Early experience with venous arterialization for limb salvage in no-option patients with chronic limb-threatening ischemia.

OBJECTIVE: Chronic limb-threatening ischemia (CLTI) is associated with adverse limb outcomes and increased mortality. However, a small subset of the CLTI population will have no feasible conventional methods of revascularization. In such cases, venous arterialization (VA) could provide an alternative for limb salvage. The objective of the present study was to review the outcomes of VA at our institution. METHODS: We performed a single-institution review of 41 patients who had been followed up prospectively and had undergone either superficial or deep VA. The data collected included patient demographics, comorbidities, VA technique (endovascular vs hybrid), and WIfI (wound, ischemia, and foot infection) limb staging. Data were collected at 1-month, 6-month, and 1-year intervals and included the following outcomes: patency, wound healing, major adverse limb events, major amputation, and death. Descriptive statistics were used for analysis. RESULTS: The study group included 41 patients who had undergone successful open hybrid superficial or deep endovascular VA; 21 (51.2%) had undergone a purely endovascular procedure and 20 (48.8%), hybrid VA. The WIfI clinical stage was as follows: stage 4, 33 (80.5%); stage 3, 6 (14.6%); and stage 2, 1 (2.4%). Of the 41 patients, 24 (58.5%) had completed follow-up at 6 months and 16 (39%) at 1 year. At 1 year, the VA primary patency was 28.6% (95% confidence interval [CI], 0.15%-0.43%), primary assisted patency was 44.3% (95% CI, 0.27%-0.60%), and secondary patency was 67% (95% CI, 0.49%-0.80%). The complete wound healing rate was 2.7% (n = 1) at 1 month, 62.5% (n = 15) at 6 months, and 18.8% (n = 3) at 1 year. Overall wound healing at 1 year was 46.3% (n = 19). The number of major adverse limb events at 1 year was 15 (36.5%) and included 8 reinterventions (19.5%) and 7 major amputations (17%). The number of deaths was zero (0%) at 1 month and four (19%) at 6 months. Two deaths (9.5%) were attributed to COVID-19 (coronavirus disease 2019). No further deaths had occurred within 1 year. The limb salvage survival probability at 1 year was 81%. CONCLUSIONS: These findings suggest that for a select subset of CLTI patients presenting with a high WIfI clinical limb stage and no viable options for conventional open or endovascular arterial revascularization, superficial and deep VA are feasible options to achieve limb salvage.

Guillotine Transmetatarsal Amputations With Staged Closure Promote Early Ambulation and Limb Salvage in Patients With Advanced Chronic Limb-Threatening Ischemia.

PURPOSE: Transmetatarsal amputation (TMA) with primary closure has long been an option for limb salvage in patients with advanced chronic limb-threatening ischemia (CLTI) with extensive tissue loss of the forefoot. However, TMA healing and closure techniques are challenging, specifically in high-risk patients. Guillotine transmetatarsal amputations (gTMA) with staged closure may provide an alternative treatment in this population. We report long-term outcomes of such technique. MATERIALS AND METHODS: A single-center retrospective cohort study of CLTI patients undergoing gTMA between 2017 and 2020 was performed. Limb salvage, wound healing, and survival rates were quantified using Kaplan-Meier (KM) analysis. Multivariate regression was used to identify the effect of patient characteristics on the outcomes. RESULTS: Forty-four gTMA procedures were reviewed. Median follow-up was 381 (interquartile range [IQR], 212-539.75) days. After gTMA, 87.8% (n=36) of the patients were able to ambulate after a median interval of 2 (IQR, 1-3) days. Eventual coverage was achieved in a personalized and staged approach by using a combination of skin substitutes (88.6%, n=39) ± split thickness skin grafts (STSG, 61.4%, n=27). KM estimates for limb salvage, wound healing, and survival were 84.1%, 54.5%, and 88.6% at 1 year and 81.8%, 63.8%, and 84.1% at 2 years. Wound healing was significantly associated with STSG application (p=0.002, OR=16.5, 95% CI 2.87-94.81). CONCLUSION: gTMA resulted in high limb salvage rates during long-term follow-up in CLTI patients. Adjunctive STSG placement may enhance wound healing at the gTMA site, thus leading to expedited wound closure. Surgeons may consider gTMA as an alternative to reduce limb loss in CLTI patients at high risk of major amputation. CLINICAL IMPACT: Currently, the clinical presentation of CLTI is becoming more complex to deal with due to the increasing comorbidities as the society becomes older. The data shown in this article means for clinicians that when facing diffused forefoot gangrene and extensive tissue loss, limb preservation could still be considered instead of major amputation. Guillotine transmetatarsal amputations in the setting of an aggressive multidisciplinary group, can be healed by the responsibly utilization of dermal substitutes and skin grafts leading to the preservation of the extremity, allowing mobility, avoiding of sarcopenia, and decreasing frailty. This will equate to maintenance of independent living and preservation of lifespan.

