221 Clinical Trials for Various Conditions
The purpose of this study is to determine if individuals with incomplete spinal cord injury (SCI) who remain unable to walk normally 1 year after their SCIs are able to sense and move the affected legs better after 10-13 weeks of treatment with a new robotic therapy device. The hypothesis is that using the AMES device on the legs of chronic subjects with incomplete SCI will result in improved strength, sensation in the legs, and improved functional gait in the treated limbs.
Athletic injury can result in decreased athletic performance or removal from sport participation. There may also be psychological and financial impacts of athletic injury. Additionally, there can be long-term consequences, such as increased risk of subsequent injury or arthritis. Therefore, determining ways to prevent athletic injury from occurring is critical. Movement quality during sport is related to injury risk. Athletes who move poorly are generally at increased risk of injury compared to athletes who move well. Movement quality can be improved through exercise-based injury prevention training, thereby decreasing injury risk. This purposed of this study is to evaluate movement quality multiple times over the course of an athletic season in collegiate athletes who perform injury prevention training. The hypothesis is that movement quality will improve over the course of an athletic season.
The purpose of this study is to test whether measures of balance and agility can help predict if a Service Member may be at risk for an injury to their legs before beginning their school and training.
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.
The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Participants will be asked to wear the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.
The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Participants will be asked to wear Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.
This research is being done to compare two different methods of wound monitoring for chronic wounds: remote wound monitoring using a smartphone app and in-person wound monitoring in a clinic setting. This will be a pilot non-blinded randomized controlled feasibility trial. The investigators will enroll 120 patients with an active diabetic foot ulcer (DFU) who present to the multidisciplinary diabetic foot clinic in Baltimore, Maryland. Patients will be computer randomized 1:1 to receive wound care monitoring using remote DFU monitoring technology or standard in-person monitoring for 12 weeks.
The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute orthopedic injury.
Hypothesis: Elevated miR210 in the epidermis (outer layer of skin) of ischemic human wound edge tissue (tissue that has a lack of blood flow to it) is associated with poor healing outcome in a setting of standard clinical care. Aim of the study: To determine whether elevated miR-210 in the epidermis of ischemic human wound edge tissue is associated with poor healing outcome in a setting of standard clinical care. This study will last 14 weeks. Adult patients, who are non-diabetic or tightly controlled diabetic, and, who have chronic venous leg ulcers that have been open/not healed for at least 12 weeks, will be enrolled in this study. Patients will be recruited from the Indiana University Health Comprehensive Wound Center (CWC). On days 0, 14 and 28, patients will have the following performed: measurements and photographs taken of their wound; TCOM (transcutaneous oxygen measurement) or ABI to measure the amount of oxygen in the wound tissue, if receiving a tissue biopsy; and two 3-mm punch biopsies from the same wound/ulcer. Biopsies will not be taken if the wound has closed by day 14 or day 28. Additionally, patients' medical records will be reviewed throughout the study for 98 days (14 weeks) after enrollment to determine the final status of the wound as healed or not-healed. ABI will be completed per study personnel at initial visit for all consented subjects to ensure subject eligibility (as listed TCOM\<30 mmHg in exclusion criteria). If ABI's are unable to be obtained, TCOM will be performed. There will be a total of 5 visits for this study (6 total visits for patients with open wounds on day 28 of the study). Visits will occur on days 0, 7, 14, 21,28.
This study will train War Fighters with lower extremity trauma to decrease fall risk.
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.
Large full-thickness skin defects, such as those resulting from trauma, large and giant congenital nevi, disfiguring scars, or tumor resection remain major clinical problems to patients and physicians. Skin flaps and grafts represent the current standard of care (SOC), but often present limitations associated with surgical morbidity and donor site availability. The investigators will enroll 64 patients who have their skin cancer surgically removed and require reconstructive procedure such as a skin flap/graft. To objective of this study is to assess the efficacy and safety of a nanofat-seeded biological scaffold versus the SOC in healing larger surgical defects (\>1.5cm) involving the lower limb that cannot be closed by direct suture and thus need a reconstructive procedure such as a skin flap/graft.
One technique for the nerve block involves injecting the numbing medicine where the nerve is together (higher up in the back of the thigh). The other technique involves injecting the numbing medicine where the nerve splits into two parts. By injecting numbing medication around the nerve(s), there will be less pain after the procedure. It is thought that the numbing medicine will be easier to inject in the group that the nerves are split. It is expected that subjects may need less pain medication and have lower pain ratings in this group too.
The purpose of this study is to compare injecting local anesthetic (numbing medication) in different patterns around a major nerve in the leg. Patients who undergo surgery to the lower leg and/or foot are usually offered the option of a nerve block to help with pain control after surgery. A nerve block involves injecting local anesthetic (numbing medicine) by a nerve or nerves that provide sensation to the area where surgery will be performed. The local anesthetic (numbing medication) numbs up the area where the surgery is performed and helps decrease the amount of pain felt after surgery. The local anesthetic (numbing medication) can be injected in various patterns by a nerve, such as in one spot by a nerve or completely surrounding a nerve. The local anesthetic will be either injected around the sciatic nerve or will injected in a way that will split the sciatic nerve into the two component nerves that make it up, the tibial and sciatic, and surrounds each nerve. The hypothesis is that subjects in the group that local anesthetic is injected in a pattern that separates the sciatic nerve into the two component nerves may have a faster onset time of regional anesthesia and block success than subjects in the group that have the local anesthetic injected at around the nerve.
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.
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.
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.
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.
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 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.
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).
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 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.
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.
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
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.
Researchers are performing this study to evaluate if intraoperative angiography can be shown numerically to determine which wounds are at high risk of wound necrosis/breakdown.