Project coordination
The Leprosy Mission Trust India

Aim: The study aimed to investigate whether removable off-loading devices are as effective as total contact cast to promote healing of non-complicated plantar ulcers.

 Full project title:
Removable off-loading devices versus total contact cast to promote healing of plantar ulcer in Leprosy: a non-inferiority, randomized control trial

Final project summary:
One of the most common complications of leprosy is damage to the nerves in the feet, which can cause a loss of sensation. Without the ability to feel pain or pressure, people may unknowingly develop wounds on the soles of their feet, known as plantar ulcers. Because these wounds are often painless, individuals may continue walking on the affected area, causing further damage and making healing difficult.

A critical component of treating plantar ulcers is offloading—reducing the pressure placed on the wound to allow healing to occur. Alongside regular wound care and dressing, effective offloading is essential for preventing complications and promoting recovery.

For many years, the Total Contact Cast (TCC) has been considered the standard method for offloading plantar ulcers. While highly effective, the application of a TCC requires specialized training and expertise. However, the number of healthcare professionals skilled in applying the cast has declined, even within specialized leprosy hospitals. In addition, many patients find that wearing a cast limits their mobility and makes everyday activities more challenging.

To address these challenges, researchers explored the use of a Removable Walker Boot (RWB) as a simpler and more accessible alternative. Unlike the traditional cast, the walker boot is easier to apply, requires less specialized training, and may offer greater comfort and convenience for patients.

A randomized controlled study was conducted across three hospitals operated by The Leprosy Mission Trust India to compare the effectiveness of the two approaches. The study enrolled 151 people affected by leprosy who had simple plantar ulcers, assigning them randomly to receive treatment with either a removable walker boot or a total contact cast.

Of the participants enrolled, 128 completed the study, including 65 individuals in the walker boot group and 63 in the total contact cast group. Researchers assessed the proportion of ulcers that healed within six weeks, while also evaluating patient satisfaction and quality of life.

The findings showed encouraging results. Within six weeks, approximately 65% of ulcers in the walker boot group healed, compared with 73% in the total contact cast group. Although the cast group showed a slightly higher healing rate, the difference was small and did not clearly demonstrate that one treatment was superior to the other.

Importantly, participants using the removable walker boot reported higher levels of satisfaction with their treatment experience. Patients found the device easier to manage and more compatible with daily life. Furthermore, both groups experienced comparable improvements in quality of life over a six-month period, indicating that the walker boot was able to deliver similar longer-term benefits to the traditional cast.

The study provides important evidence that the removable walker boot can serve as an effective alternative to the total contact cast for the treatment of simple plantar ulcers in people affected by leprosy. By offering comparable healing outcomes while improving patient satisfaction and reducing dependence on highly specialized healthcare workers, the walker boot represents a practical and patient-friendly solution.

These findings are particularly significant for resource-limited settings, where access to trained staff may be limited. The removable walker boot has the potential to expand access to effective ulcer care, improve patient experiences, and contribute to better long-term outcomes for people living with the consequences of leprosy.