Retrospective real-world comparative effectiveness of ovine forestomach matrix and collagen/ORC in the treatment of diabetic foot ulcers.

The retrospective pragmatic real-world data (RWD) study compared the healing outcomes of diabetic foot ulcers (DFUs) treated with either ovine forestomach matrix (OFM) (n = 1150) or collagen/oxidised regenerated cellulose (ORC) (n = 1072) in out-patient wound care centres. Median time to wound closure was significantly (P = .0015) faster in the OFM group (14.6 ± 0.5 weeks) relative to the collagen/ORC group (16.4 ± 0.7). A sub-group analysis was performed to understand the relative efficacy in DFUs requiring longer periods of treatment and showed that DFUs treated with OFM healed up to 5.3 weeks faster in these challenging wounds. The percentage of wounds closed at 36 weeks was significantly improved in OFM treated DFUs relative to the collagen/ORC. A Cox proportional hazards analysis showed OFM-treated wounds had a 18% greater probability of healing versus wounds managed with collagen/ORC, and the probability increased to 21% when the analysis was adjusted for multiple variables. This study represents the first large retrospective RWD analysis comparing OFM and collagen/ORC and supports the clinical efficacy of OFM in the treatment of DFUs.

Effectiveness of Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses on Balance, Fear of Falling, and Physical Activity in Older Adults: A Randomized Controlled Trial.

BACKGROUND: Foot problems are prevalent in older adults, which may increase the risk and concern for falls. Ankle-foot orthoses (AFO) have been shown to be effective in the stabilization of lower extremities, but their long-term effectiveness in improving balance and their potential to encourage older adults to become more physically active are still debated. OBJECTIVE: This randomized controlled trial investigated the effectiveness of daily use of a custom-made AFO on balance, fear of falling, and physical activity in older adults. STUDY DESIGN: Forty-four older adults with concern about or at risk for falling were randomly allocated to either the control group (CG; 77.3% female, age 75.6 ± 6.5 years, BMI 29.3 ± 6.4) or the intervention group (IG; 63.6% female, age 73.7 ± 6.3 years, BMI = 27.8 ± 4.8). The IG received walking shoes and bilateral custom-made AFO. The CG received only walking shoes. At the baseline and 6-month follow-ups, balance and physical activity were assessed using validated wearable instrumentation and fear of falling was assessed using the Fall Efficacy Scale-International (FES-I). Adherence and acceptability toward wearing the AFO were assessed using self-reported questionnaires at the 6-month follow-up. RESULTS: No significant between-group difference was observed at baseline (p = 0.144-0.882). Compared to baseline and the CG, hip, ankle, and center-of-mass (COM) sways were significantly reduced at the 6-month follow-up in the IG while standing with the feet together during the eyes-open condition (p = 0.005-0.040). Within the IG, the FES-I was reduced significantly (p = 0.036) and there was an increasing trend in the number of walking bouts with a medium effect size (d = 0.52, p = 0.440) compared to baseline. However, there were no significant changes in FES-I and physical activity measures in the CG (p = 0.122-0.894). The reduction in COM sway in the IG was moderately correlated with adherence (r = -0.484, p = 0.047) and strongly correlated with baseline COM sway (r = -0.903, p < 0.001). CONCLUSION: Results suggest that bilateral custom-made AFO plus walking shoes is effective in improving balance compared to walking shoes alone, and it significantly reduces the fear of falling, with a nonsignificant but noticeable positive trend in physical activity, compared to baseline. The results also suggest that older adults with poor balance at baseline and higher daily adherence to using the AFO will gain more benefit from the AFO intervention.

