225 Clinical Trials for Various Conditions
Topical timolol, a β2-Adrenergic receptor (B2AR) antagonist, has demonstrated promise in wound healing over the past several years. The majority of the literature has evaluated the use of topical timolol to shorten wound healing time in chronic wounds of non-surgical etiologies. To date, there are no prospective randomized clinical trials evaluating the role of topical timolol for shortening wound healing time in acute open surgical wounds. Therefore, the purpose of this study is to determine whether or not topical timolol solution decreases time to wound healing in patients with defects after Mohs Micrographic Surgery (MMS) that cannot be closed with sutures and are left to heal by second intent. The research team also will look to determine if there is a difference in cosmesis of wounds treated with topical timolol compared to those treated with the standard of care. The present study will primarily focus on wounds in the distal lower extremity as these are most commonly left to heal by secondary intent
The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility).
This is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with leg pain. A set of psychosocial surveys assessing activity-related fear, stress, anxiety and depression will be completed by the participants. Participants will then complete self-report questionnaires assessing pain, quality of life and functional ability followed by an assessment of physical activity levels assessed with a wearable activity monitor;. Participants will then be randomized into one of two intervention groups (psychologically-informed video education group and a control group). After participants receive their assigned educational intervention, the self-report questionnaires will be re-administered. Participants with leg pain pain will then complete follow-up assessment of their psychological beliefs, pain, quality of life, physical activity levels, and self-reported functional ability through REDcap at 1 week, 4 weeks, 3 months, 6 months, and 1 year.
The purpose of this study is to find out if an advance balance perturbation training program can enhance the rehabilitation process by increasing weight-bearing strategies on the prosthetic or injured limb, and, help reduce stumbles and falls.
The objective of this study is to determine if patients with lower extremity wounds in rural communities who undergo specialty referral through telemedicine have expedited care compared to patients who are treated through standard in person referral.
The study will prospectively enroll and follow 300 participants ages 18-60 surgically treated for a lower-extremity articular injury including fractures of the tibial plateau, pilon, ankle, and calcaneus.
Patients who meet the inclusion criteria will be provided with fibrillar collagen powder dressing. The powder dressing will be used in accordance with its label. After cleansing the wound by the clinical site staff, the powder is placed directly on the wound, and then the wound will be covered with an appropriate moisture retentive secondary dressing. Patients will visit the clinic twice a week to have the powder re-applied. Wound evaluations will take place once a week at the outpatient clinic, with the intervention lasting up to twelve weeks. Concurrent standard of care, such as compression for venous ulcers, will be provided.
Patients who meet the inclusion criteria will be provided with fibrillar collagen powder dressing. The powder dressing will be used in accordance with its label. After cleansing the wound by the clinical site staff, the powder is placed directly on the wound, and then the wound will be covered with an appropriate moisture retentive secondary dressing. Patients will visit the clinic twice a week to have the powder re-applied. Wound evaluations will take place once a week at the outpatient clinic, with the intervention lasting up to twelve weeks. Concurrent standard of care, such as compression for venous ulcers, will be provided.
This study will evaluate the efficacy and safety of laser therapy on postoperative lower extremity wound healing over 12 weeks. The investigators will include adult patients who have underwent Mohs Micrographic Surgery on their lower extremities. Patients with poor immune systems, current pregnancies, uncontrolled diabetes, lower extremity venous or arterial disease will not be included in this study. After surgery patients will be randomized into two groups. One group will receive a single laser treatment immediately after their surgery on their wound while the other will not. The group not receiving laser therapy will undergo a sham laser therapy treatment. Immediately after therapy and 4, 8, and 12 weeks postoperative patients will have a follow up visit. During these visits patients wound size will be recorded, a photograph will be taken, and the wound temperature will be measured. Patient will be given a diary to record any adverse events related to the wound.
The purpose of this study is to develop algorithms that will help predict future injury and/or re-injury after being returned to duty from a musculoskeletal injury. After completion of an episode of care with a physical therapist, the subjects will undergo a battery of physical performance tests and fill out associated surveys. The subjects will then be followed for a year to identify the occurrence/re-occurence of any injuries. Based on the performance on the physical evaluation tests, algorithms will be derived using regression analysis to predict injury. Subjects will be recruited from the pool of patients that have recently completed physical rehabilitation in physical therapy clinics for their lower extremity or lumbar/thoracic spine injury.
