The study aims to investigate whether removable off-loading devices are as effective as total contact cast to promote healing of non-complicated plantar ulcers.
Removable off-loading devices versus total contact cast to promote healing of plantar ulcer in Leprosy: a non-inferiority, randomized control trial
Project coordination
Project summary
Ulcer on the sole of the foot is a serious complication of leprosy. This happens because touch and pain sensations are lost due to nerve damage. Ulcers are inevitable despite leprosy-affected persons education to protect their limbs while engaging in the routine activities and work. The prevalence of ulcer ranges from 20% to as high as 50% requiring frequent hospital visits and admissions. One in two admissions and over 50% of bed days are utilized for ulcer care in leprosy hospitals, draining the existing resources. The chronic nature of the ulcers, forces patient to make a trade-off between work and treatment. The affected individuals often continue to walk and work as they do not feel pain or discomfort and report to the hospital very late.
Ulcer care is almost always institutional-based and provided by the leprosy centres (nongovernment organization) often located far from patients’ home addresses. Total contact plaster has been the accepted as effective strategy to expedite healing of ulcers. This reduces the pressure on the ulcer(referred to as ‘off-loading’) facilitating healing. One needs a high level of skill to apply total contact cast and improper applications can lead to serious complications. Therefore, in this proposed non-inferiority randomized control trial, the researchers aim to compare an innovative removable off-loading device (with the imbedded excavated insole under wound area) to the regular total contact plaster cast in healing of ulcers. The new device is easier to customize by health care staff and patients can use it in their homes thus making it more acceptable and user-friendly.
Patients with non-complicated ulcer will be randomly allocated to either the intervention group (removable cast) or the control group (total contact cast). The ulcer dressing, self-care teaching and other clinical care will be similar in both the groups. Patients will be recruited from a two large leprosy referral centres in North and Eastern part of India. The study centres have sufficient expertise in ulcer care in leprosy.
The primary outcome of the study will be the number of patients with healed ulcer at 6 weeks from recruitment or complete closure of the ulcer whichever is earlier and the reduction in the ulcer surface area as assessed using the standard tool, as time to heal in days. Secondary outcomes include ability to perform daily activities independently with the device, user satisfaction with off-loading devices used and the quality of life at 6 months from the recruitment. The study will provide evidence of the effectiveness of using removable casts for patients with non-complicated ulcers.
Co-financer: St. Francis’ Leprosy Guild