Chinese University of Hong Kong
Samuel KK Ling
TTT is a novel surgical technique that may potentially solve the long-standing deficit of seeking effective treatment for diabetic foot ulcers, decreasing the need for amputations and softening the socio-economic impact it brings. This trial will be the world's first prospective RCT to verify the promising clinical studies on the clinical benefit of TTT in treating diabetic foot ulcers. In addition, blood samples from this study will allow us to study the various systemic circulating soluble factors in relation to neovascularisation, immunomodulation, and stem cell mobilisation. By taking the blood and various time points, we will better understand the complex interplay between various biomarkers. This GRF will allow us to obtain tissue samples to analyse the histological cellular changes after TTT surgery. It will provide us with more insight on how TTT works, as well as potentially helping us pinpoint the important changes and timeframes related to this intervention. The PI, Co-Is and collaborators create a strong team of clinicians and scientists with a solid clinical and basic science track record. The team has published guidelines and surgical techniques in TTT and run several training cadaveric workshops teaching the TTT surgical technique to local orthopaedic surgeons. The team has also established a rat TTT model and published on TTT immunomodulation and neovascularisation in addition to other ongoing mechanistic experiments in animals. This prospective multi-centre randomised controlled trial may act as the foundation for launching this cost-effective TTT surgery to regulate neovascularisation, neurogenesis, immunomodulation and mobilisation of MSCs for the treatment of various chronic conditions. Regenerative medicine is a multi-million dollar industry, and the potential use of TTT can result in a range of clinical applications not limited to DFUs.
Diabetic Foot Ulcer
Transverse Tibial Transport (TTT)
Conventional
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 54 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Clinical and Mechanistic Study of Transverse Tibial Transport in Complex Foot Ulcers |
Actual Study Start Date : | December 1, 2023 |
Estimated Primary Completion Date : | January 31, 2026 |
Estimated Study Completion Date : | January 31, 2026 |
Arm | Intervention/treatment |
---|---|
Other: Control Group Conventional Treatment: Dressing + Negative Pressure Wound Therapy |
Procedure: Conventional |
Experimental: TTT Group Dressing + Negative Pressure Wound Therapy + Transverse Tibial Transport |
Procedure: Transverse Tibial Transport (TTT) |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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