for healing of plantar ulcers due to leprosy and diabetes in the community

Comparison of removable off-loading device and routine care to heal plantar ulcers due to leprosy and diabetes in the community

Background

Plantar ulcers are a serious complication in leprosy and diabetes globally resulting in hospitalization, disability, and amputation. Continued pressure over the vulnerable site leads to ulcers and then impedes ulcer healing. Therefore, in addition to removal of infection off-loading the ulcer area is essential to heal the ulcer. The current proposed feasibility plus study is based on removable off-loading walker boot fitted with soft insole which can be easily applied with limited training and may allow the patient to continue their essential daily routine activities. We will test the feasibility and acceptability of using this device and set the scene for a potential trial to test the effectiveness of this device type in reducing ulcer development and ulcer complications in community setting.

Aim

To compare a removable pressure-relieving off-loading device with standard routine care for healing plantar ulcers due to leprosy and diabetes in the community.

Design

This is a community-based, randomized feasibility plus trial. The intervention will be a removable walker boot applied to off-load the ulcer area(s). The control group will have a standard care of micro-cellular rubber footwear.

Methodology

  • This is a feasibility study to assess the practicality of using a removable offloading device in community settings among 150 individuals with ulcers due to leprosy and/or diabetes.  
  • Participants in the intervention group will receive a removable walker boot with a custom insole designed to relive pressure on the ulcer area(s). The control group will receive standard microcellular rubber footwear as part of their care 

Current status

The study has been registered in CTRI. Currently, study is enrolling participants in India and Nepal.

Lead

  • Dr Joydeepa Darlong 
  • Dr Indra Bahadur Napit

Related People

  • Abhinav Bassi 
  • Samriddhi Ranjan 
  • Prashant Kharat

Partners

  • The George Institute for Global Health, India 
  • University of Birmingham 
  • The Leprosy Mission Trust India 
  • The Leprosy Mission Nepal 

Funders 

UK National Institute for Health Research (NIHR) and Innovation for Global Health Transformation (RIGHT) Programme

Related resources

Further reading