In short
This article provides information about ongoing clinical trials for Thromboangiitis Obliterans, a rare condition affecting blood vessels in the arms and legs. Currently, there is 1 active trial testing new treatment approaches for this condition. (Also known as: Buerger's Disease)
Clinical trial locations
Study on Botulinum Toxin Type A for Treating Buerger's Disease in Patients Eligible for Injection Therapy
This clinical trial is exploring whether Botulinum Toxin Type A can be used as an effective treatment for people living with Buerger's disease. The condition causes inflammation and blood clots in small and medium-sized blood vessels, leading to reduced blood flow and pain in the arms and legs. In severe cases, it can result in tissue damage and ulcers.
Main inclusion criteria: To participate in this study, you must be at least 18 years old and have Buerger's disease as defined by established medical criteria (Olin criteria). You need to have severe digital ischemia, which means poor blood flow to your fingers or toes, accompanied by significant pain or skin problems lasting at least 15 days. Specific blood pressure measurements in your affected limbs must meet certain thresholds to qualify. You must also be able to attend study visits, complete a daily study diary, and be covered by Social Security.
Main exclusion criteria: The trial information indicates that patients with Buerger's disease cannot participate, which appears to be an error in the source data. Typically, exclusion criteria would include factors that make the treatment unsafe or that could interfere with study results.
Focus and goal: The trial aims to evaluate whether using Botulinum Toxin Type A injections is a feasible treatment option for managing symptoms of Buerger's disease. Researchers will monitor several health parameters throughout the study, including blood flow in affected areas, pain levels, and healing of any ulcers or sores. The study also tracks the frequency and severity of Raynaud's syndrome episodes, where fingers or toes may turn white or blue in response to cold temperatures. Quality of life questionnaires will help researchers understand how the treatment affects participants' daily lives.
Investigational drug: Botulinum Toxin Type A is the medication being tested in this trial. It is a protein substance that blocks nerve signals causing muscles to contract, which can help reduce pain and potentially improve blood flow. In this study, it is prepared as a powder mixed into a solution and injected into the body. Participants will receive planned injections at specific timeframes, with follow-up assessments at one month, three months, and six months after treatment to monitor effectiveness and safety.
The trial involves several stages: an initial visit to confirm eligibility, baseline health assessments using various measuring tools (including laser Doppler, thermal camera, and oxygen level measurements), treatment administration, and regular follow-up visits. Throughout the study, researchers will document any changes in symptoms, ulcer healing, and overall quality of life to gather comprehensive data about this potential treatment approach.
Summary
Currently, there is one active clinical trial for Thromboangiitis Obliterans, taking place in France. This trial focuses on testing Botulinum Toxin Type A as a potential treatment option for patients experiencing severe symptoms of the disease, particularly those with poor blood flow to their fingers or toes. The study represents an innovative approach to managing this rare vascular condition, which is often associated with tobacco use.
The trial emphasizes comprehensive monitoring of participants, including objective measurements of blood flow, pain assessment, ulcer healing, and quality of life evaluations. This thorough approach aims to provide detailed information about both the feasibility and effectiveness of this treatment method. For patients living with Buerger's disease who meet the specific criteria and are located in France, this trial may offer access to a new therapeutic approach that could help manage their symptoms and improve their daily functioning.
