Abstract
Total contact casting (TCC) is a well-established offloading strategy for the management of Charcot neuroarthropathy and plantar ulcer healing; however, its use after resolution of the acute phase of diabetic foot attack (DFA) remains limited in routine clinical practice, particularly in complex presentations associated with severe infection, edema, compartment syndrome, or necrotizing fasciitis. This study evaluated the role of the San Elian Total Contact Cast (TCC-SE1) as an adjunctive intervention to enhance wound healing during the post-acute phase following clinical remission of DFA. A pilot prospective, comparative, non-randomized observational study was conducted between April 2021 and December 2024, including 67 patients who achieved clinical stabilization after a DFA. Patients received adjunctive treatment with TCC-SE1 or conventional post-acute management. Baseline demographic and clinical characteristics, including the San Elian Wound Severity Score (SEWSS) and DFA type, were comparable between groups (p > 0.05). All patients fulfilled SEWSS criteria for mild-to-severe diabetic foot infection according to IDSA. Mixed DFA—characterized by infection, edema, and/or Charcot neuroarthropathy—were the most frequent type DFA (87%). Severe acute complications, including compartment syndrome and necrotizing fasciitis, required prior surgical control in 97% of cases. Patients with severe unsolved ischemia or high risk of major amputation were excluded. Complete ulcer remission was achieved in 82.3% of patients treated with TCC-SE1 compared with 63.6% in the control group (p = 0.04). Mean healing time was significantly shorter in the TCC-SE1 group, with a reduction of 7.4 weeks (p = 0.03), and final wound area was significantly smaller (mean difference 11.3 cm2, p = 0.04). Kaplan–Meier survival analysis demonstrated a significantly higher probability of earlier wound closure in the TCC-SE1 group compared with conventional management (log-rank p < 0.001). Adjunctive use of TCC-SE1 after remission of complex DFA was associated with improved post-acute wound outcomes; these findings warrant confirmation in larger prospective studies.
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