Sheffield, Ohio

Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up

The objective of this research protocol is the development of a national Proton Therapy Center Registry for the purpose of: 1. Performing retrospective research studies on diseases treated with proton therapy throughout the United States. 2. Maintaining regular, lifetime contact with subjects in order to obtain current identification , contact information, and self/parent-reported health status in order to obtain a better understanding of overall treatment strategies and patient benefits of treatment. 3. Permitting review of medical record information contained within the Registry to identify subjects who may be eligible for participation in future research studies conducted at the Proton Therapy Institution where the participant was treated. Obtaining the permission of Research Registry participants to be contacted to ascertain their interest in participating in future research studies being conducted at their participating Proton Therapy Institution for which it appears (i.e., based on medical information contained within the Research Registry) they may be eligible.

Registry Study for Radiation Therapy Outcomes

A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers

Hard to heal Chronic wounds affect a significant percentage of patients over their lifetime. For example, diabetic foot ulcers (DFU) are a major health complication that affect up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of hard to heal chronic wounds is extremely challenging as ulcers such as DFUs and Venous Leg Ulcers (VLUs) may not respond to standard of care (SC) treatment and frequently become infected. Advanced wound products like CAMPs have become an important strategy in the treatment of hard-to-heal chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing. The study will evaluate the clinical utility of Multiple CAMPs in the closure of hard to heal diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.