A Design of Experiments Approach to Identify Critical Processing Parameters for Manufacture of an Autologous Platelet Gel for Diabetic Foot Ulcer.

ABSTRACT: Background/Objectives: RAPID^TM Biodynamic Haematogel is a platelet-based gel for wound healing in diabetic foot ulcers. This study aimed to identify the processing parameters that impact on the quality of this autologous point-of-care manufactured product. Methods: An innovative design of experiments (DOE) approach utilizing a split-plot factorial design and linear mixed-effects models enabled the evaluation of six processing parameters on time to gel and the exudation of gel releasate. Results: Across all manufacturing conditions, time to gel was 181.3 ± 179.2 s (n = 28) and the total mass of releasate exuded in 2 h was 5.6 ± 2.1 g (n = 28). Two processing parameters (temperature 15-30 °C and pre-mixing of ascorbic acid and L-PRP) had a significant impact o

SUBMITTER: Olszewska A 

PROVIDER: S-EPMC12655297 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature