WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers. Data are collected during routine care from over 1,400 clinicians across the USA and Puerto Rico using a highly structured certified electronic health record (EHR) or electronic data capture (EDC) system. Data are transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry captures real-time, research-ready data on patient demographics, comorbidities, wound characteristics, standard-of-care treatments, complications, and advanced therapeutics. It supports robust, fit-for-purpose real-world evidence generation by enabling risk-adjusted outcome analysis, comparative effectiveness research, and quality improvement across diverse sites of care.
Diabetic Foot· U.S. Wound Registry· The Woodlands, Texas
RADIANT is a network of 14 clinical sites and several laboratories dedicated to the study of atypical diabetes.
The objective of this study is to define new forms of diabetes and the unique mechanisms underlying these forms of atypical diabetes. The specific aims are to:
1. Identify and enroll individuals and families with undiagnosed rare and atypical forms of diabetes.
2. Determine the etiologic basis of the metabolic disorder among individuals and families with novel forms of rare and atypical diabetes.
3. Understand the pathophysiology of individuals and families with novel forms of rare and atypical forms of diabetes.
Diabetes Mellitus· University of South Florida· Aurora, Colorado · Chicago, Illinois +3 more
The purpose of this clinical study is to look at the safety and tolerability of switching from semaglutide to CagriSema, for participants who have type 2 diabetes. All participants will get CagriSema, the treatment being tested. Participants will be in this clinical study for about 6 months.
Diabetes Mellitus, Type 2· Novo Nordisk A/S· Gilbert, Arizona · Houston, Texas
To elucidate the mechanisms by which type 1 diabetes-associated genes; IFIH1, TYK2, IKZF4, as well as total genetic risk, impart functional immunoregulatory abnormalities that result in expansion of self-reactive adaptive immune cells, defective regulatory/effector mechanisms in T cells, inflammatory antigen presenting cells, and abnormal immune function in T cells and B cells.
Type 1 Diabetes· University of Florida· Gainesville, Florida · Columbus, Ohio +1 more0
This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin.
This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.
Gestational Diabetes Mellitus· Ohio State University· Tuscaloosa, Alabama · Los Angeles, California +3 more
CAPTAIN-T2D will take place in two parts. Part 1 (Screening) will evaluate patients with type 2 diabetes and elevated cortisol risk factors for trial eligibility and the presence of elevated cortisol. Participants deemed eligible from Part 1 will be randomized to either clofutriben or placebo in the double-blind (participant and investigator), dose-ranging, interventional Part 2 (Treatment).
Type 2 Diabetes· Sparrow Pharmaceuticals· Chandler, Arizona · Tucson, Arizona +3 more
This is a Phase 2b, investigator- and participant-blinded, placebo-controlled, parallel-arm study to evaluate the efficacy, safety and tolerability of SAB 142 in patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D).
Type 1 Diabetes· SAb Biotherapeutics, Inc.· San Francisco, California · Aurora, Colorado +3 more· Ages 5–40
This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \<21 with recent-onset stage 3 T1D.
Type 1 Diabetes· City of Hope Medical Center· San Francisco, California · Gainesville, Florida +3 more· Ages 9–20
This study is being done to find better ways to help people with prediabetes prevent or delay the development of type 2 diabetes. Prediabetes means your blood sugar is higher than normal, but not high enough to be diagnosed with diabetes. It is often silent, but without changes in diet and activity, many people progress to a diagnosis of diabetes within a few years.
The study combines two strategies:
1. Group visits - small, regular meetings where patients learn about healthy eating, physical activity, and stress management.
2. Continuous Glucose Monitors (CGMs) - small wearable sensors that measure blood sugar all day and show how food, movement, and sleep affect it in real time.
By bringing these two tools together, the research hopes to help participants better understand their own bodies and make lasting lifestyle changes.
What is the purpose of this research?
The purpose of this research is to find out whether using a CGM device together with group sessions can help people with prediabetes lower their average blood sugar (measured by A1C) and improve confidence in managing their health.
