This condition is caused by uncontrolled cell growth and division that damages tissue. The hallmark symptoms of Ledderhose disease are the tough nodules that form on the soles of the feet. Can poor sleep impact your weight loss goals? Men are affected more often than women. Imagine that your body is a castle and your immune system is your army fighting off invaders like bacteria. Participants with a disease may participate to help others, but also to possibly receive the newest treatment and additional care from clinical study staff. A headache that starts suddenly and feels like the worst headache youve ever had.. (2017). National Institute of Arthritis and Musculoskeletal and Skin Diseases. We link primary sources including studies, scientific references, and statistics within each article and also list them in the resources section at the bottom of our articles. Ankylosing spondylitis is an autoimmune arthritis. BOTTOM LINE: A positive ANA blood test may indicate an autoimmune disease. Have you had to go to the emergency department because of your symptoms? This condition may not cause symptoms in the early stages. Type 1 diabetes damages the pancreas. Treatment will depend on the underlying cause. (2012). It may occur at any age, with the greatest prevalence at middle age and beyond. Learn possible symptoms and how its diagnosed. Treatment is for correction of deformity from Dupuytren contracture. Reference: Data from the Newborn Screening Codingand Terminology Guide is available here. 2018 Dec 17;11:1-7. doi: 10.2147/ORR.S154289. Plantar fibromatosis: Surgical approach of a giant bilateral case. Lupus (SLE), a systemic issue that affects the skin, joints, kidneys, brain, and other organs and can manifest in fatigue, joint pain, fever, and a rash. Ledderhose disease or plantar fibromatosis is a rare condition affecting the bottom of the feet. There is little information about prevalence available, but it is classed a rare disease by the Office of Rare Disease of the American National Institute of Health (ORD . When suffering from Ledderhose disease benign nodules grow at the arch of the foot. A disease in which the immune system unintentionally attacks your body is an autoimmune disease. If noninvasive options do not help, a doctor may recommend surgery to get rid of the painful nodules. All rights reserved. Type 1 diabetes The pancreas produces the hormone insulin, which helps regulate blood sugar levels. Diagnostics (Basel). Can diet help improve depression symptoms? Multiple sclerosis (MS) damages the myelin sheath, the protective coating surrounding nerve cells in your central nervous system. Damage to the myelin sheath slows the transmission speed of messages between your brain and spinal cord to and from the rest of your body. The early symptoms of many autoimmune diseases are very similar, such as: Individual diseases can also have their own unique symptoms. Get useful, helpful and relevant health + wellness information. During a flare-up, your symptoms may get severe for a while. HHS Vulnerability Disclosure, Help Your experience may be different from others, and you should consult your primary care provider for more information. The nodules are usually painless at first but may grow and cause discomfort or pain. There are three stages to Ledderhose disease: Ledderhose disease affects people of any age. In rare cases, the disease is disabling. The site is secure. (https://pubmed.ncbi.nlm.nih.gov/30774465/), Visitation, mask requirements and COVID-19 information, non-steroidal anti-inflammatory medications (NSAIDs), Thickening over the tops of your finger joints (. Even then, recognition of the imaging characteristics of plantar fibromatoses can help in the clinical diagnosis. Individuals with the condition should talk to a doctor before starting any course of treatment. The https:// ensures that you are connecting to the Sudden weakness, especially if you cant move. During sessions, physical therapists may massage the feet and give someone splints to help relieve the nodules. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). This article reviews the top 5 ways to increase your. As such, portions of the diseased tissue may be left in the foot after surgery. For example, type 1 diabetes causes extreme thirst, weight loss, and fatigue. Plantar fibromatosis/Ledderhose disease (LD) is a hyperproliferative non-malignant disorder of unknown cause with low incidence rate of 1-2 cases per 100,000 hospital admissions (Ledderhose 1897; Pickren et al. Ledderhose Disease With Concomitant Presence of Dupuytren Contracture: A Case Report and Review of the Literature Show all authors Do Hyun Yun, BS 1 Do Hyun Yun Division of Plastic Surgery, University of Kentucky, Lexington, KY, USA See all articles by this author Search Google Scholar for this author , Alisha R. Bonaroti, MD 1 Alisha R. Bonaroti Discover the answer to these and other, Psoriasis in children is treatable, but the impact of the