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临床试验/NCT04795271
NCT04795271Enrolling By Invitation不适用

Biomechanical Study of Patients With Diabetic Foot for the Establishment of a Preventive Orthopedic Treatment Protocol for Major Complications

University of Valencia2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
2
主要终点
Change in the maximum plantar pressure (kPa)

研究概览

简要总结

Spain is the country with the second-highest rate of population amputation due to the development of ulcers, behind the United States, where 2 out of 3 non-traumatic amputations derive from diabetes. This is why the main objective of this project is to establish a study protocol for alterations in plantar pressures and gait abnormalities in diabetic patients, parallel to the preventive orthopedic treatment of major complications such as Charcot's foot, ulcers in the plantar support surface, and amputations. The study methodology will be based on the evaluation prior to the personalized orthopedic treatment for each patient and the evaluation after the orthopedic treatment, specifically at one week, one month, three months, and six months after the treatment. At each evaluation time, plantar pressure and reaction forces during walking and local infrared thermography will be analyzed. In the basal and final evaluation at six months, the muscular strength and range of motion of the lower limbs will also be evaluated. The orthopedic intervention is personalized to the requirements of the patients and is based on the use of an insole with the possible inclusion of orthopedic footwear in order to reduce plantar pressure.

详细描述

Background

Diabetic foot is the syndrome characterized by tissue changes (skin, joint, and/or bone) of the feet of diabetic patients as a result of peripheral neuropathy induced by high glucose levels, which can be aggravated by the coexistence of microcirculation alterations blood and whose production involves micro-traumas as a result of support during walking. When tissue repair or regeneration mechanisms are not effective, these initial lesions can evolve into ulcerations, superficial and/or deep infections, osteomyelitis or dislocations of the foot joints (Charcot's foot), with serious consequences for the patient such as limb amputation, whose costs for Public Health are high. It should be taken into account that Spain is the country with the second-highest rate of population amputation due to the development of ulcers, behind the United States, where 2 out of 3 non-traumatic amputations derive from diabetes.

This is why the main objective of this project is to establish a study protocol for alterations in plantar pressures and gait abnormalities in diabetic patients, parallel to the preventive orthopedic treatment of major complications such as Charcot's foot, ulcers in the plantar support surface, and amputations.

As specific objectives proposed are the following:

  1. To evaluate and objectify the clinical and biomechanical alterations of people with Diabetic foot before orthopedic treatment.
  2. To analyze the effects of immediate orthopedic treatment in the medium and long term in people with Diabetic foot through biomechanical and clinical parameters.
  3. To determine if the biomechanical analysis influences the decisions of the trauma doctors and rehabilitators treating the study participants.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with diabetic polyneuropathy
  • Metatarsalgia with hyperkeratosis and/or claw fingers with diabetic polyneuropathy
  • Support abnormalities in the coronal plane (supination/pronation)
  • Plantar ulcers secondary to alterations in evolving and healed plantar pressures
  • Charcot foot postoperative

排除标准

  • Peripheral arterial disease (absence of distal pulses or ischemia)
  • Active osteomyelitis
  • Patients with prostheses after amputation
  • Patients who travel mainly in a wheelchair due to gait abnormalities associated with other diseases.

结局指标

主要结局

Change in the maximum plantar pressure (kPa)

时间窗: 6 months

Maximum plantar pressure (kPa) detected in the baseline measurement and after 6 months of the use of orthopedic treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Constanza San Martín

Researcher

University of Valencia

研究点 (2)

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