Oradell

Researchers are evaluating ELU42, a topical small molecule combining a tankyrase inhibitor with a special hyaluronic acid, to study its safety and early effects on chronic diabetic foot ulcers. This Phase I/IIA open-label study focuses on adults with Wagner grade 1-2 diabetic foot ulcers lasting between 4 and 52 weeks. The study aims to assess how ELU42 affects wound healing and monitors safety through various health measures. Participants will first receive standard wound care for two weeks, including offloading, dressings, and cleaning. Then, ELU42 topical spray will be applied by trained staff to the ulcer three times a week for six weeks, with up to 18 treatments possible. If the wound heals but later reopens, participants may undergo another six-week treatment course. The study includes weekly visits during treatment and follow-ups for up to six weeks, with additional visits if the wound closes to observe healing over three months. During the study, participants will undergo safety evaluations such as blood tests, heart monitoring, and nutritional assessments. Researchers will measure wound healing by tracking the reduction in ulcer area at weeks 4 and 6 using both manual and automated methods. Secondary assessments include complete wound closure, wound hydration, patient-reported outcomes, and drug level monitoring in some participants. The total participation time includes treatment and follow-up periods up to several months.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.