Ulcer Recurrence Rate Research Articles

Medium-term outcomes of multi-disciplinary surgical management of non-ischemic diabetic heel ulcers

BackgroundHeel ulcers in patients with peripheral neuropathy and diabetes pose a significant challenge to treating physicians. Infection spreading to the os calcis is associated with a poor prognosis. There is no consensus on which method of surgical treatments results in better outcomes. The aim of this study was to assess patients’ survival, rate of ulcer healing following surgical treatment, along with limb salvage rate, time taken for healing, ulcer recurrence and patients’ functional outcome after healing. MethodsWe studied 29 patients (20 men, 9 women) presenting with diabetic neuropathic heel ulcers (30 feet) and no critical limb ischemia, were managed surgically in our unit and followed-up for a minimum of 12 months. We assessed their clinical and functional outcomes within a mean follow-up period of 28 months (12–83). Results11 out of 29 patients died (38%) with mean duration of post op survival being 31months (range 4–70). 14 ulcers (50%) healed fully within a mean of 360 days (131–1676). Limb salvage was achieved in 29 feet (97%). Only 5 out of 17 patients with diabetic nephropathy (p value 0.016) and 9 out of 24 ulcers with calcaneal osteomyelitis (p value 0.044) achieved full ulcer healing. Ulcer recurrence rate was 36% (5/14) within 12 months of achieving ulcer healing. Six patients were able to return to independent walking in surgical shoes while 11 patients were mobilising using either a crutch or frame. ConclusionWhile excellent limb salvage can be anticipated from the outcome of surgically managed infected heel ulcers in patients with diabetes, complete healing can still be slow and unpredictable. Significant medical co-morbidities in these patients make them vulnerable to medium-term post-operative complication and survival.

A comparison of cyanoacrylate glue and radiofrequency ablation techniques in the treatment of superficial venous reflux in CEAP 6 patients

ObjectiveVenous leg ulcers (CEAP [clinical, etiologic, anatomic, pathophysiologic] class 6) represent the most severe form of chronic venous insufficiency. As closure techniques for superficial venous reflux evolve, direct outcome comparisons of treatments are integral, because many studies have already demonstrated that early endovenous intervention improves wound healing. The present study compared the rates of venous wound healing between two techniques of superficial vein closure: ClosureFast radiofrequency ablation (RFA) and adhesive closure (VenaSeal; both Medtronic, Inc, Minneapolis, Minn). MethodsWe performed a multi-institutional retrospective review of all patients with CEAP class 6 who had undergone closure of their truncal veins from 2015 to 2020. Patients undergoing ClosureFast RFA were compared with those undergoing VenaSeal adhesive closure. The primary endpoint was the interval to wound healing from initial vein closure. The secondary endpoints included ulcer recurrence and infection rates. Bivariate analysis involved the χ2, Fisher exact, t, and Wilcoxon rank sum tests. Multivariate linear regression analysis was used to examine the factors affecting the time to wound healing in the most predictive model. Statistical significance was defined as P < .05. ResultsA total of 119 patients with CEAP 6 were included, with a median follow-up of 105 days (interquartile range, 44-208 days). Of the 119 limbs, 68 were treated with RFA and 51 with VenaSeal. Significantly more patients undergoing RFA had had a history of deep vein thrombosis (29% vs 10%; P = .01) and deep venous reflux (82% vs 51%; P = .003). The VenaSeal patients were older (72 years vs 65 years; P = .02) with a greater rate of coronary artery disease (16% vs 37%; P = .01). The median time to wound healing after the procedure was significantly shorter for VenaSeal than for RFA (43 vs 104 days; P = .001). Two RFA patients developed a postprocedure infection. The ulcer recurrence rate was 19.3% (22.1% for RFA vs 13.7% for VenaSeal; P = .25). On multivariate analysis, the treatment modality was the only significant predictor of the time to wound healing. When stratified by ulcer size as small (<3 cm2) vs large (>3 cm2), VenaSeal closure healed the wounds significantly faster for all ulcers. ConclusionsClosureFast and VenaSeal are both safe and effective treatments to eliminate truncal venous insufficiency. VenaSeal showed a superior time to wound healing compared with ClosureFast in both large and small ulcers.

Clopidogrel-Induced Gastric Injury in Rats is Attenuated by Stable Gastric Pentadecapeptide BPC 157.

