Osteomyelitis

Researchers are studying the use of the TRUMATCH Graft Cage to repair large segmental defects in long bones such as the humerus, femur, and tibia. This observational case series includes patients aged 18 and older who have these critical-sized bone defects requiring surgical fixation. The goal is to collect data over three years to better understand the healing process, complications, and recovery outcomes associated with this device. Participants who agree to join will receive the TRUMATCH Graft Cage during surgery to repair their long bone defects. The study focuses on collecting information about healing rates, complication rates, reoperation rates, pain levels, and the time it takes to return to normal activities. Data collection will occur over two years following the procedure to evaluate early outcomes of using the graft cage. During the study, participants will be monitored regularly to track their healing progress and any complications. Researchers will assess pain scores, need for additional surgeries, and functional recovery. The study will analyze this information after three years of data collection to provide insights on the graft cage's usefulness for managing complex long bone injuries. Participation involves follow-up visits and evaluations related to their surgical repair and recovery.

Researchers are evaluating the progress of chronic wounds, specifically venous leg ulcers (VLU) and diabetic foot ulcers (DFU), using an absorbent dressing called Mepilex Up. This study is a prospective, open, multi-center, interventional trial designed to observe wound healing over a period of up to six weeks. The goal is to track changes in wound area and condition while participants receive treatment according to local standards of care. Participants will use the Mepilex Up dressing, which is a soft, silicone-based absorbent foam dressing designed to manage wound exudate and protect the skin. The dressing will be applied as the primary dressing and changed weekly for up to six weeks or until the wound heals. The study includes seven visits: a baseline visit followed by weekly visits to monitor wound healing and dressing performance. During each visit, researchers will assess wound progress through measurements and evaluations of wound area, volume, tissue quality, exudate, and skin condition. Participants will report on pain, comfort, and quality of life related to wound care. Safety will be monitored at all visits. The total treatment period is a maximum of 44 days or until healing occurs, with detailed tracking of dressing wear time, wound changes, and any adverse events.

Researchers are evaluating the effectiveness of a single layer placental-based allograft combined with standard care for treating nonhealing diabetic foot ulcers. This controlled clinical trial follows a rescue design where patients who do not heal during a previous trial (CAMPX) and were treated only with standard care can enroll to receive the new study product. Participants must meet specific medical criteria related to cellular and matrix-like products as defined by Medicare guidelines. The intervention involves applying the single-layer amniotic membrane product called XWRAP alongside standard care for up to 12 weeks. Patients entering this rescue trial previously failed to heal their ulcers under standard care alone in the CAMPX trial. This study evaluates wound closure and related healing outcomes over this 12-week period. Participants will attend weekly study visits for up to 12 weeks during which researchers will assess wound closure, time to closure, wound size reduction, adverse events, and quality of life related to the wound. Several scales measuring wound impact and pain will also be used. Safety and wound healing progress will be closely monitored throughout the study duration.

This trial focuses on patients with stage IV pressure ulcers complicated by osteomyelitis. It aims to evaluate the safety, tolerability, and the difference in effects between a new treatment called STIMULAN VG combined with debridement and systemic antibiotics, versus the standard care involving debridement and systemic antibiotics alone. The study is a phase II, open-label, randomized, multi-center trial designed to compare these approaches in treating this condition. Participants are randomly assigned to one of two groups: one receives ulcer bursectomy, debridement, insertion of STIMULAN VG into the ulcer cavity, followed by flap or primary closure and peri-operative antibiotics; the other group receives the standard care consisting of ulcer bursectomy, debridement, flap or primary closure, and peri-operative antibiotics without STIMULAN VG. The trial evaluates treatment over an 8-week period post-operation. During the study, participants will undergo assessments to determine individual patient success and clinical outcomes at the 8-week follow-up visit. Researchers will monitor safety and tolerability throughout the trial, with evaluations including imaging to confirm osteomyelitis and clinical status related to wound healing. Participants are expected to comply with scheduled visits, treatment plans, and study procedures for the duration of the trial.

Researchers are gathering detailed real-world information on people with chronic wounds and ulcers to better understand their medical journey and treatment outcomes. This observational registry collects data from over 1,400 healthcare providers across the USA and Puerto Rico using a specialized electronic health record system. It includes all major wound types such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, arterial ulcers, surgical wounds, traumatic wounds, and inflammatory ulcers. Participants receive care as usual from their clinicians, who use standard and advanced wound treatments like specialized dressings, compression therapy, offloading devices, cellular and tissue-based products, negative pressure therapy, ultrasound therapy, topical oxygen, hyperbaric oxygen, growth factors, debridement, and topical antibiotics. Data on treatment practices, wound characteristics, patient health conditions, and complications are collected continuously during routine care. Patients may be followed for over five years to track long-term outcomes. During the study, researchers collect information on patient demographics, wound details, treatment methods, visit frequency, and complications. They monitor healing progress, amputations, deaths, wound recurrence, hospitalizations, and other outcomes. The registry uses a wound healing index to adjust for risk and supports quality improvement and research by linking clinical data with insurance claims for comprehensive analysis. This ongoing effort helps to better understand wound healing and treatment effectiveness in everyday healthcare settings.