The primary purpose of this study is to determine the degree of loss of epidermal nerve fibers near a foot wound in patients with diabetic foot ulcers. The secondary purpose will be to determine whether the degree of epidermal nerve fiber loss, the clinical examination, nerve conduction studies or the molecular profile correlates with appearance of lower extremity ulcers in patients with diabetes.
Wound healing rate is higher when contact ultrasound therapy is followed by noncontact ultrasound therapy on sub-acute and chronic lower extremity ulcers of various etiologies requiring selective debridement, as compared to either Sonoca-180 or MIST Therapy alone.
A prospective, single blinded randomized clinical study will be performed to determine if the injection of lipoaspirate into diabetic or venous stasis wounds promotes wound healing or wound closure at a faster rate than conventional treatment.
The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in adults who have had a lower limb injury.
This study evaluates the use of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of chronic leg wounds in adults. All participants will use Prontosan and report their personal observations regarding Quality of Life.
Study hypothesis :Hyperbaric Oxygen may prevent complications and improve outcomes in severe lower limb trauma. We propose to investigate this hypothesis by conducting an International multi centre randomised control trial of standard trauma/orthopaedic care with or without a concurrent course of hyperbaric oxygen treatments.
The purpose of this study is to determine the efficacy and safety of compression bandaging with fractional ablative carbon dioxide laser (FACL) compared to compression and standard dressings alone for healing of post-operative wounds of the leg. This is a randomized, SMART design, clinical trial. Approximately 80 participants will be randomized to initially receive compression bandages or standard wound dressings after surgery on the lower leg. After 4 weeks, the group assigned to compression bandages will be further randomized to either continue with the compression bandages only or continue with the compression bandages and also receive (FACL). The study is designed as an 6-month study. This study was a pilot study designed to determine feasibility of these procedure. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings alone in the treatment of Venous Leg Wounds
Most chronic (long-lasting) wounds of the leg (also known as venous ulcers) fail to heal in a reasonable period of time. Although researchers have made great progress in understanding how the body repairs wounds, attempts to develop new treatments have been disappointing. In general, treatments based on recent findings about the details of wound repair have not greatly reduced the number of people who have chronic wounds. The long-term goal of this study is to evaluate a new approach for healing a chronic wound. Current methods of directly applying substances that are involved in wound healing to a chronic wound do not cause enough healing. PDGF-B (platelet-derived growth factor B), a factor associated with wound healing, might dramatically enhance healing if a genetically engineered virus is injected into the wound that causes cells in the wound to produce PDGF-B in large quantities.
The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.
The goal of the CBPT study is to determine the efficacy of the CBPT program for improving outcomes in service members and civilians at-risk for poor outcomes following traumatic lower-extremity injury. Primary outcome is physical function measured through a patient-reported questionnaire and physical performance tests. Secondary outcomes include pain and general health. Tertiary outcome is return to work/duty.
This study would like to determine if using negative pressure wound therapy with an instillation of .125% Dakins is more effective than using negative pressure wound therapy alone on biofilm removal, disruption and elimination in chronically infected lower extremity wounds.
Carbon fiber custom dynamic orthoses (CDOs) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. CDOs and unloading AFOs have shown differing offloading capabilities across different regions of the foots (hindfoot, midfoot, forefoot) which may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate. The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion during gait as well as patient reported pain, and comfort.
The primary objective of the study is to determine the efficacy of blood flow restriction therapy on patients with lower limb extensor injuries by measuring pre and post blood flow restriction therapy strength and muscle mass.
The increased metabolic and biomechanical demands of ambulation limit community mobility in persons with lower limb disability due to neurological damage. There is a critical need for improving the locomotion capabilities of individuals with stroke to increase their community mobility, independence, and health. Robotic exoskeletons have the potential to assist these individuals by increasing community mobility to improve quality of life. While these devices have incredible potential, current technology does not support dynamic movements common with locomotion such as transitioning between different gaits and supporting a wide variety of walking speeds. One significant challenge in achieving community ambulation with exoskeletons is providing an adaptive control system to accomplish a wide variety of locomotor tasks. Many exoskeletons today are developed without a detailed understanding of the effect of the device on the human musculoskeletal system. This research is interested in studying the question of how the control system affects stroke biomechanics including kinematic, kinetics and muscle activation patterns. By optimizing exoskeleton controllers based on human biomechanics and adapting control based on task, the biggest benefit to patient populations will be achieved to help advance the state-of-the-art with assistive hip exoskeletons.