disease may go deeper than the skin. Being female 78% of people who have an autoimmune disease are women. Researchers from participating institutions use the database to search for and invite patients or healthy volunteers who meet their study criteria to participate. Diagnosis is based on clinical examination. Experience long-lasting pain in the bottom of your feet. Ankylosing spondylitis is the most common type of spondyloarthritis, a family of arthritis-associated diseases. [2] Occasionally, the nodules may lie dormant for months to years only to begin rapid and unexpected growth. We explain the different characteristics between Crohns disease and ulcerative colitis, which are both part of inflammatory bowel disease (IBD). Mueller RB, et al. Correctly diagnosing Ledderhose disease is important for treatment. Notice the development of growths or bumps near the middle of the bottom of your feet. These lumps form along the plantar fascia the band of tissue that connects your heel bone with your toes. [10], Although the origin of the disease is unknown, there is speculation that it is an aggressive healing response to small tears in the plantar fascia, almost as if the fascia over-repairs itself following an injury. We do not endorse non-Cleveland Clinic products or services. Ledderhose disease or plantar fibromatosis is a rare condition affecting the bottom of the feet. *Birdshot chorioretinopathy / birdshot uveitis. Even though it is benign, the local manifestations can be aggressive, leading to debilitating deformities and contractures of the toes. It is rare, but nodules may appear on the toes, and the pressure from the nodules in the foot can cause the toes to contract. An autoimmune disease predominantly targeting the thyroid gland, and mediated by autoantibodies that bind to and stimulate a receptor expressed on thyroid cells called TSH receptor. There are only three reported cases of polyfibromatosis and keloids with erosive arthritis. Clinical studies are medical research involving people as participants. [2][7], Radiotherapy has been shown to reduce the size of the nodules and reduce the pain associated with them. There is also some evidence that it might be genetic. Singapore Med J. It is histopathologically associated with Dupuytren's disease. Specific symptoms depend on the exact disease. Psoriasis causes skin cells to multiply too quickly. Accessibility Nodules will grow slowly but will stop growing eventually and stay one size. Lesions may be symptomatic because of a mass effect or invasion of adjacent muscles or neurovascular structures. According to several research studies, Celiac disease and Type 1 diabetes share common genetic origins and immune mediated tissue damage. Talk to your healthcare provider about the side effects of medications for blood pressure, statins and antibiotics. (1993). Remember that some people with an autoimmune disease can experience this when theyre pregnant. Here's how it can affect your health. Disney rash is a type of vasculitis, also called golfer's or hiker's rash because it's strongly linked to the kind of walking these activities inspire. This astonishing percentage is a . Many people with autoimmune diseases can live a normal life. Feb 24, 2016 8:17 AM. There are more than 80 autoimmune diseases. itching, stinging sensation in the surrounding area, pain in the ankle joints, which may be made worse by favoring the nodules. Deficiency of aldosterone will lead to sodium loss and excess potassium in the bloodstream. It is a result of overuse. Read about causes and symptoms of this type of heart disease. The immune system usually guards against bacteria and viruses. (2015). Goldenberg MM. Having relatives with autoimmune diseases. Advertising on our site helps support our mission. The nodules are often painless at first, but may cause pain when walking as they grow. It does not seem to be caused by occupation or from trauma. As a result, you may change the way you naturally walk to offset your pain. We would like to hear your feedback as we continue to refine this new version of the GARD website. Barrie WE. A small collection of bumps on the bottom of your foot. Cleveland Clinic offers expert diagnosis, treatment and rehabilitation for bone, joint or connective tissue disorders and rheumatic and immunologic diseases. It has been noted that it is an inherited disease and of variable occurrence within families, i.e. 1951; Seegenschmiedt 2007 ). dupuytrens-society.org.uk/information/ledderhose-disease/, ncbi.nlm.nih.gov/pmc/articles/PMC2945849/, rarediseases.info.nih.gov/diseases/6873/ledderhose-disease, dupuytrens-society.org.uk/treatment/ledderhose-disease/, radiopaedia.org/articles/plantar-fibromatosis. A subtype is a more specific clinical definition of the main disease. It causes inflammation between vertebrae, the bones that make up the spine, and in the joints between the spine and pelvis. Trouble breathing/shortness of breath. PMC Ledderhose