Abstract
No study has investigated the role of induced membrane (IM) formation in treating diabetic foot ulcer (DFU). This retrospective study was aimed (1) at evaluating the potential role of a two-staged surgical approach, comprising polymethylmethacrylate (PMMA) implantation and IM formation, in the treatment of DFU and (2) at comparing the results of those with routine wound debridement in patients with DFUs and nonrevascularized peripheral arterial disease (PAD). Fifty patients with infected DFUs who were not candidates for vascular interventions were enrolled between February 2016 and April 2018 and assigned to the PMMA group (n = 28) and conventional group (n = 22). The healing rate, major amputation rate, duration of healing, frequency of debridement procedures, patient survival rate, and reulceration of DFUs were determined. The Mann-Whitney U test, independent sample t-test, and χ2 or Fisher exact test were used in statistical analysis. Overall clinical outcomes were statistically different between the groups (Z = −2.495, P = 0.013). In the PMMA group, 16 patients (57.1%) with intact IM formation achieved ulceration healing at 13.1 ± 3.7 weeks with a mean number of debridements of 1.3 ± 0.4, which were significantly different compared to those values in 5 patients of the conventional group (22.7%, P = 0.014; healing duration: 26.4 ± 7.8 weeks, P = 0.016; mean number of debridements: 3.6 ± 0.5, P ≤ 0.001). At a mean 16.8 ± 4.3-month follow-up, patient survival rates were 92.9% and 68.2% in the PMMA and conventional groups, respectively (P = 0.032). The major amputation rate and reulceration of DFUs were similar between the groups. The two-staged surgical approach is an available, effective modality for improving healing of DFUs. This study provides preliminary information of IM formation followed by PMMA implantation in the management of DFUs in PAD when revascularization is not feasible.
Highlights
Diabetic foot ulcer (DFU) is one of the most feared complications with a lifetime incidence of 15-25% in patients with diabetes mellitus [1, 2]
The conventional group included patients who were treated with regular wound debridement, and the PMMA group included those receiving a two-staged approach comprising PMMA implantation and induced membrane (IM) formation
Patients were of older age (68:4 ± 8:3 years), predominantly male (68.0%), and with a long duration of diabetes (98:1 ± 50:7 months) and severe limb ischemia (ABI: 0:57 ± 0:09)
Summary
Diabetic foot ulcer (DFU) is one of the most feared complications with a lifetime incidence of 15-25% in patients with diabetes mellitus [1, 2]. Arterial insufficiency in the foot resulting from PAD substantially compromises the healing process of DFUs and independently increases the risk of infection, amputation, and mortality [4, 5]. Since PAD is associated with a notably poor prognosis, guidelines from diabetic and vascular societies recommend revascularization by either surgical bypass or endovascular therapy when a major amputation is under consideration in patients with an infected and hard-to-heal DFU because of PAD [10,11,12,13]. Dedicated management of limb ischemia has resulted in a decreased number of major amputations, it should be noted that up to one-third of patients with PAD are not suitable for revascularization surgery because of unfavorable vascular involvement, technical difficulty, or patient refusal. Major amputation is often considered the ultimate solution if an infected DFU causes significant morbidity or threatens the survival of the patient [10, 17]
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