Pooled study-level analysis of randomized controlled trials analyzing the effect of negative pressure wound therapy with irrigation vs traditional negative pressure wound therapy on diabetic foot outcomes.

INTRODUCTION: The benefits of NPWT-T for the diabetic foot have been established. The addition of regular periodic irrigation with broad-spectrum antiseptic solution has been shown to reduce bioburden and total bacterial colonies; however, debate remains as to the clinical effect on diabetic foot outcomes. OBJECTIVE: This study investigated the differences between NPWT-T and NPWT-I for treatment of the diabetic foot and the associated clinical outcomes. METHODS: PubMed, Medline/Embase, the Cochrane Library, and Web of Science were searched for relevant literature published between January 1, 2002, and March 1, 2022. Keywords included "Negative Pressure Wound Therapy" AND "Instillation" OR "Irrigation." Three studies with a total of 421 patients (NPWT-T [n = 223], NPWT-I [n = 198]) were included in the meta-analysis. RESULTS: No significant differences were observed between NPWT-T and NPWT-I for BWC (OR, 1.049; 95% CI, 0.709-1.552; P =.810), time to wound closure (SMD, -0.039; 95% CI, -0.233-0.154; P =.691), LOS (SMD, 0.065; 95% CI, -0.128-0.259; P =.508), or AEs (OR, 1.092; 95% CI, 0.714-1.670; P =.69). CONCLUSION: Results of this systematic review and meta-analysis indicate that further RCTs are required to assess the role of NPWT-I in the management of DFU and DFI.

The Effect of Implanted Functional Electrical Stimulation on Gait Performance in Stroke Survivors: A Systematic Review.

The emerging literature suggests that implantable functional electrical stimulation may improve gait performance in stroke survivors. However, there is no review providing the possible therapeutic effects of implanted functional electrical stimulation on gait performance in stroke survivors. We performed a web-based, systematic paper search using PubMed, the Cochrane Library, and EMBASE. We limited the search results to human subjects and papers published in peer-reviewed journals in English. We did not restrict demographic or clinical characteristics. We included 10 papers in the current systematic review. Across all included studies, we found preliminary evidence of the potential therapeutic effects of functional electrical stimulation on walking endurance, walking speed, ankle mobility, and push-off force in stroke survivors. However, due to the heterogeneity between the included studies, small sample size, and lack of randomized controlled trials, more studies are critically needed to confirm whether implanted functional electrical stimulation can improve gait performance in stroke survivors.

Randomized clinical study to compare negative pressure wound therapy with simultaneous saline irrigation and traditional negative pressure wound therapy for complex foot infections.

The aim of this study was to compare the efficacy of different negative pressure wound therapy (NPWT) devices and NPWT with and without simultaneous irrigation in patients admitted to hospital with moderate and severe foot infections. Ninety patients were randomized in a 12-week prospective, randomized noninferiority trial to compare wound healing in patients with moderate and severe infected foot wounds treated with NPWT after surgery. Inclusion criteria included ABI > 0.5 or toe pressures >30 PVR/mmHg, >18 years of age and exclusion included active Charcot arthropathy, collagen vascular disease, HIV, and hypercoagulable state. We compared two different traditional devices, NPWT-K (KCI, VAC Ulta) and NPWT-C (Cardinal, PRO), and NPWT-I with saline irrigation (Cardinal, PRO). All patients had therapy delivered at 125 mmHg continuous pressure. In patients who received simultaneous saline irrigation (NPWT-I), the administration rate was 15 ml per hour. The primary outcome was the proportion of healed wounds in 12 weeks. Secondary outcomes included surgical wound closure, number of surgeries, length of stay, and time to wound healing. Continuous data was presented as mean ± standard deviation. Analysis of variance was used to compare continuous variables and chi-square to compare dichotomous variables with an alpha of 0.05. There were no differences in outcomes among NPWT-I, NPWT-C, and NPWT-K groups in proportion of healed wounds (63.3%, 50.0%, 46.7% p = 0.39), surgical wound closure (83.3%, 80.0%, 63.3%, p = 0.15), number of surgeries (2.0 ± 0.49, 2.4 ± 0.77, 2.4 ± 0.68, p = 0.06), length of stay (16.3 ± 15.7, 14.7 ± 7.4, 15.3 ± 10.5 days, p = 0.87), time to wound healing (46.2 ± 22.8, 40.9 ± 18.8, 45.9 ± 28.3 days, p = 0.78). We did not identify any significant differences in clinical outcomes or adverse events between patients treated with different NPWT devices or NPWT with and without irrigation.

Erbium: Yttrium Aluminum Garnet Laser Accelerates Healing in Indolent Diabetic Foot Ulcers.

