1. Efficacy and safety of autologous whole blood clot in diabetic foot ulcers: a randomised controlled trial
- Author
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Snyder, Robert, Nouvong, Aksone, Ulloa, Jesus, Wahab, Naz, Treadwell, Terry, Bruwer, Febe, Naude, Liezl, McGuire, James, Reyzelman, Alexander M, Graham, Timothy, Team:, AWBC Research, Lessing, Rene, Lullove, Eric, Ozker, Emre, Pham, Hau T, Pasternac, Michael, and Cohen, Shira
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Research ,Clinical Trials and Supportive Activities ,Diabetes ,Humans ,Diabetic Foot ,Male ,Female ,Middle Aged ,Wound Healing ,Prospective Studies ,Aged ,Turkey ,South Africa ,Treatment Outcome ,United States ,Blood Transfusion ,Autologous ,AWBC Research Team: ,autologous ,blood ,cell-based therapy ,diabetic ,foot ulcer ,randomised controlled trial ,tissue-based therapy ,wound ,wound care ,wound dressing ,wound healing ,Nursing ,Clinical sciences - Abstract
ObjectiveDiabetic foot ulcers (DFUs) present a significant global health challenge, resulting in high morbidity and economic costs. Current available treatments often fail to achieve satisfactory healing rates, highlighting the need for novel therapies. This study evaluated the safety and efficacy of a novel autologous whole blood clot (AWBC)-a blood-based, biodegradable provisional matrix-in conjunction with standard of care (SoC) when compared to SoC alone in the treatment of hard-to-heal DFUs.MethodA multicentre, prospective, blinded assessor, randomised controlled trial was conducted at 16 sites across the US, South Africa and Turkey. A cohort of patients with hard-to-heal DFUs was enrolled and randomised to either the AWBC group or the control group. The primary endpoint was complete wound closure at 12 weeks, while secondary endpoints included time to heal and percentage area reduction (PAR) at four and eight weeks. Data were analysed using both intention-to-treat (ITT) and per-protocol (PP) populations.ResultsThe cohort included 119 patients. AWBC treatment resulted in a significantly higher healing rate compared to the control in both ITT (41% versus 15%, respectively; p=0.002) and PP populations (51% versus 18%, respectively; p=0.0075). AWBC treatment also resulted in a shorter mean time to heal and higher durability of wound closure. Safety analysis showed a similar incidence of adverse events (AEs) between groups, with no device-related AEs.ConclusionThe AWBC system, by modulating the wound microenvironment and providing a functional extracellular matrix, offered a promising new approach to treating hard-to-heal DFUs, demonstrating superior healing outcomes compared to SoC alone in this study.
- Published
- 2024