On World Lymphedema Day, it is important to remember that millions of people worldwide suffer from preventable lymphedema, caused by a parasitic infection called lymphatic filariasis. The clinical trial described here is an effort to provide relief for those who have been left behind in the fight against this neglected tropical disease.
The Neglected Tropical Diseases Support Center, along with the United States Agency for International Development (USAID) and research partners, is pleased to announce the launch of the ‘LeDoxy’ Clinical Trial in India, Mali, and Sri Lanka. The aim of this placebo-controlled trial is to assess the efficacy of the antibiotic doxycycline against the chronic and acute symptoms associated with lymphedema.
More than 15 million people worldwide suffer from lymphedema as a result of the parasitic infection lymphatic filariasis, according to the World Health Organization. Lymphedema of the leg or arm and its advanced form, known as elephantiasis, are significant causes of disability and morbidity in 72 countries endemic for lymphatic filariasis, which is transmitted by mosquitoes.
This condition is painful, debilitating, and stigmatizing, and people who suffer from this type of lymphedema are also prone to acute bouts of serious infection as a result. Both the acute and chronic symptoms can prevent individuals from working and carrying on with their daily life.
“Although mass treatment with antiparasitic drugs has led to significant reductions in the transmission of lymphatic filariasis worldwide, activities to address morbidity have lagged behind,” said Eric Ottesen, director of the Neglected Tropical Diseases Support Center. “Consequently, even countries that have successfully interrupted lymphatic filariasis transmission may have sizeable populations who continue to suffer from the disabling and stigmatizing effects of lymphedema.”
“The physical, social, and psychological suffering caused by lymphatic filariasis is enormous,” said Charles Mackenzie, Senior Technical Advisor to the Neglected Tropical Diseases Support Center. “This trial offers not only a potential treatment, but techniques to ensure a better quality of life – which those with lymphedema greatly deserve.”
The clinical trial, funded by a grant from USAID and managed by the Neglected Tropical Diseases Support Center, assesses the efficacy of a six-week course of doxycycline in hundreds of patients with progressive lymphedema. The researchers will evaluate the patients over the course of 2 years, measuring their legs using multiple techniques: basic tape measurements, photography, ultrasound, and an innovative new tool called Lymphatech for measuring limb volume. All study participants will also receive both training in proper hygiene, including education about the importance of washing the affected limbs daily with soap and water, and hygiene kits to help prevent acute symptoms.
Each site of the trial is being conducted in an area where lymphedema is prevalent, led by senior research partners:
- India: Government TD Medical College Hospital (Principal Investigator: Dr. Suma Krishnasastry)
- Mali: International Center for Excellence in Research (ICER) – Mali and U.S. National Institutes of Health (Principal Investigator: Dr. Yaya Coulibaly)
- Sri Lanka: University of Ruhuna and Washington University in St. Louis (Principal Investigator: Dr. Channa Yahathugoda)
This USAID-funded trial is coordinated with similar studies (known as TAKeOFF) being undertaken in Cameroon, Ghana, and Tanzania, with sponsorship by the German government and management by the University of Bonn.
The LeDoxy trial is scheduled to be completed by 2021.
For media inquiries, please contact:
Associate Director, Communications & Development
Neglected Tropical Diseases Support Center
+1 404 592 1466