disease may cause discomfort. MeSH Symptoms include weakness, fatigue, weight loss, and low blood sugar. The thyroid is a small, butterfly-shaped gland in the front of your neck. These are caused by a thickening in the deep connective tissue (the fascia) in the foot and can cause discomfort or pain when walking. These are caused by a thickening in the deep connective tissue (the fascia) in the foot and can cause discomfort or pain when walking . The bumps may grow to be 1 to 2 centimeters in size. These are caused by a thickening in the deep connective tissue (the fascia) in the foot and can cause discomfort or pain when walking. In 25% of cases, Ledderhose disease affects both feet. Even with successful treatment, there is no guarantee that the nodules will not come back over time. (https://pubmed.ncbi.nlm.nih.gov/28825000/). National Center for Advancing Translational Sciences. Find resources for patients and caregivers that address the challenges of living with a rare disease. SAGE Open Med Case Rep. 2021 Apr 28;9:2050313X211011813. This form of the disease is called psoriatic arthritis. A qualified doctor is the only person who should diagnose this condition. If your primary healthcare provider cant diagnose you, you may have to see a specialist like a gastroenterologist or a rheumatologist. official website and that any information you provide is encrypted The disease is more commonly associated with -, There is also a suspected, although unproven, link between incidence and alcoholism, smoking, liver diseases, thyroid problems, and stressful work involving the feet. [6] Clumping of the fascia at the soles of the feet causes the disease. Our Information Specialists are available to you by phone or by filling out our contact form. Ledderhose disease: An unusual presentation. Other tests are rarely necessary. Dietary intolerances are found in both diseases. A physical therapist may recommend specific exercises based on the location and size of the nodules. There is a higher risk for stillbirth or preterm birth if you have lupus. There are some alternative treatment options for connective tissue disorders, such as Ledderhose disease and Dupuytren contracture, which affects the hands. Optimal management of pernicious anemia. 8600 Rockville Pike Ledderhose disease (plantar fibromatosis) is a rare disease. Should I have surgery for Dupuytren's contracture? Surgical treatment of a case of Ledderhoses disease: A safe plantar approach to subtotal fasciectomy. (2010). Youre more likely to have a recurrence if any of the following applies: Last medically reviewed on August 14, 2017, Even if a lump on the side of your foot isnt causing any pain or other symptoms, its important to have a doctor look at it. There's been a lot of advertising of Enbrel, Humira, etc., for rheumatoid and psoriatic arthritis. Check this site often for new trials that become available. Talk to a trusted doctor before choosing to participate in any clinical study. In rare cases, your toes may curl down toward the bottom of your feet. The cause is unknown. Thyroid hormones control the bodys energy usage, known as metabolism. Its like it can no longer tell the difference between whats healthy and whats not between whats you and whats an invader. Genetics and family . Many people have reported gluten sensitivity, which isnt an autoimmune disease but can have similar symptoms such as diarrhea and abdominal pain. Intralesional fenestration and corticosteroid injection for symptomatic Ledderhose disease of the foot: Two case reports. Dupuytren advocacy is challenging. The overlying skin is freely movable. Federal government websites often end in .gov or .mil. Be sure to get tested quickly if youre experiencing symptoms. However, its more common in men who are middle-aged or older. You can help your healthcare provider with the diagnosing process by bringing the following to your appointment: In addition to interviewing you about your symptoms, your healthcare provider may do some blood tests to check for autoimmune diseases, including: Specific symptoms combined with specific blood markers may prove that you have an autoimmune disease. Downs SM, van Dyck PC, Rinaldo P, et al. [5] The overlying skin is freely movable, and contracture of the toes does not occur in the initial stages. Have you ever been diagnosed with Dupuytrens disease, Peyronies disease, knuckle pads or any other type of fibromatosis? Other things which could pre-dispose you to this condition include diabetes, plantar fasciitis and certain auto-immune diseases. Ask you to walk a short distance and note how your feet and ankles move. is ledderhose disease an autoimmune diseaseis ledderhose disease an autoimmune diseaseis ledderhose disease an autoimmune disease Fausto de Souza D, Micaelo L, Cuzzi T, et al. Examples include: The specialist you need depends on the type of autoimmune disease you have. As the disease progresses, it may cause thickening of the cord and contractures