Home-Based Electrical Stimulation to Accelerate Wound Healing-A Double-Blinded Randomized Control Trial.

BACKGROUND: Electrical stimulation (E-Stim) may offer a unique adjunctive treatment to heal complicated diabetic foot ulcers (DFU). Our primary goal is to examine the effectiveness of daily home-based E-Stim therapy to speed-up wound healing. METHODS: Patients with chronic DFUs and mild to severe peripheral arterial disease (PAD) were recruited and randomized to either control (CG) or intervention (IG) groups. The IG received 1-hour home-based E-Stim therapy on daily basis for 4 weeks (4W). E-Stim was delivered through electrical pads placed above the ankle joint using a bio-electric stimulation technology (BEST®) platform (Tennant Biomodulator® PRO). The CG was provided with an identical but non-functional device for the same period. The primary outcome included wound area reduction at 4W from baseline (BL). RESULTS: Thirty-eight patients were recruited and 5 were removed due to non-compliance or infection, leaving 33 participants (IG, n = 16; CG, n =17). At 4W, the IG showed a significant wound area reduction of 22% (BL: 7.4 ± 8.5 cm2 vs 4W: 5.8 ± 8.0 cm2, P = 0.002). Average of wound area was unchanged in the CG (P = 0.982). The self-report adherence to daily home-therapy was 93.9%. CONCLUSIONS: Daily home-based E-Stim provides early results on the feasibility, acceptability, and effectiveness of E-Stim as an adjunctive therapy to speed up wound healings in patients with chronic DFU and mild to severe PAD.

Comparison of initial hemodynamic response after endovascular therapy and open surgical bypass in patients with diabetes mellitus and critical limb ischemia.

BACKGROUND: While endovascular (ENDO) therapy has increasingly become the initial intervention of choice to treat lower extremity peripheral arterial disease, reported outcomes for ENDO in patients with critical limb ischemia (CLI) and diabetes have been reported to be inferior compared to open bypass surgery (OPEN). Objective data assessing the hemodynamic success of ENDO compared to the established benchmark of OPEN are sparse. We therefore evaluated and compared early hemodynamic outcomes of ENDO and OPEN in patients with diabetes with CLI at a single academic center. METHODS: We studied 85 consecutive patients with diabetes and CLI who underwent 109 interventions, either ENDO (n = 78) or OPEN (n = 31). The mean patient age was 69 years; 62% were men. All patients presented with either rest pain and/or ulcer/gangrene. Per protocol, all were assessed using ankle brachial index (ABI) and toe pressure (TP) determinations before and early postintervention. RESULTS: Both ENDO (ΔABI = 0.36 ± 0.24, P < .0001; ΔTP = 35.6 ± 24.1, P < .0001) and OPEN (ΔABI = 0.39 ± 0.17, P < .0001; ΔTP = 34.3 ± 24.0, P < .0001) resulted in significant hemodynamic improvement. There was no statistically significant initial difference between the two types of intervention (ABI, P = .6; TP, P = .6). CONCLUSIONS: These data suggest that with appropriate patient selection, each intervention is similarly efficacious in initially improving hemodynamics. If the intermediate or long-term results of ENDO for CLI in people with diabetes are inferior, the problem is not one of initial hemodynamic response, but more likely due to differing patient characteristics or durability of the intervention.

The impact and outcomes of establishing an integrated interdisciplinary surgical team to care for the diabetic foot.

