Adipose Tissue Treatment for Diabetic Foot Ulcers

This trial tests a new treatment for diabetic foot ulcers using a system called the SyntrFuge. Researchers aim to determine if injecting tiny pieces of fat processed by this system, known as Autologous Microsized Adipose Tissue Therapy, can accelerate wound healing compared to standard care. Participants will be randomly assigned to either the new fat-based treatment or standard treatment. Individuals with diabetic foot ulcers on the pad or heel of their foot who can walk might be suitable for this trial.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance healing for diabetic foot ulcers.

Research has shown that using the SyntrFuge System to process fat from a patient's own body is safe. Studies have found that this technology, which utilizes body fat, is well-tolerated by patients. For example, when applied to diabetic foot ulcers, it proved effective without major side effects. In fact, using body fat in this manner is considered a safe procedure that aids wound healing and reduces pain. This method has also been applied to conditions like knee osteoarthritis, with no major safety issues reported. This evidence suggests that the SyntrFuge System is a reliable option for treating diabetic foot ulcers.¹²³⁴⁵

Unlike the standard treatment for diabetic foot ulcers, which typically involves debridement and protective footwear like a Camboot, the SyntrFuge System introduces a novel approach using microfragmented adipose tissue injections. This method harnesses the body's own fat tissue, processed into small, injectable units, to potentially enhance healing. Researchers are excited about this treatment because it could stimulate tissue repair and reduce inflammation more effectively than current options. By using the body’s natural resources, there's hope for quicker recovery and fewer complications, making it a promising advancement in managing diabetic foot ulcers.

Research has shown that fat tissue processed with the SyntrFuge™ system, which participants in this trial may receive, may aid in healing diabetic foot ulcers. In one study, 80% of feet treated with this special fat tissue healed within six months, compared to only 46% in the group without this treatment. Another study found that wounds shrank by 75.7% after four weeks in the treatment group, significantly better than the 33.5% reduction in the control group. These results suggest that this method can accelerate wound healing. Additionally, treatments using fat tissue are known to speed up healing, reduce pain, and increase patient satisfaction.¹²³⁴⁵