The objective of the study was to evaluate the effect of the erbium:yttrium aluminum garnet (YAG) laser on diabetic foot ulcers (DFUs) that had not responded to standard care. We retrospectively evaluated 22 nonhealing DFUs that received at least 4 weeks of standard wound care, demonstrated poor healing response, and subsequently were treated with an erbium:YAG laser. We measured the percent wound area reduction (PWAR) for the 4 weeks before initiating laser therapy and the PWAR for 4 weeks after the initiation of laser therapy. Erbium:YAG laser treatment consisted of 2 components: debridement and resurfacing. The laser settings were the same for all treatments. We used the paired t test to compare pretreatment with posttreatment wound area reduction. During the 4-week period before the initiation of laser therapy, the average PWAR was -33.6%. Four weeks after initiating treatment with the erbium:YAG laser, the average PWAR was 63.4% (p = .002) and 72.7% of wounds had ≥50% PWAR. By 12 weeks, 50% of wounds had healed. Erbium:YAG laser therapy accelerated DFU healing in a cohort of patients with ulcers that had been unresponsive to standard of care therapy.

Using Plantar Electrical Stimulation to Improve Postural Balance and Plantar Sensation Among Patients With Diabetic Peripheral Neuropathy: A Randomized Double Blinded Study.

OBJECTIVE: People with diabetic peripheral neuropathy (DPN) often exhibit deteriorations in motor-performance mainly due to lack of plantar-sensation. The study explored effectiveness of plantar electrical-stimulation therapy to enhance motor-performance among people with DPN. DESIGN AND METHODS: Using a double-blinded model, 28 volunteers with DPN (age: 57.8 ± 10.2 years) were recruited and randomized to either intervention (IG: n = 17) or control (CG: n = 11) group. Both groups received identical plantar-stimulation devices for six weeks of daily use at home; however, only the IG devices were set to deliver stimulation. Balance (ankle, hip, and center of mass [COM] sway) and gait (stride velocity [SV], stride time [ST], stride length [SL], and cadence) were measured using validated wearable sensors. Outcomes were assessed at baseline and at six-week. Clinical assessment including vascular as measured by ankle-brachial-index (ABI) and plantar-sensation as quantified by vibratory plantar threshold (VPT) were also measured at baseline and six weeks. RESULTS: No difference were observed between groups for baseline characteristics ( P > .050). Posttherapy, ankle and COM sway with eyes open were significantly improved ( P < .05, Cohen's effect size d = 0.67-0.76) in the IG with no noticeable changes in CG. All gait parameters were significantly improved in the IG with highest effect size observed for cadence ( d = 1.35, P = .000). Results revealed improvement in VPT ( P = .004, d = 1.15) with significant correlation with stride velocity improvement ( r = .56, P = .037). ABI was improved in the IG in particulate among those with ABI>1.20 ( P = .041, d = 0.99) Conclusion: This study suggests that daily home use of plantar electrical-stimulation may be a practical means to enhance motor-performance and plantar-sensation in people with DPN.

Treatment options for venous leg ulcers: effectiveness of vascular surgery, bioengineered tissue, and electrical stimulation.

OBJECTIVE: To evaluate the peer-reviewed literature that compares advanced venous leg ulcer therapies to standard of care with compression dressings. METHODS: A MEDLINE search for venous ulcer treatment with electrical stimulation, surgical vein correction, and bioengineered tissues was conducted. Randomized clinical trials comparing advanced treatment with standard of care using compression dressing were included. A total of 7 bioengineered tissue, 4 surgical treatment, and 4 electrical stimulation randomized clinical trials were identified. RESULTS: Compared with nonstandard treatments, electrical stimulation demonstrated improved wound healing, fewer adverse events, and shorter duration of healing. Healing rates at the end of the study were greater for surgical intervention, followed by similar outcomes for electrical stimulation and bioengineered tissues. Studies involving bioengineered tissues and surgical venous ablation demonstrated inconsistent/inconclusive results. CONCLUSIONS: Utilization of electrical stimulation in venous ulcer management has not been fully explored. Further studies of dosing electrical stimulation therapy may reveal therapeutic and preventive benefits for managing venous ulcers not yet elucidated.

Does hyperbaric oxygen therapy work in facilitating acute wound healing: a systematic review.

BACKGROUND: Adjunctive hyperbaric oxygen therapy is a safe and effective modality with which to increase tissue oxygenation and aid in healing of difficult wounds. The majority of the literature surrounding hyperbaric oxygen therapy supports its use in chronic wounds, but its use in acute wounds, flaps, and grafts is less well supported. METHODS: The authors reviewed the Ovid, PubMed, and Cochrane Library databases, and selected studies, level III and above, using hyperbaric oxygen therapy in the treatment of complicated acute wounds, flaps, and grafts. RESULTS: A total of eight studies were found to meet criteria for evaluation of adjunctive hyperbaric oxygen therapy in the treatment of complicated acute wounds, flaps, and grafts. CONCLUSIONS: When combined with standard wound management principles, hyperbaric oxygen therapy can augment healing in complicated acute wounds. However, it is not indicated in normal wound management. Further investigation is required before it can be recommended as a mainstay in adjuvant wound therapy. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Electrical stimulation as an adjunctive treatment of painful and sensory diabetic neuropathy.