of the digits, which, in turn, can cause pain. Pacinian Corpuscles as a Diagnostic Clue of Ledderhose Disease-A Case Report and Mapping of Pacinian Corpuscles of the Sole. The immune system is involved, but not exactly like an autoimmune disease. The primary symptom of Ledderhose disease is hard lumps on the soles of one or both of your feet. However, there is no guarantee that symptoms will not return. This results in inflammation and damage. Doctors can often identify the disease based on the type of nodule a person has. Expert Answers: Ledderhose disease, sometimes called plantar fibromatosis or "Dupuytren's of the foot," is characterized by lumps called nodules on the underside of the foot. It can occur as a part of Graves ophthalmopathy, which occurs in around 30% of those with Graves disease, according to a 1993 study. [13279] It is generally seen in middle-aged and elderly people, and occurs in men about 10 times more often than in women. Surgery to treat it relieves pain and can prevent Ledderhose disease from coming back. [citation needed], An MRI Scan (Magnetic Resonance Imaging) is usually the imaging of choice to determine between other possible conditions such as ganglion cysts. Plantar fascial fibromatosis, also known as Ledderhose's disease, Morbus Ledderhose, and plantar fibromatosis, is a relatively uncommon[2] non-malignant thickening of the feet's deep connective tissue, or fascia. Ledderhose disease - About the Disease - Genetic and Rare Diseases Information Center National Center for Advancing Translational Sciences Browse by Disease About GARD Contact Us We recently launched the new GARD website and are still developing specific pages. Which autoimmune diseases run in your family? "Dupuytren's Disease and Related Hyperproliferative Disorders" (Springer, Heidelberg & New York, 2012) p 409-428. What Is This Lump on the Side of My Foot? Policy. For how long? Last medically reviewed on September 9, 2017, Severs disease is an inflammation that affects the heel. As in most forms of fibromatosis, it is usually benign and its onset varies with each patient. Without enough of this vitamin, one will develop anemia, and the bodys ability for proper DNA synthesis will be altered. Graves ophthalmopathy. Policy. Other people may find that they need regular intervention to simply keep symptoms tolerable. Usually, the immune system can tell the difference between foreign cells and your own cells. It's unclear why your immune system does this. These lumps form along the plantar fascia the band of. Hayter SM, et al. The growths arent cancerous, but they can cause pain, especially when you walk. Chronic inflammatory demyelinating polyneuropathy (CIDP). Other tests look for specific autoantibodies produced in certain autoimmune diseases. /. People with Ledderhose disease may also have other conditions associated with the formation of excess fibrous connective tissue such as Dupuytren contracture, knuckle pads, or Peyronie disease. Less often, the disease gets worse slowly over time. The etiology, evaluation, and management of plantar fibromatosis. Second, any treatments out there are systemic and, frankly, dangerous. Some autoimmune diseases are more common in certain ethnic groups. You can learn more about how we ensure our content is accurate and current by reading our. What activities should I avoid? Your doctor can use your symptoms and other tests to confirm the diagnosis. During a massage, it is important to avoid the nodules themselves, as they can be very painful when touched. Ledderhose Disease An Unusual Presentation. 50.1 <a title="Top Natural Treatments For Ledderhose And Plantar Fibroma" class . Whenever is possible, the conservative therapies are recommended. Hashimoto's disease is an autoimmune disorder that can cause hypothyroidism, or underactive thyroid. In rare cases, your toes may curl down. This disease has some risk factors, like old age, alcohol or nicotine abuse, liver dysfunction, trauma or exposure to vibrations and autoimmune disorders, but the exact etiology is still unknown. Use ClincalTrials.gov button below to search for studies by disease, terms, or country. A larger challenge is that no one knows the root biology of Dupuytren/Ledderhose/Peyronie disease - how it starts, or . Unlike osteoarthritis, which commonly affects people as they get older, RA can start as early as your 30s or sooner. The fitness personality revealed she's "fragile," suffering from three autoimmune diseases. In type 1 diabetes mellitus, the immune system attacks and destroys insulin-producing cells in the pancreas. There are many home remedies that people can take to help treat the disorder or reduce its symptoms. Disclaimer. [7] There has also been variable success in preventing recurrence by administering gadolinium. Role of Western diet in inflammatory autoimmune diseases. ClinicalTrials.gov, an affiliate of NIH, provides current information on clinical research studies in the