Abstract
PurposeNegative pressure wound therapy (NPWT) is an adjunct method used in the treatment of diabetic foot ulceration (DFU). Real world data on its effectiveness and safety is scarce. In this prospective observational study, we assessed the short-term efficacy, safety, and long-term outcomes of NPWT in patients with type 2 diabetes (T2DM) and neuropathic, noninfected DFUs.MethodsBased on wound characteristics, mainly area (>1 vs. ≤1 cm2), 75 patients with DFUs treated in an outpatient clinic were assigned to NPWT (n = 53) or standard therapy (n = 22). Wound area reduction was evaluated after 8 ± 1 days. Long-term outcomes assessed included complete ulceration closure and recurrence rate.ResultsPatients assigned to NPWT were characterized by greater wound area (15.7 vs. 2.9 cm2). Reduction in wound area was found in both the NPWT (−1.1 cm2, −10.2%, p = 0.0001) and comparator group (−0.3 cm2, −18.0%, p = 0.0038). No serious adverse events related to NPWT were noted. Within 1 year, 55.1% (27/49) of DFUs were closed in the NPWT group and 73.7% (14/19) in the comparator group (p = 0.15). In the logistic regression, wound duration and smaller initial area, but not treatment mode, were associated with closure. One-year follow-up after DFU resolution revealed an ~30.0% recurrence rate in both groups (p = 0.88).ConclusionsNPWT is a safe treatment for neuropathic, nonischemic, and noninfected DFU in patients with T2DM, although this observational study did not prove its effectiveness over standard therapy. Additionally, we report a high rate of both closure and recurrence of ulcers, the latter irrespective of initial ulcer area.
Highlights
These authors contributed : Borys S, Hohendorff JLife expectancy in people with diabetes mellitus, the type 2 form of the disease, is shorter compared to the general population [1]
There were 53 patients assigned to the Negative pressure wound therapy (NPWT) group and 22 to the comparator group
Most of patients were assigned to the comparator group based on the wound area, rather than other criteria
Summary
Life expectancy in people with diabetes mellitus, the type 2 form of the disease, is shorter compared to the general population [1]. This is mainly attributable to its chronic complications, such as coronary artery disease, stroke, and renal failure. Diabetic foot syndrome (DFS), frequently occurring together with ulceration, is another prominent complication. DFS is associated with a high rate of hospitalizations and a 20-fold increase in the risk of lower limb amputations [3, 4]. Foot ulcers precede more than 80% of nontraumatic lower extremity amputations in patients with diabetes [5, 6]. DFS is associated with increased mortality [7, 8]
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