Active clinical trials for "Wounds and Injuries"

Knee injuries are common among active-duty military personnel. One of the most common knee injuries is a meniscus tear, which can have several consequences. Immediately, the soldier may be separated from the military for over one year or assigned a permanent activity limiting duty profile. Over time, meniscal tears may also increase the risk of other knee injuries, such as osteoarthritis, which is one of the most common medical reasons for discharge from active duty service. The current standard of care includes conservative treatments, such as physical therapy and rest. Once conservative treatments fail, surgery is generally the next option. However, there is limited evidence that surgery is effective and some studies suggest it can accelerate the development of osteoarthritis. The goal of this study is to evaluate the efficacy of a regenerative treatment for meniscal tears termed micro-fragmented adipose tissue in reducing pain and restoring activity levels. We will recruit active-duty military personnel and civilians with meniscal tears and provide them with either the adipose tissue treatment or a control treatment consisting of saline. We will then follow these individuals for up to one year and evaluate differences in pain and function between the two groups. The ultimate goal is to show that micro-fragmented adipose tissue is a viable alternative for the treatment of meniscal tears in active-duty military personnel.

The clinical investigation plan will include a Screening/Baseline visit (V1) in which patients will be screened on the basis of inclusion/exclusion criteria and clinically evaluated. Screened and eligible patients will be randomly assigned in one of the two groups: Group 1 will receive ConnettivinaBio Plus cream whereas Group 2 will receive ConnettivinaBio cream. Lesions will be cleaned and a photo will be acquired with a digital camera. In both groups, the schedule treatment will consist of daily medication changes. Wound Bed Score, clinical signs of localized infection, measurement of the wound area, collection of the swab, according to the Levine's technique, EQ-5D questionnaire to the patient will be assessed on Day 1 (V1, baseline visit), 7 (V2), 14 (V3), 21 (V4) and 28 (V5) post-baseline. Treatments in both groups (ConnettivinaBio Plus or ConnettivinaBio) will be applied for a maximum period of 28 days. The easiness of treatment application will be also recorded at V5.

Traumatic brain injury (Traumatic brain injury, TBI) can be derived from various forms of injury, including blunt trauma, penetrating or acceleration/deceleration force caused by head injury.There are some study data show that acupuncture treatment has a superficial effect on the prognosis of traumatic brain injury and can limit the progression of secondary brain injury, but the effect of early bloodletting at the Jing-points on TBI patients still unknown. In our study, the investigators have proposed a randomized, controlled study design and plan to evaluate the efficacy and safety of Jing-point puncture to improve consciousness and neurological function in patients with TBI. In addition, an objective meridian instrument analysis was added to analyze the energy distribution in the meridian of TBI patients.

This study aims to compare the efficacy and clinical tolerability of two medical devices in gauze and cream containing the aqueous extract of triticum vulgare and polyhexanide in comparison with two medical devices containing hyaluronic acid and silver sulfadiazine in the treatment of acute skin lesions . The reason why the two types of devices are compared is because hyaluronic acid and silver sulfadiazine represent the gold standard for the treatment of acute skin lesions. Therefore, making a comparison between the activity of the aqueous extract of triticum vulgare and polyhexanide and this gold standard of control in the treatment of acute skin lesions, is useful to better define the efficacy and tolerability of both medical devices in order to eventually expand the therapeutic armamentarium available for the treatment of acute skin lesions

Post market surveillance study to confirm the safety and performance of Silicone Subcategory of PHMB Foam Dressings in Chronic and Acute Wounds.

The purpose of this study is to see if it's possible to reach high cardiovascular intensity training parameters (exercise at a rate that elevates heart rate to the level recommended for improving strength and endurance) while walking in a wearable robotic exoskeleton. This study will also evaluate if exercising at high intensity will lead to improvement in walking ability. Participants in this study will be asked to attend 5 walking training sessions using Ekso exoskeleton. There will be two additional sessions, one before and one after the five training sessions. At these two sessions, study participants will be asked to participate in seated balance, walking speed and endurance tests and breathing assessments.

The purpose of this study is to evaluate safety of Deep Brain Stimulation (DBS) of the lateral hypothalamus (LH) and whether the use of DBS can increase motor performance in patients with chronic spinal cord injury (SCI). The hypothesis, based on preclinical findings, is that DBS of the lateral hypothalamus can acutely augment leg motor function after SCI, and that the use of lateral hypothalamus DBS can be an adjunct during rehabilitation to promote recovery and long-term neuroplasticity.

Lack of current consensus on the therapeutic management of low-grade osteo-ligament injuries in ankle trauma in children. Several types of immobilization are evaluated in the literature, with different conclusions. Some teams recommend a functional treatment similar to the adult (with or without strict immobilization), others remain on standard rigid immobilizations. The goal of the study is to simplify and homogenize the therapeutic management of low-grade osteo-ligament injuries in ankle trauma in children.

Falls are a health crisis that cost health care systems billions of dollars/year. This crisis is especially relevant for individuals living with incomplete spinal cord injury (iSCI); 78% fall at least once annually. In able-bodied individuals, falls are prevented by taking reactive steps; however, these reactions are impaired after iSCI. Research in stroke and geriatric rehabilitation showed that reactive balance training (RBT), which targets reactive stepping, prevents falls. We developed a modified version of RBT for the iSCI population. RBT resulted in fewer falls post-training compared to dose-matched, conventional balance training. However, only those who were able to take a step independently and without upper limb support were able to participate in RBT, limiting the applicability of this promising fall prevention method. To address this limitation, we will integrate functional electrical stimulation into RBT (RBT+FES). Our study aims to provide a preliminary evaluation of the efficacy of RBT+FES in participants with chronic, motor iSCI. We will complete a pilot randomized clinical trial (RCT) with 22 participants with iSCI. Participants will be randomly allocated to RBT+FES or to RBT alone (i.e. without FES). They will complete 18 training sessions over 6 weeks (3 sessions/week). Clinical and biomechanical assessments of balance, strength and proprioception will be completed before training, immediately after training, and six months post-training. Falls will be monitored for six months after training through an online survey and regular phone calls. Performance on clinical and biomechanical measures and fall data will be compared between groups. This research will inform the need for, and design of, a larger RCT, and has the potential to transform fall prevention after iSCI.

This is a phase 1 study of safety and feasibility of cervical spinal cord stimulator implantation in cervical SCI subjects who are ventilator dependent. The Investigators will be focusing on the safety and feasibility of this approach. Participants may qualify for the study if they are male or female 18-75 years old, are at least 1 year after original injury, have injury at C2 to C7 level, and dependent on mechanical ventilation to help them breathe. Additionally, they need to be able to attend up to twice weekly testing sessions for up to 21 months.