OBJECTIVE: This study aimed to quantify the impact of an integrated diabetic foot surgical service on outcomes and changes in surgical volume and focus. METHODS: We abstracted registry data from 48 consecutive months at a single institution, evaluating all patients with diabetic foot complications requiring surgery or vascular intervention, and compared outcomes in the 24 months before and after integrating podiatric surgery with vascular surgical limb-salvage service. RESULTS: The service performed 2923 operations; 790 (27.0%) were related to treatment of diabetic foot complications in 374 patients. Of these, 502 were classified as non-vascular diabetic foot surgery and 288 were vascular interventions. Urgent surgery was significantly reduced after team implementation (77.7% vs 48.5%, p < 0.0001; OR = 3.7, 95% CI: 2.4-5.5). The high/low amputation ratio decreased from 0.35 to 0.27 due to an increase in low-level (midfoot) amputations (8.2% vs 26.1%, p < 0.0001; OR = 4.0, 95% CI: 2.0-83.3). A 45.7% reduction in below-knee amputations was realized with a stable above-knee/below-knee amputation ratio (0.73-0.81). One-third of patients required vascular intervention. Vascular reconstructions increased 44.1% following institution of the team. Initial revascularization was endovascular in 70.6% of patients. Repeat endovascular intervention or conversion to open bypass was required in 37.1% of these patients, almost double the reintervention rate of those receiving open bypass first (18.9%). CONCLUSIONS: Interdisciplinary diabetic foot surgery teams may significantly impact surgery type, with greater focus on proactive and preventive, rather than reactive and ablative, procedures. Although endovascular limb-sparing procedures have become increasingly applicable, open bypass remains critical to success.

The Application of Digital Frailty Screening to Triage Nonhealing and Complex Wounds.

OBJECTIVE: We investigated the association between the complexity of diabetic foot ulcers (DFUs) and frailty. RESEARCH DESIGN AND METHODS: Individuals (n = 38) with Grade 2 Wagner DFU were classified into 3 groups based on the Society for Vascular Surgery risk-stratification for major limb amputation as Stage 1 at very low risk (n = 19), Stage 2 at low risk (n = 9), and Stage 3 to 4 at moderate-to-high risk (n = 10) of major limb amputation. Frailty status was objectively assessed using a validated digital frailty meter (FM). The FM works by quantifying weakness, slowness, rigidity, and exhaustion over a 20-second repetitive elbow flexion-extension exercise using a wrist-worn sensor. FM generates a frailty index (FI) ranging from 0 to 1; higher values indicate progressively greater severity of frailty. Skin perfusion pressure (SPP), albumin, and tissue oxygenation level (SatO2) were also measured. One-way analysis of variance (ANOVA) was used to identify group effect for wound complexity. Pearson's correlation coefficient was used to assess the associations with frailty and clinical endpoints. RESULTS: Frailty index was higher in Stage 3 and 4 as compared to Stage 1 (d = 1.4, P < .01) and Stage 2 (d = 1.2, P < .01). Among assessed frailty phenotypes, exhaustion was correlated with SPP (r = -0.63, P < .01) and albumin (r = -0.5, P < .01). CONCLUSION: Digital biomarkers of frailty may predict complexity of DFU and thus triage individuals who can be treated more simply in their primary clinic versus higher risk patients who require prompt referral to multidisciplinary, more complex care.

Effectiveness of Lower-Extremity Electrical Stimulation to Improve Skin Perfusion.

