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A Prospective, Open-Label, Randomized, Comparative, Investigator-Initiated Study to Evaluate the Safety and Effectiveness of Autologous Growth Factor Concentrate Using the Healrex Therapy Kit With Standard Wound Care in Lower-Extremity Diabetic Ulcer.
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Background and objectives The persistent nature of diabetic foot ulcers (DFUs) is mainly attributable to compromised wound healing mechanisms, which are aggravated due to poor blood flow, neuropathy, and infection. Growth factors have become essential agents in the treatment of DFUs, serving as primary mediators that enhance wound healing through the stimulation of cell proliferation, migration, and angiogenesis. This prospective open-label, randomised, comparative, multi-centre, investigator-initiated study compared the safety and effectiveness of adjuvant therapy with topical application of autologous growth factor concentrate (AGFC) using the Healrex therapy kit (Wockhardt, India) versus standard of care (SoC) in DFUs.
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