Pre Diabetic· Sam Houston State University· Conroe, Texas· Ages 18–75
This study is being conducted to find out how well zenagamtide works and how safe it is compared to insulin glargine in participants with type 2 diabetes who are at higher risk of heart and blood vessel problems and are already taking 1 to 3 diabetes medications. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide, (the treatment being tested) or insulin glargine (a comparator) and which treatment participants get is decided by chance.
Type 2 Diabetes· Novo Nordisk A/S· Houston, Texas · Sugar Land, Texas
This study is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103. The approximately 393-days study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (275 days).
Type 1 Diabetes Mellitus· COUR Pharmaceutical Development Company, Inc.· Tucson, Arizona · Newport Beach, California +2 more· Ages 12–35
The goal of the DISCOVERY study is to provide innovative critical information regarding the unique natural history of glycemic control, insulin sensitivity, and β-cell function, and their mechanistic determinates, in obese adolescents at risk for developing type 2 diabetes.
Diabetes Mellitus Type 2, Childhood-Onset· George Washington University· Birmingham, Alabama · Phoenix, Arizona +2 more· Ages 8–15
The goal of this clinical trial is to is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. The main question it aims to answer is whether participants who use Walkasins on an everyday basis over a six-month period will report better awareness of their foot placement on the ground.
Researchers will compare Walkasins users to a control group of participants who are not using Walkasins to see if the device improves the users' performance on some standing and walking tests. Control group participants will get Walkasins after six months of being in the study.
During the study participants will be asked to do the following:
* Answer questions about their medical history and balance.
* Do some standing and walking tests. Some of the tests will be timed.
* Attend study visits and participate in study phone calls.
* Keep track of any falls and notify study staff if they fall.
* Wear the Walkasins device on a regular basis.
Peripheral Neuropathies· RxFunction Inc.· Mesa, Arizona · Amherst, New York +2 more
This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.
Diabetes Mellitus, Type 2· Novo Nordisk A/S· Chicago, Illinois · Houston, Texas· Ages 18–75
This is a phase 2 randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes (T2D) not achieving glycemic targets despite Ozempic-based therapy.
Type 2 Diabetes· Biomea Fusion Inc.· Houston, Texas· Ages 18–70
CAMPR-II Trial: A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a saline-hydrated allogeneic dual-layer amniotic membrane product or a synthetic, resorbable polymeric wound matrix to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs
Wound, Foot· Capsicure, LLC· San Diego, California · Coral Gables, Florida +2 more
TRANSFORM is a prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial in patients who are at increased risk for atherosclerotic cardiovascular (CV) disease but with no known symptomatic CV disease. The trial tests the hypothesis that a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy reduces CV events compared with risk factor-based care.
Diabetes Mellitus, Type 2· Cleerly, Inc.· Chandler, Arizona · Scottsdale, Arizona +3 more
Rationale:
The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and characterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. The TrialNet Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been designed to clarify this picture, and in so doing, will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM.
Purpose:
TrialNet is an international network dedicated to the study, prevention, and early treatment of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes.
The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to enhance our understanding of the demographic, immunologic, and metabolic characteristics of individuals at risk for developing type 1 diabetes.
The Natural History Study will screen relatives of people with type 1 diabetes to identify those at risk for developing the disease. Relatives of people with type 1 diabetes have about a 5% percent chance of being positive for the antibodies associated with diabetes. TrialNet will identify adults and children at risk for developing diabetes by testing for the presence of these antibodies in the blood. A positive antibody test is an early indication that damage to insulin-secreting cells may have begun. If this test is positive, additional testing will be offered to determine the likelihood that a person may develop diabetes. Individuals with antibodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes.
Diabetes Mellitus, Type 1· University of South Florida· Orange, California · San Francisco, California +3 more· Ages 2–45
The goal of this prospective study is to determine whether there is superiority of 10 Twizzlers to the 50 gram glucola beverage for screening for GDM in a population based study.
Gestational Diabetes Mellitus· Baylor College of Medicine· Houston, Texas· Ages 18–64