Clinical Efficacy and Safety of a New Method for Pressure Off-load for Patients with Diabetic Foot Syndrome: Ankle-foot Pneumoorthosis with TM Orlett
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...
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| Format: | Article |
| Language: | English |
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Endocrinology Research Centre
2014-12-01
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| Series: | Сахарный диабет |
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| Online Access: | https://www.dia-endojournals.ru/jour/article/view/6587 |
| _version_ | 1797255220386856960 |
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| author | Galina Yur'evna Strakhova Sergey Valentinovich Gorokhov Irina Nikolaevna Ul'yanova Gagik Radikovich Galstyan |
| author_facet | Galina Yur'evna Strakhova Sergey Valentinovich Gorokhov Irina Nikolaevna Ul'yanova Gagik Radikovich Galstyan |
| author_sort | Galina Yur'evna Strakhova |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-08T15:21:28Z |
| format | Article |
| id | doaj.art-8c51d857060a419da046e65699c1ee8f |
| institution | Directory Open Access Journal |
| issn | 2072-0351 2072-0378 |
| language | English |
| last_indexed | 2024-04-24T22:02:23Z |
| publishDate | 2014-12-01 |
| publisher | Endocrinology Research Centre |
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| series | Сахарный диабет |
| spelling | doaj.art-8c51d857060a419da046e65699c1ee8f2024-03-20T11:47:59ZengEndocrinology Research CentreСахарный диабет2072-03512072-03782014-12-01174667110.14341/DM2014466-716528Clinical Efficacy and Safety of a New Method for Pressure Off-load for Patients with Diabetic Foot Syndrome: Ankle-foot Pneumoorthosis with TM OrlettGalina Yur'evna Strakhova0Sergey Valentinovich Gorokhov1Irina Nikolaevna Ul'yanova2Gagik Radikovich Galstyan3Endocrinology Research Centre, MoscowEndocrinology Research Centre, MoscowEndocrinology Research Centre, MoscowEndocrinology Research Centre, MoscowAim. 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.https://www.dia-endojournals.ru/jour/article/view/6587diabetes mellitusdiabetic footpedographypressure reliefankle-foot orthosis |
| spellingShingle | Galina Yur'evna Strakhova Sergey Valentinovich Gorokhov Irina Nikolaevna Ul'yanova Gagik Radikovich Galstyan Clinical Efficacy and Safety of a New Method for Pressure Off-load for Patients with Diabetic Foot Syndrome: Ankle-foot Pneumoorthosis with TM Orlett Сахарный диабет diabetes mellitus diabetic foot pedography pressure relief ankle-foot orthosis |
| title | Clinical Efficacy and Safety of a New Method for Pressure Off-load for Patients with Diabetic Foot Syndrome: Ankle-foot Pneumoorthosis with TM Orlett |
| title_full | Clinical Efficacy and Safety of a New Method for Pressure Off-load for Patients with Diabetic Foot Syndrome: Ankle-foot Pneumoorthosis with TM Orlett |
| title_fullStr | Clinical Efficacy and Safety of a New Method for Pressure Off-load for Patients with Diabetic Foot Syndrome: Ankle-foot Pneumoorthosis with TM Orlett |
| title_full_unstemmed | Clinical Efficacy and Safety of a New Method for Pressure Off-load for Patients with Diabetic Foot Syndrome: Ankle-foot Pneumoorthosis with TM Orlett |
| title_short | Clinical Efficacy and Safety of a New Method for Pressure Off-load for Patients with Diabetic Foot Syndrome: Ankle-foot Pneumoorthosis with TM Orlett |
| title_sort | clinical efficacy and safety of a new method for pressure off load for patients with diabetic foot syndrome ankle foot pneumoorthosis with tm orlett |
| topic | diabetes mellitus diabetic foot pedography pressure relief ankle-foot orthosis |
| url | https://www.dia-endojournals.ru/jour/article/view/6587 |
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