Evaluation of Mesenchymal Stem Cells in the Treatment of Diabetic Foot Ulcers: A Phase I Pilot Study

The primary objective of this study is to evaluate the effect of **mesenchymal stem cells** on the healing of foot ulcers in patients with **diabetic foot ulcus**. This is clinically relevant as diabetic foot ulcers are a common complication in diabetes, often leading to severe outcomes such as infection or amputation. Understanding the potential therapeutic benefits of mesenchymal stem cells could significantly impact treatment strategies and improve patient outcomes.

The clinical trial focuses on individuals diagnosed with **diabetic foot ulcer**. The study population includes both male and female participants, with an age range spanning from 18 to 64 years. Participants are generally in a stable health condition, excluding those considered part of a vulnerable population. The selection process for the trial population is not detailed, and the total number of participants is not provided by the sponsor. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data. Key inclusion or exclusion criteria are also not disclosed.

The clinical trial is designed to evaluate the effect of **mesenchymal stem cells** on the healing of foot ulcers in patients with diabetes. This study is a phase I pilot trial, which is expected to run from December 15, 2022, to August 31, 2025. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. Participants will be randomly assigned to either the treatment group receiving mesenchymal stem cells or a control group. The double-blind nature of the study ensures that neither the participants nor the researchers know which group the participants are in, minimizing bias.

The sequence of study visits begins with an inclusion visit, where potential participants are screened for eligibility based on predefined criteria. This visit is crucial for ensuring that only suitable candidates are enrolled in the trial. Following the inclusion visit, participants will attend regular follow-up visits, which are scheduled to monitor the progress of the treatment and assess any adverse effects. These visits are essential for collecting data on the primary and secondary endpoints of the study. The trial concludes with an end-of-study visit, where final assessments are conducted to evaluate the overall outcomes of the treatment.

The expected length of participant involvement in the study is approximately 33 months, from the initial screening to the end-of-study visit. Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with the study protocol, or withdraw consent. The trial's design and procedures are structured to ensure the safety and well-being of participants while providing valuable insights into the potential therapeutic benefits of mesenchymal stem cells for diabetic foot ulcers.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

The clinical trial will assess efficacy through a structured evaluation process. The trial is scheduled to conclude by August 31, 2025, with recruitment having commenced on December 15, 2022. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, the trial will likely employ standard methodologies appropriate for its phase to measure and analyze outcomes. These may include validated scales, laboratory tests, or patient-reported outcomes, depending on the nature of the intervention and the condition being studied. The trial's design will ensure that data collection and analysis are conducted systematically to provide reliable efficacy results.