The increased metabolic and biomechanical demands of ambulation limit community mobility in persons with lower limb disability due to neurological damage. There is a critical need for improving the locomotion capabilities of individuals who have walking impairments due to disease to increase their community mobility, independence, and health. Robotic exoskeletons have the potential to assist these individuals by increasing community mobility to improve quality of life. While these devices have incredible potential, current technology does not support dynamic movements common with locomotion such as transitioning between different gaits and supporting a wide variety of walking speeds. One significant challenge in achieving community ambulation with exoskeletons is providing an adaptive control system to accomplish a wide variety of locomotor tasks. Many exoskeletons today are developed without a detailed understanding of the effect of the device on the human musculoskeletal system. This research is interested in studying the question of how the control system affects human biomechanics including kinematic, kinetics and muscle activation patterns. By optimizing exoskeleton controllers based on human biomechanics and adapting control based on task, the biggest benefit to patient populations will be achieved to help advance the state-of-the-art with assistive hip exoskeletons.
IV and included steroids have produced the same length of block prolongation in adults as if the steroid was given with the nerve block. Clinically, this has not be noticed in children. The objective of this study is to examine this in young patients. The investigator will blindly give the steroid either in the IV or in the block solution (perineural). This is a prospective double blind study.
The goal of the PRIORITI-MTF study is to help determine whether a new type of custom designed brace, called the IDEO ™ along with a physical therapy program, called Return to Run, improves physical function. This brace was developed for wounded warriors who wanted to return to an active lifestyle. The primary objective of this study is to examine the benefits (and cost-benefits) of an integrated orthotic and rehabilitation program that incorporates the Intrepid Dynamic Exoskeletal Orthosis (IDEO) and the Return to Run (RTR) physical therapy regimen, but designed for scalability in the broader military environment (i.e. beyond San Antonio Military Medical Center where the program was developed)
Evidence supports the use of two dimensional video analysis to assess the presence of dynamic knee valgus during generally used screening tasks, however there is limited evidence to support the use of the various smart phone applications as a time and money saving option for clinic use . Subjects that present to the clinic and display dynamic valgus at the knee during the lateral step down test will be given the option to participate in the study. If they consent to the study they will be evaluated with 2-Dimensional video analysis to determine the amount of valgus present at the knee during the lateral step down test. The subject will also have the smart phone attached to their lower leg and the amount of valgus will be concurrently measured by the selected application. The primary objective of this study is to determine the validity of an application on the smart phone to provide an objective measure of dynamic knee valgus. The secondary objective of this study is to determine the possibility of the use of the application as a source of feedback during neuromuscular re-education training in order to decrease or eliminate a subject's dynamic valgus collapse and subsequently decreased their risk for future injury.
Sports-related injuries are a serious concern for physically active children and adolescents. Previous research, including ours at Chicago public high schools, shows our neuromuscular training program, the Knee Injury Prevention Program (KIPP) reduces sports-related injuries in female athletes by up to 88%. However, KIPP is not well-studied in males or younger age groups. This project aims to determine KIPP's effect on sports-related injuries and physical fitness among 5th-8th grade students in Chicago public schools. The study will take place during the 2011-2013 school years. To measure KIPP's effect on sports injuries, we will recruit 5th-8th grade sports coaches and their athletes, randomize coaches by school into two groups, then train the intervention group to implement a 10-minute KIPP warm-up before practices and games. Control group will perform their usual warm-up. Research assistants will collect athlete participation and injury data from coaches weekly. To determine feasibility of KIPP in PE classes and measure its effect on fitness, we will recruit PE teachers to implement the warm-up in PE classes for a minimum of 10 weeks, and record students' presidential fitness test scores before and after the 10+ weeks. Results of this study will guide strategies for preventing sports-related injuries and improving physical fitness in 5th -8th graders.