This research explores the use of a high-resolution microvessel ultrasound imaging system to observe scarring and monitor wound healing in patients with chronic ulcers. The study aims to see if treatments affect the number of tiny blood vessels and circulation around the wound, focusing on chronic diabetic and venous ulcers. It is an interventional study led by the Mayo Clinic that does not involve drug phases or masking methods. Participants with chronic diabetic and venous ulcers will receive standard wound care including wound debridement and treatment. During the study, they will undergo research-specific microvessel ultrasound examinations to assess microvessel formation and tissue stiffness near the ulcer and in unaffected skin. Additionally, two skin biopsies will be taken to gather more information about the wound and skin tissue. Participants will be evaluated over a period of three months, during which microvessel imaging is the primary outcome being measured. The study includes monitoring wound healing progress through ultrasound and skin biopsy data. Patients will be assessed for blood glucose control, blood supply to the wound, and other clinical indicators to understand the healing process. Safety and wound status will be regularly checked throughout the study duration.

Diabetic foot ulcers (DFUs) are common and can lead to serious complications like major amputation and death. This research aims to develop and test a lifestyle-focused intervention led by occupational therapists to help patients better manage their DFU care. The study primarily seeks to determine if this tailored approach is acceptable and feasible for patients who need offloading treatment as part of comprehensive DFU management. Participants with DFUs requiring offloading treatment will receive up to eight virtual lifestyle-based self-management sessions with a licensed occupational therapist over about eight weeks. This intervention will be co-developed with input from patients, caregivers, family members, and the DFU care team. At the end of the intervention, focus group interviews will be conducted with care team members and therapists to gather feedback on acceptability and feasibility. During the study, participants will complete surveys before and after the intervention to measure patient satisfaction, diabetes distress, and knowledge about offloading. Some will also participate in interviews to discuss their experiences with the intervention. Researchers will monitor DFU-related outcomes for six months after enrollment. Participation involves telemedicine sessions and follow-up assessments, with total intervention lasting approximately eight weeks.

Researchers are evaluating the effect of adding hyperbaric oxygen therapy after lower extremity amputation. The study focuses on patients who have had amputations due to chronic wounds, osteomyelitis, ischemia, or necrosis, conditions commonly associated with poor healing. Hyperbaric oxygen therapy has been used for decades to help heal difficult wounds by increasing oxygen levels in tissues, potentially improving healing at the amputation site and reducing the need for further amputations. Participants who have undergone lower extremity amputation will be randomly assigned to one of two groups. One group will receive 30 sessions of hyperbaric oxygen therapy, each lasting 90 minutes at 2.4 atmosphere absolute (ATA) with 100% oxygen. The first treatment must begin within seven days after amputation, and the therapy is provided as outpatient care after hospital discharge. The other group will receive standard care and outpatient follow-up without hyperbaric oxygen therapy. During the study, participants will be monitored for skin healing at the amputation site up to 12 months, including assessments at 12 weeks, 6 months, 9 months, and 1 year. Researchers will measure outcomes like intact skin without abnormal openings, time to wound closure, reamputations, wound revisions, hospital days, pain levels, quality of life, mobility, and foot and ankle function. Follow-up visits and evaluations will occur regularly to track healing progress and overall health after treatment.

Researchers are developing an artificial intelligence (AI) system to identify key anatomical landmarks during otolaryngological surgeries, such as mastoidectomy and other procedures involving the temporal bone. The goal is to enable real-time tracking of critical structures like the incus and lateral semicircular canal to help surgeons avoid damaging important areas during operations. This observational study focuses on improving surgical safety and precision by using AI technology. The AI system uses annotated data points from surgical videos to recognize and segment the incus, lateral semicircular canal, facial nerve, and facial nerve recess based on their positions relative to surrounding tissues. The model enhances images with contrast adjustment and localized magnification, then classifies and locates these structures continuously during surgery. It also applies statistical analysis to predict the facial recess's location to provide useful guidance for surgeons and improves accuracy through ongoing training. Participants undergoing otolaryngological surgeries with microscope exposure of the temporal bone will have their surgeries recorded and analyzed. The study collects high-resolution temporal bone CT scans and surgical video data to assess the AI model's accuracy. Researchers will monitor relevant indicators of the AI model's performance throughout the study period, as well as during the week from hospital admission to discharge. This study will help evaluate how well AI can assist in identifying important surgical landmarks in real time.

Diabetic foot is a serious complication of diabetes that can lead to ulceration, infection, bone damage, and gangrene, often requiring surgical treatment such as amputation or debridement. This research evaluates the impact of different anesthetic methods, specifically peripheral nerve block (PNB) versus general anesthesia, on outcomes after diabetic foot amputation. The study focuses on inpatient data collected retrospectively from 2021 to 2023 to determine if PNB results in fewer postoperative complications and better recovery. Patients who had amputations of the toe, ankle, or foot under different anesthesia types were included. The study compares PNB, which involves injecting anesthetic near specific nerves under ultrasound guidance, with general anesthesia and other regional anesthetics. Data collected includes patient demographics, preoperative medications, comorbid conditions, surgical details, and anesthesia types. The study reviews major complications such as pneumonia, heart attack, stroke, kidney injury, infections, and re-operations. Outcomes also include mortality within 30 days and the length of hospital stay. Participants' medical records are analyzed for demographic and clinical characteristics, medication use, comorbidities, surgical details, and complications. Statistical methods will assess associations between anesthesia and postoperative outcomes, including survival analysis for hospital stay duration and logistic regression adjusting for confounding factors. The primary measure is 30-day mortality after surgery, with secondary measures of morbidity and hospital discharge timing. This retrospective review is based on existing patient data without altering treatment during the study period.