Novel approach for early screening and prevention of foot complications in T2 Diabetes Mellitus at rural community level of coastal districts; Manipal Amputation Prevention Program among People Living with Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- For the primary objective, the training of healthcare professionals, outcomes include questionnaire.
研究概览
简要总结
This interventional study aims to reduce foot complications in people with type 2 diabetes mellitus living in rural coastal areas by focusing on early screening, prevention, and education. The objective of the study includes 1. training the health professionals in screening, identification, and management of diabetic foot complications 2. Screen individuals with diabetes for foot complications and provide customized insoles for abnormal plantar pressure with footwear prescriptions 3. Promote awareness about diabetes, its complications, prevention, and management among the general population and those at risk of developing diabetes.
• In this study, we will train health professionals to screen, identify, and manage diabetic foot complications and to educate patients and their caregivers. Training will cover diabetic foot care, footwear selection, and patient communication, supplemented by workshops, hands-on training, and screening forms.
• Awareness initiatives will be conducted in the community, utilizing pamphlets, booklets, and awareness camps about diabetes, its complications, and prevention strategies.
• A comprehensive screening procedure will assess neuropathic status (vibration perception threshold and monofilament testing), vascular status (pedal pulsation, ankle–brachial index, and thermometry using an IR thermometer), and musculoskeletal parameters (muscle strength and tightness).
• Those identified with foot complications will undergo plantar pressure assessments and digital foot scanning to customize insoles and footwear. These custom orthotics will be tailored to patient-specific pressure points and foot morphology to reduce the risk of foot ulcers and amputation.
A minimum of 100 healthcare professionals will be trained for the first objective, around 2,000 participants with type 2 diabetes mellitus will be recruited from rural coastal communities for diabetic foot screening, and a minimum of 10 awareness camps will be held. Statistical analyses will be performed using Jamovi software, presenting demographic data as mean and standard deviation and frequency analysis for descriptive statistics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 45.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria for healthcare professionals: 1.
- •Individuals who are doctors, nurses, public health professionals, physiotherapists, and ASHA workers 1.
- •Healthcare professionals of any age 1.
- •Individuals who are working in healthcare setups in Udupi district
- •Inclusion criteria for the general population: 2.
- •People of the Udupi district 2.
- •Individuals more than 45 years of age 2.
- •People with or without diabetes 3.
排除标准
- •Exclusion criteria for healthcare professionals: 1.
- •Healthcare professionals are not willing to participate due to inadequate availability 1.
- •Short-term visiting healthcare professionals from outside the Udupi district
- •Exclusion criteria for the general population: 2.
- •People from outside the Udupi district
- •Exclusion criteria for patients with type 2 diabetes mellitus: 3.
- •People with locomotory dysfunction 3.
- •Psychiatric dysfunction.
结局指标
主要结局
For the primary objective, the training of healthcare professionals, outcomes include questionnaire.
时间窗: The questionnaire will be administered prior to training session and post training session. | For screening, all outcome measures are conducted or used at one time point at baseline during screening.
For the secondary objective, the screening of type 2 diabetes mellitus patients, outcome measures will be used
时间窗: The questionnaire will be administered prior to training session and post training session. | For screening, all outcome measures are conducted or used at one time point at baseline during screening.
Neuropathic assessments:
时间窗: The questionnaire will be administered prior to training session and post training session. | For screening, all outcome measures are conducted or used at one time point at baseline during screening.
- Monofilament testing
时间窗: The questionnaire will be administered prior to training session and post training session. | For screening, all outcome measures are conducted or used at one time point at baseline during screening.
- Vibration perception threshold
时间窗: The questionnaire will be administered prior to training session and post training session. | For screening, all outcome measures are conducted or used at one time point at baseline during screening.
Vascular assessments:
时间窗: The questionnaire will be administered prior to training session and post training session. | For screening, all outcome measures are conducted or used at one time point at baseline during screening.
- Thermometry (using IR thermometer)
时间窗: The questionnaire will be administered prior to training session and post training session. | For screening, all outcome measures are conducted or used at one time point at baseline during screening.
- Ankle Brachial Index (ABI)
时间窗: The questionnaire will be administered prior to training session and post training session. | For screening, all outcome measures are conducted or used at one time point at baseline during screening.
Musculoskeletal assessment:
时间窗: The questionnaire will be administered prior to training session and post training session. | For screening, all outcome measures are conducted or used at one time point at baseline during screening.
- muscle strength
时间窗: The questionnaire will be administered prior to training session and post training session. | For screening, all outcome measures are conducted or used at one time point at baseline during screening.
- muscle tightness
时间窗: The questionnaire will be administered prior to training session and post training session. | For screening, all outcome measures are conducted or used at one time point at baseline during screening.
次要结局
- Plantar pressure assessment using the Harris mat(Footwear assessments)
研究者
Dr G Arun Maiya
Manipal College of Health Professions, MAHE Manipal