BACKGROUND: The objective of this review is to evaluate the use of electrical stimulation to treat diabetic neuropathy. Application of electrical stimulation may provide a novel treatment option for large and small fiber neuropathy in persons with diabetes. Large and small nerve neuropathy alters pain, proprioception, touch perception, and motor function, which cause burning foot pain and serve as protective mechanisms from ulcerations. METHODS: A content search for clinical trials involving electrical stimulation, neuropathy, and diabetes was conducted through PubMed. Randomized clinical trials and prospective studies with outcome measures affecting the lower extremity function were selected for review. RESULTS: We identified eight studies in which electrical stimulation was used to treat diabetic neuropathy. Six studies evaluated small fiber neuropathy. Two studies evaluated patients with both small and large fiber neuropathy and reported significant improvement in vibration and monofilament testing and reduction in symptoms in the electrical stimulation treatment group. Six of the eight painful neuropathy studies identified significant improvement in symptoms. There were no studies that evaluated electrical stimulation to treated diabetic motor neuropathy, fall prevention or postural instability. CONCLUSIONS: Electrical stimulation may be an effective alternative and adjunctive therapy to current interventions for diabetic peripheral neuropathy.

The use of pulsed radio frequency energy therapy in treating lower extremity wounds: results of a retrospective study of a wound registry.

Pulsed radio frequency energy (PRFE) has been shown to stimulate cultured epidermal cells in vitro, inciting a cascade of cytokines, cyclins, growth factors, and other gene products associated with wound healing. A retrospective, descriptive study was conducted to evaluate the effect of PRFE on healing lower extremity wounds. Using data from a patient registry of 510 wounds in 413 patients, information was abstracted on patients with lower extremity wounds treated with PRFE for at least 4 weeks between 2005 and 2008 and who were evaluated 4 weeks after the start of treatment; wound size reduction was calculated. Patients with peripheral vascular disease, renal disease, poor glucose control, immune-compromise, large or deep wounds were not excluded. Of the 128 wounds (in 113 patients) that met the eligibility criteria, 35 were diabetic foot ulcers (DFUs), 42 were venous leg ulcers (VLUs), 34 were Stage II to Stage IV pressure ulcers (PUs), and 27 were other types of chronic wounds. Most patients were men (91%), receiving outpatient care (70%), and elderly (mean age 67 ± 11 years, median 64, range 41-89). Mean wound duration before starting PRFE was 29 ± 86 months (median 10, range 1-756). Mean percent reduction in wound area after 4 weeks was 49% ± 6% for pressure (P <0.0001), 38% ± 6% for diabetic (P <0.0001), 44% ± 5% for venous (P <0.0001), and 39% ± 9% for wounds of various other etiologies (P = 0.0001). The median wound reduction rate was 0.08 cm(2)/day (range -4.14-2.21). A considerable percentage of wounds reached >50% reduction in size at 4 weeks (DFU 40%, VLU 43%, PU 59%), suggesting that a large proportion of these PRFE-treated wounds wound have healed with ongoing therapy. Additional studies to evaluate the safety, effectiveness, and efficacy of this treatment modality in the management of chronic wounds are warranted.

Does anodyne light therapy improve peripheral neuropathy in diabetes? A double-blind, sham-controlled, randomized trial to evaluate monochromatic infrared photoenergy.

OBJECTIVE: The purpose of this study was to determine the efficacy of anodyne monochromatic infrared photo energy (MIRE) in-home treatments over a 90-day period to improve peripheral sensation and self-reported quality of life in individuals with diabetes. RESEARCH DESIGN AND METHODS: This was a double-blind, randomized, sham-controlled clinical trail. We randomly assigned 69 individuals with diabetes and a vibration perception threshold (VPT) between 20 and 45 V to two treatment groups: active or sham treatment. Sixty patients (120 limbs) completed the study. Anodyne units were used at home every day for 40 min for 90 days. We evaluated nerve conduction velocities, VPT, Semmes-Weinstein monofilaments (SWM) (4-, 10-, 26-, and 60-g monofilaments), the Michigan Neuropathy Screening Instrument (MNSI), a 10-cm visual analog pain scale, and a neuropathy-specific quality of life instrument. We used a nested repeated-measures multiple ANOVA design. Two sites (great toe and fifth metatarsal) were tested on both the left and right feet of each patient, so two feet were nested within each patient and two sites were nested within each foot. To analyze the ordinal SWM scores, we used a nonparametric factorial analysis for longitudinal data. RESULTS: There were no significant differences in measures for quality of life, MNSI, VPT, SWM, or nerve conduction velocities in active or sham treatment groups (P > 0.05). CONCLUSIONS: Anodyne MIRE therapy was no more effective than sham therapy in the treatment of sensory neuropathy in individuals with diabetes.