Background: Although numerous studies suggest the benefit of electrical stimulation (E-Stim) therapy to accelerate wound healing, the underlying mechanism of action is still debated. In this pilot study, we examined the potential effectiveness of lower-extremity E-Stim therapy to improve tissue perfusion in patients with diabetic foot ulcers. Methods: Thirty-eight patients with diabetic foot ulcers underwent 60 min of active E-Stim therapy on acupuncture points above the level of the ankle joint using a bioelectric stimulation technology platform. Perfusion changes in response to E-Stim were assessed by measuring skin perfusion pressure (SPP) at baseline and during 30 and 60 min of therapy; retention was assessed 10 min after therapy. Tissue oxygen saturation (SatO2) was measured using a noninvasive near-infrared camera. Results: Skin perfusion pressure increased in response to E-Stim therapy (P = .02), with maximum improvement observed at 60 min (11%; P = .007) compared with baseline; SPP reduced 10 min after therapy but remained higher than baseline (9%; P = .1). Magnitude of improvement at 60 min was negatively correlated with baseline SPP values (r = -0.45; P = .01), suggesting that those with lower perfusion could benefit more from E-Stim therapy. Similar trends were observed for SatO2, with statistically significant improvement for a subsample (n = 16) with moderate-to-severe peripheral artery disease. Conclusions: This study provides early results on the feasibility and effectiveness of E-Stim therapy to improve skin perfusion and SatO2. The magnitude of benefit is higher in those with poorer skin perfusion. Also, the effects of E-Stim could be washed out after stopping therapy, and regular daily application might be required for effective benefit in wound healing.

The impact of diabetic foot ulcers and unilateral offloading footwear on gait in people with diabetes.

BACKGROUND: Unilateral offloading footwear prescribed to patients with diabetic foot ulcers elevates one limb relative to the other, which may lead to limp and abnormal gait. This study investigated whether the unilateral foot ulcer and offloading combination negatively impacts gait function beyond diabetic peripheral neuropathy. METHODS: Eighty-six participants were recruited in 3 groups: 12 with diabetic peripheral neuropathy and unilateral foot ulcers wearing offloading footwear (offloading group, age = 55.6 ± 9.5 years, BMI = 30.9 ± 4.5 kg/m2), 27 with diabetic peripheral neuropathy (neuropathy group, age = 64.3 ± 7.7 years, BMI = 30.9 ± 5.4 kg/m2), and 47 non-diabetic controls (non-diabetic group, age = 62.9 ± 16.1 years, BMI = 29.0 ± 6.0 kg/m2). Gait function was quantified during a habitual speed walking test using a validated wearable platform. FINDINGS: The offloading group exhibited deteriorated gait function compared to the non-diabetic group (p < 0.005, Cohen's effect size d = 0.90-2.61). They also had decreased gait speed (p < 0.001, d = 1.79) and stride length (p < 0.001, d = 1.76), as well as increased gait cycle time (p < 0.001, d = 1.67) and limp (p < 0.050, d = 0.72-1.49) compared to the neuropathy group. The offloading group showed increased gait unsteadiness compared to the neuropathy group, but the difference did not reach statistical significance in our samples. INTERPRETATION: This study demonstrated that while diabetic peripheral neuropathy deteriorates gait function, including increasing gait unsteadiness and limp, the diabetic foot ulcer and offloading combination magnifies the deterioration beyond diabetic peripheral neuropathy. These findings promote caution of the current standards of care for treating diabetic foot ulcers with offloading footwear. However, it is possible that a contralateral shoe lift may remedy deteriorated gait function and improve quality of life for unilateral offloading users.

Accuracy of a foot temperature monitoring mat for predicting diabetic foot ulcers in patients with recent wounds or partial foot amputation.

AIMS: To assess the accuracy of once-daily foot temperature monitoring for predicting foot ulceration in diabetic patients with recent wounds and partial foot amputation, complications previously perceived as challenging. METHODS: We completed a planned analysis of existing data from a recent study in 129 participants with a previously-healed diabetic foot ulcer. We considered four cohorts: all participants, participants with partial foot amputation, participants with a recent wound, and participants without partial foot amputation and without a recent wound. We reported the prediction specificity, lead time, and annualized alert frequency in each cohort at maximum sensitivity. We assessed the two potentially challenging cohorts for non-inferior accuracy relative to the control cohort using Delong's method. RESULTS: We report non-inferior predictive accuracy in each of the two potentially-challenging cohorts relative to the control cohort (⍺ < 0.05). The alert lead time was similar across these cohorts, ranging from 33 to 42 days. CONCLUSIONS: Once-daily foot temperature monitoring is no less accurate for predicting foot ulceration in those with recent wounds and partial foot amputations than in those without these complications. These results support expanded practice of once-daily foot temperature monitoring, which may result in improved patient outcomes and reduced healthcare resource utilization.

Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses for Fall Prevention in Older Adults: A Randomized Controlled Trial.

OBJECTIVE: To examine the effects of bilateral custom-made ankle-foot orthoses (AFOs) to prevent falls for older adults with concern about or at risk for falling over 12-month daily use. DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Community-dwelling older adults. INTERVENTION: Half of the participants were randomly allocated to an intervention group (IG) that received fitted walking shoes and bilateral custom-made AFOs, and the other half were randomly allocated to a control group (CG) that only received fitted walking shoes. MEASUREMENTS: Self-reported fall history of 12-month duration was investigated at baseline and 12-month follow-up for both groups. Fall incidence rate and proportion of fallers were used as outcome measures to determine effects of 12-month footwear intervention in either group. PARTICIPANTS: Adults aged 65 years and older with concern about or at risk for falling (n = 44). RESULTS: No significant between-group differences in participant characteristics were observed at the baseline (P = .144-.882). Within the IG, significant reductions were found in the fall incidence rate (P = .039) and the proportion of fallers (P = .036) at the 12-month follow-up compared to the baseline. Within the CG, no significant change was found at the 12-month follow-up compared to the baseline for the fall incidence rate (P = .217) or the proportion of fallers (P = .757). When comparing the IG with the CG, there was no significant difference in the change from the baseline to the 12-month follow-up for the fall incidence rate (P = .572) or the proportion of fallers (P = .080). CONCLUSION: This study failed to demonstrate a significant benefit of bilateral custom-made AFOs to reduce falls compared to fitted walking shoes. However, the AFO users had significant reductions in falls compared to the preceding year. A future study with a larger sample size is recommended to confirm these observations. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02819011. J Am Geriatr Soc 67:1656-1661, 2019.

The Effect of Daily Use of Plantar Mechanical Stimulation Through Micro-Mobile Foot Compression Device Installed in Shoe Insoles on Vibration Perception, Gait, and Balance in People With Diabetic Peripheral Neuropathy.

OBJECTIVE: People with diabetic peripheral neuropathy (DPN) have impaired gait and balance performance. The aim of this study is to investigate therapeutic effectiveness of mechanical stimulation through a wearable foot compression device equipped in a shoe insole on vibration perception, balance control and gait performance in people with DPN. METHODS: Using a single-arm 4-week intervention study design, we examined effectiveness of daily use of shoes equipped with the foot compression device (Footbeat™, AVEX, Grand Junction, CO, USA) on improving vibration perception threshold (VPTmax), skin perfusion pressure (SPP), ankle brachial index (ABI), lower extremities edema (circumferences in the calf and ankle), and motor performance (postural sway with eyes open and closed conditions, and gait performance during normal, dual-task and fast walking). Thirty people with type 2 diabetes and symptoms of PN completed the experimental protocol. RESULTS: Improvements in VPTmax (before = 27.4 V, after = 23.3 V, P = .007, d = 0.33, where d denotes effect size), center-of-mass sway in the mediolateral direction with both eyes open and closed conditions (before = 0.94 cm, after = 0.76 cm, P = .020, d = 0.47; before = 1.10 cm, after = 0.83 cm, P = .033, d = 0.66, respectively), and stride velocity for normal walking, dual-task walking and fast walking tasks (before = 0.87 m/s, after = 0.96 m/s, P = .017, d = 0.41; before = 0.75 m/s, after = 0.91 m/s, P = .001, d = 0.77; before = 1.10 m/s, after = 1.20 m/s, P = .043, d = 0.33, respectively) were found post treatment. There was no significant improvement in SPP, ABI, and circumferences in the calf and ankle. CONCLUSIONS: Our findings suggest the wearable foot compression device may be effective for reducing neuropathic symptoms and enhancing motor performances in people with DPN.