Pressure Alternating Shoes (PAS) for Prevention of Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded)
研究概览
简要总结
The project is designed to develop and test Pressure Alternating Shoes (PAS), which will periodically off-load certain regions of the foot in order to prevent foot ulcers. An automated dual layer insole compromised of an active pressurized actuator array in combination with a passive compliant layer on top of each actuator to modulate and distribute the plantar surface pressure as desired will be tested. This device will allow us to simultaneously load and offload select areas of the foot using the active layer by inflating and deflating individual actuators using pressurized air. After offloading, the remaining load will be distributed to other areas with inflated actuators. Automatic modulation will be provided through programmable control hardware which will cyclically relieve mechanical loading based on a prescribed duration and frequency.
详细描述
The two-tier human subjects study will be conducted to assess the biomechanical characteristics of PAS. In the first tier, we will test PAS in healthy subjects and in the second tier, we will test PAS in Diabetic Neuropathy patients (DN).
Subjects will walk on a treadmill in their usual daily shoes for 5 minutes, then with standard diabetic shoes with the PAS insoles for 5 minutes. Subjects will wear body worn sensors that assess position of the body. Subjects will have the temperature of their feet measured via a special camera after walking. Subjects will rest for 30 minute washout period and have the blood flow in the soles of the feet measured via a special camera. 1 healthy subject will undergo MRI of the foot and ankle.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or greater
- •Ability to wear insoles in shoes provided
- •Ability to walk unaided
排除标准
- •Diabetic Neuropathy
- •Charcot foot
- •Knee pain
- •Previous amputations
- •Inflammatory diseases such as rheumatoid arthritis
- •Open wounds, ulcers, sores or blisters on the feet; signs of infection in the feet
- •Diabetic population:
- •Age 18 or greater
- •Ability to wear insoles in shoes provided
- •Ability to walk unaided
- •Diagnosis of diabetic neuropathy
- •Excluision:
- •Charcot foot
- •Knee Pain
- •Previous amputations
- •Inflammatory diseases such as rheumatoid arthritis
- •Open wounds, ulcers, sores or blistesr on the feet; signs of infection in the feet
结局指标
主要结局
Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded)
时间窗: Before any cells were offloaded (First 40-seconds of the walk)
Maximum Average pressure values in the plantar regions before offloading during walking. The insole consists of seven air cells that align with specific regions: the big toe (cell 1), the area spanning from the second toe to the fifth toe (cell 2), metatarsal heads (cells 3 and 4), the midfoot (cells 5 and 6), and the heel (cell 7). Measurements were only obtained from the right foot.
Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device
时间窗: After offloading (approx. 41- 200 seconds walk)
Maximum Average pressure values in the plantar regions after offloading cells during walking. The insole consists of seven air cells that align with specific regions: the big toe (cell 1), the area spanning from the second toe to the fifth toe (cell 2), metatarsal heads (cells 3 and 4), the midfoot (cells 5 and 6), and the heel (cell 7). Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.
Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device
时间窗: Baseline (First 40-seconds of the walk)
Peak Interface Pressure values in the plantar regions before offloading during walking. The insole consists of seven air cells that align with specific regions: the big toe (cell 1), the area spanning from the second toe to the fifth toe (cell 2), metatarsal heads (cells 3 and 4), the midfoot (cells 5 and 6), and the heel (cell 7). Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.
Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device
时间窗: After offloading (approx. 41- 200 seconds walk)
Peak Interface Pressure values in the plantar regions after offloading during walking. The insole consists of seven air cells that align with specific regions: the big toe (cell 1), the area spanning from the second toe to the fifth toe (cell 2), metatarsal heads (cells 3 and 4), the midfoot (cells 5 and 6), and the heel (cell 7). Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.
Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device
时间窗: Baseline (first 40-second walk), 201 seconds after the intervention ended
Percentage change due to offloading for each participant is measured by dividing the pressure difference between the after offloading and before offloading values divided by the before offloading value. Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.
Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device
时间窗: Baseline (first 40-second walk), 201 seconds after the intervention ended
Peak pressure change due to offloading for each participant is measured by dividing the pressure difference between the peak after offloading and peak before offloading values divided by the peak before offloading value. Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.
次要结局
- Plantar Skin Temperature at Baseline, Right Foot(Baseline before the intervention (30 minutes after start of visit 1))
- Plantar Skin Temperature Post Intervention, Right Foot(Post intervention (215 seconds))
- Tissue Oxygenation (Oxygen Saturation) - for Plantar Lateral Foot(Post Gait (approx. 2015 seconds post intervention))
- Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot(Post Gait (approx. 2015 seconds post intervention))
- Tissue Oxygenation (Oxygen Saturation) - for Plantar Medial Foot(Post Gait (approx. 2015 seconds post intervention))
- Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial Foot(Post Gait (approx. 2015 seconds post intervention))
- Balance(Baseline)
研究者
Peter Crisologo, DPM
Professor
University of Texas Southwestern Medical Center