Negative-pressure wound therapy for management of chronic neuropathic noninfected diabetic foot ulcerations – short-term efficacy and long-term outcomes

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.

Negative pressure wound therapy use in diabetic foot syndrome—from mechanisms of action to clinical practice

“…Again, a greater proportion of ulcers treated with NPWT achieved healing than in the comparator treatment group—46.3% vs 32.8% at 20 weeks. Our results based on the meta‐analysis of this American paper and about a dozen of other nonrandomized studies, including our local Krakow observational data, showed an advantage of NPWT therapy in one important outcome—major amputation rate.…”

Surgical Management of Diabetic Neuropathy Foot Complications

“…For a better use of the surgical management arsenal, in our departament was imagined and conceived a therapeutic-prognostic index to help the surgeon establish an adequate procedure (18,19). As an alternative to surgical management for chronic neuropathic nonifected diabetic ulcers, negative pressure wound therapy did not prove its effectiveness over standard therapy, hight rates of recurrence being reported (20). In diabetic foot ulcers patients, the risk of limb amputation depends on severity of infection at the initial presentation, previous history of lower extremity amputation, peripheral arterial disease and presence of any walking disability.…”

Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: a systematic review

“…In total four RCTs, three cohort studies and one case control were found comparing the use of NPWT with standard of care, all of which were at high risk of bias …”

“…The findings from two other cohort‐controlled studies, while indicating apparent benefit, could not be easily interpreted due to unclear statistical analysis, and both were considered at high risk of bias. A recent prospective observational cohort did not report a difference in ulcer healing outcomes at 1 year, but allocation to NPWT if ulcer area was more than 1 cm 2 or to a comparator if less than 1 cm 2 would have introduced significant bias. Moreover, adequate description of the comparator was not provided.…”

“…In total four RCTs, three cohort studies and one case control were found comparing the use of NPWT with standard of care, all of which were at high risk of bias. [66][67][68][69][70][71][72][73] Two early RCTs were very small and poorly scoring but reported significant benefits in both healing rate and healing time. 66,67 One larger RCT also suggested benefit of NPWT over "advanced moist wound therapy" in terms of reduced ulcer area in an outpatient cohort but did not provide a clear description of the statistical basis of the conclusion.…”