New Clinical Trial Offers Hope for Treating Diabetic Foot Ulcers with Placental Tissue Therapy

Introduction to Diabetic Foot Ulcers

Diabetic foot ulcers (DFUs) are a common and serious complication faced by individuals with diabetes. According to statistics, around 1.6 million patients in the United States develop DFUs annually. These sores often recur and can lead to severe complications like infections, osteomyelitis, and even amputations if not managed effectively.

The Importance of Early Treatment

Quick and effective treatment of DFUs is crucial. Open ulcers are at a higher risk of leading to life-threatening conditions such as sepsis and can significantly impact a patient’s quality of life. Unfortunately, even with advanced treatments, less than 50% of DFUs heal within 12 weeks. This highlights the urgent need for better treatment options.

StimLabs and the CAMPSTIM Trial

StimLabs, a pioneering company in regenerative medicine, has recently received Institutional Review Board (IRB) approval for their new CAMPSTIM clinical trial. This study aims to assess the effectiveness of their placental-based tissue products in treating DFUs that are difficult to heal. The trial will be conducted across multiple centers and is one of the most extensive of its kind ever to be conducted in the United States.

Innovative Study Design

According to Dr. Thomas E. Serena, the principal investigator, this trial is groundbreaking in several ways. It's the first in the US to use a master trial design to evaluate multiple products within a single study. Additionally, it will employ continuous glucose monitoring, a first for DFU studies, to ensure that blood sugar levels are closely tracked throughout the trial.

Advanced Technologies and Standardized Protocols

The CAMPSTIM trial will utilize state-of-the-art digital devices to measure wound size and bacterial load, ensuring data consistency across different study sites. Furthermore, every patient will use continuous glucose monitoring devices, standardizing patient care and improving data quality.

Comparison of Products

The trial will compare four StimLabs placental-based treatments—Enverse®, Revita®, Relese®, and Cogenex®—against standard care treatments. The goal is to determine whether these advanced therapies significantly improve healing rates and reduce complications in patients with non-healing DFUs.

Primary and Secondary Endpoints

The main focus of the trial will be on the percentage of ulcers that achieve complete wound closure within 12 weeks. Secondary measures will include the time taken to close the wound, reduction in wound size, number of adverse events, and overall changes in pain and quality of life for the patients involved.

Technological Advancements

The CAMPSTIM trial also employs StimLabs' patented Clearify® technology. This innovative approach retains all three layers of the placental membrane—amnion, chorion, and intermediate layer—intact. This ensures that the essential structural proteins and growth factors remain in place, increasing the likelihood of successful wound healing.

Impact on Patient Care

John Daniel, Founder and CEO of StimLabs, emphasized that this trial will provide critical data that could transform the care of patients suffering from difficult-to-treat DFUs. The use of high-quality products and advanced technologies offers great promise for improved healing outcomes.

About StimLabs and Mölnlycke

StimLabs is committed to advancing regenerative medicine, particularly in wound care. They offer a range of innovative product solutions and hold a robust intellectual property portfolio. Mölnlycke Health Care, a globally recognized MedTech company, provides critical dressing components for the trial, further enhancing the quality of patient care.