Abstract
Background
More than three million persons are disabled by leprosy worldwide. The main complication of sensory nerve damage is neuropathic ulceration, particularly of the feet. In this review we explored interventions that can prevent and treat secondary damage to skin and limbs.
Objectives
To assess the effects of self-care, dressings and footwear in preventing and healing secondary damage to the skin in persons affected by leprosy.
Search methods
We searched the Cochrane Skin Group Specialised Register (April 2008), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2008), MEDLINE (from 2003 to April 2008), EMBASE (from 2005 to April 2008), CINAHL (1982-2006) and LILACS (1982- April 2008 ) as well as online registers of ongoing trials (April 2008).
Selection criteria
Randomised controlled trials involving anyone with leprosy and damage to peripheral nerves treated with any measures designed to prevent damage with the aim of healing existing ulcers and preventing development of new ulcers.
Data collection and analysis
Two authors assessed trial quality and extracted data.
Main results
Eight trials with a total of 557 participants were included. The quality of the trials was generally poor. The interventions and outcome measures were diverse. Although three studies that compared zinc tape to more traditional dressings found some benefit, none of these showed a statistically significant effect. One trial indicated that topical ketanserin had a better effect on wound healing than clioquinol cream or zinc paste, RR was 6.00 (95% CI 1.45 to 24.75). We did not combine the results of the two studies that compared topical phenytoin to saline dressing, but both studies found statistically significant effects in favour of phenytoin for healing of ulcer (SMD -2.34; 95% CI -3.30 to -1.39; and SMD -0.79; 95% CI -1.20 to 0.39). Canvas shoes were not much better than PVC-boots, and double rocker shoes did not promote healing much more than below-knee plasters.
Authors’ conclusions
One study suggested that topical ketanserin is more effective than clioquinol cream or zinc paste. Topical phenytoin (two studies) may be more effective than saline dressing regarding ulcer healing. For the other dressings the results were equivocal. Canvas shoes were a little better than PVC-boots, but not significantly, and the effect of double rocker shoes compared to below-knee plasters was no different in promoting the healing of ulcers. No side effects were documented.
There is a lack of high quality research in the field of ulcer prevention and treatment in leprosy. New trials should follow the current standards for design and reporting of randomised controlled trials.
Plain language summary
Interventions for skin changes caused by nerve damage in leprosy
Three million persons are affected by nerve damage caused by leprosy (Hansen’s disease) worldwide. Leprosy is a chronic infectious disease caused by the bacterium Mycobacterium leprae. About 30% of people with leprosy develop nerve damage that can lead to loss of normal sensation and skin damage. The skin can crack and become infected and ulcerated. Impairment of the affected limb, caused by nerve damage, can result in severe joint deformity and injuries. The major areas affected by sensory loss are the hands (especially the palms), feet (especially the soles) and eyes. The drug therapy offered to those with leprosy is efficacious and has low relapse rates. However, even with treatment, many with leprosy will go on to develop secondary damage to skin and limbs as the nerve damage sustained cannot be reversed. In some, treatment leads to inflammatory reactions in the nerves, sometimes resulting in further damage.
Many interventions may help the healing of such ulcers. The rationale behind the use of, for example, appropriate footwear is to protect feet from damage that can lead to superficial sores on the soles of the feet, and later ulcers and secondary infections. Self-care includes daily management to reduce the effects of nerve function impairment. Education, information and empowerment of those affected by leprosy (and their carers) is part of some leprosy programmes and might prevent ulcers developing. Dressings might enhance the healing of ulcers.
We included eight trials with a total of 557 participants. Based on weak evidence we suggest that dressings with topical ketanserin may be more effective than clioquinol cream or zinc paste and topical phenytoin may be more effective than saline dressings regarding ulcer healing. Canvas shoes seem to be a little better than PVC-boots, but not significantly. Double rocker shoes do not show statistically significant benefit compared to below-knee plaster in promoting healing of ulcers. Whether the interventions reduce social stigma and lead to better quality of life were not investigated in any of the eight trials in this review. No side effects were documented.
There is a lack of high quality research in the field of ulcer prevention and treatment in leprosy. New trials should follow the current standards for design and reporting of randomised controlled trials.