United States and abroad. Gentle stretching of the foot may help ease tight connective tissues in the feet. People with Ledderhose disease may also have other conditions associated with the formation of excess fibrous connective tissue such as Dupuytren contracture, knuckle pads, or Peyronie disease. Your feet may become swollen, and the growths on your feet may be painful. You can treat Ledderhose disease in its earliest stages with shoe inserts, massages, stretching, ice and over-the-counter medications. Anyone from the U.S. can register with this free program funded by NIH. Talk to your primary healthcare provider or dietitian about an ideal nutrition plan. Radiation therapy may help prevent disease from getting worse, and may also improve symptoms. BOTTOM LINE: Symptoms like fatigue, muscle aches, swelling, and redness could be signs of an autoimmune disease. It usually occurs before the age of 15 years. Do you have a biological family history of Ledderhose disease? What Is Tracheal Deviation, and Hows It Treated? If these treatments dont work and the lump is very painful, your doctor might recommend a type of surgery called fasciectomy. Research has linked a number of viral and bacterial infections to autoimmune disease, including Epstein-Barr (the virus that causes mono), Herpes Simplex 1 and 2, E. coli, and more. The immune system is involved, but not exactly like an autoimmune disease. Tell your healthcare provider if you have Dupuytrens disease, Peyronies disease or knuckle pads. Common ones include lupus, rheumatoid arthritis, Crohn's disease and ulcerative colitis. [5], MRI and sonogram (diagnostic ultrasound) are effective in showing the extent of the lesion, but cannot reveal the tissue composition. A period of symptoms is called a flare-up. Healthline Media does not provide medical advice, diagnosis, or treatment. Ocampo-Garza J, Azevedo Cunha R, Silva Pereira C, Sanderson A, Pinto-Desmond K, Machado-Filho CD, Haneke E, Marques de Carvalho M. Int J Dermatol. FOIA It may not be possible to prevent autoimmune diseases. Coming to a Cleveland Clinic location?Hillcrest Cancer Center check-in changesCole Eye entrance closingVisitation, mask requirements and COVID-19 information, Notice of Intelligent Business Solutions data eventLearn more. On darker skin, psoriasis can appear purplish or dark brown with gray scales. The disease got its name from German surgeon Dr. Georg Ledderhose, who first described it in 1894. Too little cortisol can affect how the body uses and stores carbohydrates and sugar (glucose). Many autoimmune diseases are more common in women than in men. Treatments include medications to calm the overactive immune response and bring down inflammation in the body. Having too much of these hormones revs up your bodys activities, causing symptoms like nervousness, a fast heartbeat, heat intolerance, and weight loss. However, it seems to occur in those who have other types of fibromatosis. Is radiographic progression of late-onset rheumatoid arthritis different from young-onset rheumatoid arthritis? Learn about psoriasis triggers, medications, and coping, Juvenile idiopathic arthritis is the most common type of arthritis in children. Note, GARD cannot enroll individuals in clinical studies. (2014). Autoimmune diseases are a broad range of related diseases in which a person's immune system produces an inappropriate response against its own cells, tissues and/or organs. Experts dont know why your immune system turns on you. People with celiac disease cant eat foods containing gluten, a protein found in wheat, rye, and other grain products. Many collaborate with medical experts and researchers.Services of patient organizations differ, but may include: Clinical studies are part of clinical research and at the heart of all medical advances, including rare diseases. Severe chest pain/pressure to your chest. Recently, new-onset autoimmune phenomena after COVID-19 vaccination have been reported increasingly (e.g. Benign diseases that can benefit from radiation therapy include certain inflammatory conditions of the hands or feet. Follow your healthcare providers instructions for at-home treatments. Repeated trauma, long-term alcohol consumption, chronic liver disease, diabetes, and epilepsy have also been reported in association with this condition Researchers have several ideas about why this happens. They can also become inflamed and irritated, which may make the pain worse. Learn about juvenile idiopathic arthritis symptoms, diagnosis, and, Healthline has strict sourcing guidelines and relies on peer-reviewed studies, academic research institutions, and medical associations. Fri Mar 3 2023 - 06:01. It tightens the ligament on the bottom of your foot (plantar fascia) and can predispose you to developing plantar fasciitis. You can learn more about how we ensure our content is accurate and current by reading our. But, some experts recommend that you try: Your autoimmune disease symptoms