabetes mellitus type 1 (DM1) and type 2 (DM2) with neuropathic diabetic foot syndrome and chronic uninfected wounds of the plantar surface of the forefoot, with wound duration of at least 3 weeks, wound areas not less than 1 cm2 and wound depths not more than stage II based on Wagner?s classification. We excluded patients with infected wounds, osteomyelitis, Charcot osteoarthropathy or peripheral vascular disease. Our test group included 20 patients who received pressure off-load using ankle-foot pneumoorthosis with a HAS-337 TM Orlett. For a control group (n = 20), pressure off-load was achieved using TCC immobilization. Both groups were comparable with regard to age, gender, duration and degree of diabetes compensation and by original wound defect sizes (p >0.05). The study duration was 6 months. Plantar pressure was measured inside the orthosis or TCC and was compared with test shoe measurements. Our major criteria for pressure relief were reduced pressures in the wound area and the whole foot and the rate of wound healing. Results. At the end of the 6-month period, complete healing of all ulcers was achieved. The average healing time was 46.1?19.0 days for the test group and was 48.3?20.5 days for the control group (p >0.05). Two patients who wore pneumoorthosis with HAS-337 were discontinued upon patient request. With pneumoorthosis, the maximum peak pressure on the foot and wound defect areas was reduced by 26% and 57%, respectively. The pressure/time integral decreased on average by 41% (p >0.05). Furthermore, in the midfoot area with pneumoorthosis, the maximum pressure increased by 48% and the pressure/time integral increased by 47%. Conclusions. Using pneumoorthosis with HAS-337 was an effective and safe method for pressure off-load, resulting in 100% healing of uninfected neuropathic ulcers of the plantar surface of the forefoot. However, pneumoorthosis with HAS-337 is not recommended for those patients with wound defects in the midfoot and heel areas.
Цель. Изучить степень разгрузки стопы в иммобилизирующей разгрузочной повязке (по технологии ?Total Contact Cast? (ТСС))и частоту других факторов, способных нарушать ответ трофической язвы на лечение с применением ТСС, и возможности ихустранения. Методы. У 30 пациентов с синдромом диабетической стопы, амбулаторно получавших лечение с помощью ТСС, была проведенакомпьютерная педография, а также общеклиническое обследование и регистрация активности ходьбы. Оценивалась степеньснижения давления в области язвы и по всей стопе, а также результаты лечения язвы. Результаты. По данным педографии, ТСС по сравнению с обычной обувью снижала пиковое давление (максимальное из всех зонстопы) на 20% (от -70% до +84%), давление в зоне язвы - на 55% (-100%; +359%). Аналогичные изменения получены для инте-грала давление-время?. Доля пациентов с пиковым давлением в зоне язвы 1c , доля курящих пациентов не различались достоверно между группами. Пиковое давлениев области язвы было недостоверно выше у больных с неэффективностью лечения (156 (19-365) против 82 (12-72) кПа, p>0.05). Заключение. ТСС - эффективный метод разгрузки, в условиях повседневной практики обеспечивающий заживление трофическихязв в 70% случаев. При острой фазе ДОАП с язвой в проекции смещающихся костных фрагментов ТСС неэффективен, и пациентаследует направлять для проведения корректирующей хирургии (с ушиванием раны и последующим ношением ТСС). Если язва неотвечает на лечение в ТСС, а ишемия и остеомиелит исключены, необходимо исключать критическую колонизацию раны (в т.ч.резистентной микрофлорой) и недостаточную разгрузку области язвы в ТСС.
Aim. To assess efficiency of orthopedic footwear for diabetic patients by in-shoe computed pedobarography. Materials and methods. The study included 20 women with type 1 or 2 diabetes mellitus, diabetic polyneuropathy and/or angiopathy combined with moderate foot deformity. In-shoe computed pedobarography (F-scan, Tekscan, USA) was used to study pressure distribution patterns in ordinary footwear identical for each patient (control) and in special shoes shaped to the foot of individual patients. Results. Median peak pressure in orthopedic footwear was reduced by 29% compared with control value. The number of patients with overloaded foot regions decreased from 75 to 35%, p=0,025. The change of integral load indices for clinically significant foot regions was estimated at -34% (-67% -17%) for pressure-time integral and -26% (-65% +7%) for force-time integral (p
Aim. To assess efficiency of orthopedic footwear for diabetic patients by in-shoe computed pedobarography. Materials and methods. The study included 20 women with type 1 or 2 diabetes mellitus, diabetic polyneuropathy and/or angiopathy combined withmoderate foot deformity. In-shoe computed pedobarography (F-scan, Tekscan, USA) was used to study pressure distribution patterns in ordinary footwearidentical for each patient (control) and in special shoes shaped to the foot of individual patients. Results. Median peak pressure in orthopedic footwear was reduced by 29% compared with control value. The number of patients with overloadedfoot regions decreased from 75 to 35%, p=0,025. The change of integral load indices for clinically significant foot regions was estimated at -34%(-67%; -17%) for pressure-time integral and -26% (-65%; +7%) for force-time integral (p