Safety and Efficacy of Stem Cells for Diabetic Foot Ulcer

Launched by SUPERGENICS LIFE SCIENCE SDN. BHD. · Jan 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of using stem cells to help heal diabetic foot ulcers that are not healing on their own. Specifically, the trial will look at a type of stem cell called Wharton-Jelly mesenchymal stem cells, which will be injected around the ulcer site. The main goals are to see how many patients fully heal their ulcers within six weeks, how long it takes for the ulcers to heal, and whether there are any side effects from the treatment.

To participate in this trial, you must be between 18 and 70 years old, have type 2 diabetes with a specific level of blood sugar control, and have a particular size of ulcer. If you qualify, you will receive either the stem cells or a placebo (a treatment that doesn't contain active ingredients) in multiple injections around your ulcer. After the treatment, you'll have follow-up appointments to check on how well your ulcer is healing. This trial is not yet recruiting participants, but it offers a chance to explore a new treatment option for diabetic foot ulcers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients between 18-70 years old.
• • Patients have type 2 diabetes mellitus
• • Patients with HbA1c, less than or equal to 10%.
• • Patients who were presented with an ulcer size between 8 to 12 cm2, have been diagnosed as full-thickness DFU.
• • Adequate vascular perfusion (ABI ≥ 0.7 and \< 1.3)
• • Patients who are able and willing to provide consent and agree to comply with study procedures and follow-up evaluations.
• Exclusion Criteria:
• • Patients who are not diabetic.
• • Patients with 2 or more ulcers.
• • Patients with a history of participating in another stem cells trial or therapy within 3 months.
• • Patients who are unsuitable to participate the clinical trial as determined by Investigators.