may change with time. Yes. Ritchlin CT, et al. Manzel A, et al. [6], The typical appearance of plantar fibromatosis on magnetic resonance imaging (MRI) is a poorly defined, infiltrative mass in the aponeurosis next to the plantar muscles. Doctors dont know exactly what causes the immune system to misfire. Although they cant be cured, some of the symptoms can be treated. When it senses these foreign invaders, it sends out an army of fighter cells to attack them. Autoimmunity and the gut. Learn how they compare. With autoimmune diseases like psoriasis or RA, symptoms may come and go. government site. Ledderhose Disease - Long Term Effects of Radiotherapy Treatment. Ledderhose Disease can be pain-free, but especially as the fibromas get larger, many patients experience a considerable amount of pain standing and walking on the affected foot. Cleveland Clinic offers expert diagnosis, treatment and rehabilitation for bone, joint or connective tissue disorders and rheumatic and immunologic diseases. If you have leukocytoclastic vasculitis, it means the small blood vessels in your skin are inflamed. Some are well known, such as type 1 diabetes, multiple sclerosis, lupus, and rheumatoid arthritis, while others are rare and difficult to diagnose. In people with Hashimoto's disease. Some diseases are genetic they run in families. Learn more about the causes, symptoms, and treatment of plantar fasciitis here. The term Autoimmune Disease is used to describe conditions in which the body's immune system - which is supposed to be defending the body against viruses, bacteria and other invaders - is thought to be involved in causing or perpetuating illness. It is a similar condition to Dupytren's contracture which occurs in the hand causing flexion of the fingers. Many autoimmune diseases affect more than one part of the body. One potential symptom of this disease is bulging eyes, called exophthalmos. Lerner A, et al. Its primary function is to supply blood to the lower section of the body. Though rare, the thickened skin can pull back on your toes. Diseases like lupus, rheumatoid arthritis and multiple sclerosis are complex and serious. Tracheal deviation can be caused by various conditions. Not every nodule on the foot is a sign of the condition, and different disorders will require altogether different therapies. Additionally, feet have to carry heavy load, and surgery might have unpleasant side effects. The Role of Infection and Disease. 2019 May;60(5):230-235. doi: 10.11622/smedj.2019043. Autoimmune thyroid disease (AITD) is composed of two main classifications: Graves' disease (GD) and Hashimoto's thyroiditis (HT). The disease is included in several widely used lists of autoimmune disease and is shown here to ensure that a person visiting this page does not conclude that the disease was not considered. They are poorly protected by fat and therefore prone to injury. The diseases are common 1 in 15 people in the U.S. have an autoimmune disease. This site needs JavaScript to work properly. Take steps toward getting a diagnosis by working with your doctor, finding the right specialists, and coordinating medical care. Ledderhose disease or plantar fibromatosis is a rare hyperproliferative disorder of the plantar aponeurosis, clinically characterized by nodules situated especially on the medial border of the foot. Risk factors are alcohol use, diabetes, and smoking. Other diseases, like systemic lupus erythematosus (SLE), or lupus, can affect the whole body. Many of my forum friends on facebook post this same thing. Eating a well-balanced diet and getting regular exercise may also help you feel better. Autoimmune vasculitis happens when the immune system attacks blood vessels. eCollection 2021. Ledderhose disease: an unusual presentation. The exact cause of Ledderhose disease is not known, but heredity is thought to play a role in many cases. 2004-2023 Healthline Media UK Ltd, Brighton, UK, a Red Ventures Company. You may see small, hard growths in the bottom of your foot. [3][4] A similar disease is Dupuytren's disease, which affects the hand and causes bent hand or fingers. What type of autoimmune disease do I have? The fascia is a layer of connective tissue that runs throughout much of the body. The condition is more common after age 40. What Can Be Done to Get Rid of the Nodules? Some autoimmune diseases run in families. Yes, but it may be more difficult if your symptoms are severe. This treatment is also used for Dupuytrens contracture. Each type of IBD affects a different part of the GI tract. Types include rheumatoid arthritis, Crohns disease, and some thyroid conditions. They look like bumps, knots or growths on the surface of your skin. LedRad LTE - Study: Actual Study Start Date : May 13, 2019: Actual Primary Completion Date : January 31, 2020: Actual Study Completion Date : January 31, 2020: Resource links provided by the National Library of Medicine.
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