AimAlthough Clopidogrel is safe in healthy volunteers, it can induce recurrence of gastric ulcers in high-risk patients. Here, we investigated the protective effect of the natural product, stable gastric pentadecapeptide 157 (BPC 157) on Clopidogrel-induced gastric injury.MethodsWe used acetic acid to induce gastric ulcer in Sprague Dawley rats. Clopidogrel alone or in combination with BPC 157 or L-NAME (nitric oxide system blockade) were administered after healing of acetic acid-induced ulcer. One percent methylcellulose solution was used as control. Ulcer recurrence rate and the ulcer index were compared between these groups. Gastric mucosal apoptosis rate, microscopic inflammation activity and angiogenesis markers vascular endothelial growth factor A (VEGF-A) and CD34 were examined by TUNEL, histological evaluations (HE) and immunohistochemistry (IHC). Pathways involved, expressions of endoplasmic reticulum (ER) stress apoptosis marker CHOP, angiogenic markers VEGF-A and its receptor VEGFR1, and endothelial NO synthase (eNOS) were all analyzed by Western blot.ResultsThis study indicated that Clopidogrel significantly induced the gastric ulcers recurrence, severe inflammation and ER stress related apoptosis of the gastric mucosa, suppressed the synthesis of angiogenic markers and eNOS. Furthermore, Clopidrogel intervention resulted in the activation of protein kinase B (AKT) and p38 mitogen-activated protein kinase (p38/MAPK). BPC 157 attenuated the gastric mucosal damage caused by Clopidogrel and reversed these molecular effects. However, NO blockade L-NAME weakened the protective effect and thus the molecular effects of BPC 157 on gastric mucosa.ConclusionIn conclusion, these results suggest that BPC 157 inhibited Clopidogrel-induced gastric mucosa injury partially by inhibition of gastric mucosa cell ER stress-mediated apoptosis and inflammation, and promoting gastric mucosa angiogenesis via VEGF-A/VEGFR1 mediated-AKT/p38/MAPK signaling pathways.

Diabetic foot syndrome-Part 1 : Definition, pathophysiology, diagnostics and classification

In Deutschland leben ca. 8 Mio. Menschen mit Diabetes mellitus. Eine Spätfolge dieser Erkrankung ist das diabetische Fußsyndrom (DFS), dessen Prävalenz stark ansteigt. Es umfasst alle Veränderungen am Fuß als Folge der diabetischen Polyneuropathie sowie mikro- und makroangiopathischer (periphere arterielle Verschlusskrankheit, PAVK) Veränderungen. Jährlich entstehen ca. 250.000 neue diabetische Fußulzera. Diese werden oft zu chronischen Wunden. Trotz intensiver Bemühungen um Prävention, frühzeitige Diagnostik und stadiengerechte Wundbehandlung werden in Deutschland jährlich ca. 13.000 Majoramputationen bei Diabetikern durchgeführt. Bei konsequenter Therapie des DFS in interdisziplinären Zentren mit Ausschöpfung aller Möglichkeiten der Wundbehandlung, der Druckentlastung sowie einer arteriellen Revaskularisation kann die Majoramputationsrate um bis zu 80 % gesenkt werden. Durch eine geeignete Präventionsstrategie wäre die große Gefahr der Rezidivulzera geringer.

Recurrence and influencing factors of diabetic foot ulcer in patients with type 2 diabetes mellitus

Objective: To investigate the recurrence and influencing factors of diabetic foot ulcer in patients with type 2 diabetes mellitus. Methods: Totally 185 type 2 diabetes patients with new-onset of diabetic foot ulcers admitted to Fuyang People's Hospital of Anhui Province from January 2011 to December 2015 were enrolled in this study, including 120 males and 65 females, aged 40-79 years. All the patients were followed up for 3 years, and their clinical data were retrospectively analyzed by the case-control study. The Kaplan-Meier cumulative recurrence curve was drawn according to the 3-year cumulative recurrence rate of diabetic foot ulcers. The time to visit, toe involvement, and amputation of involved toes in patients with recurrent diabetic foot ulcer were counted at the initial onset and the recurrence of the ulcers, respectively, and the data were statistically analyzed with t test and chi-square test. According to the recurrence of diabetic foot ulcers, the patients were divided into foot ulcer recurrence group and foot ulcer non-recurrence group. The gender, age, course of diabetes mellitus, length of hospital stay, visit time, body mass index, glycosylated hemoglobin HbA1c, total bilirubin, albumin, creatinine, cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL), triglycerides, hemoglobin, white blood cell count, toe involvement, toe amputation, ankle-brachial index, diabetic retinopathy (DR), diabetic peripheral neuropathy (DPN), diabetic nephropathy (DN), history of hypertension, cardio-cerebrovascular disease, smoking, residence, solitary life, and walking disorder of patients between the two groups were compared, and the data were statistically analyzed with t test and chi-square test. Log-rank test was performed on the indexes with P<0.1 in comparison between two groups, and the indexes with statistically significant differences in Log-rank test were analyzed by multivariate Cox regression analysis to screen the influencing factors of recurrence of diabetic foot ulcer. Results: (1) The 3-year cumulative recurrence rate of diabetic foot ulcers in 185 patients with type 2 diabetes mellitus was 47.0% (87/185). (2) For 87 patients with diabetic foot ulcer recurrence, compared with that at the initial onset of the ulcers, the visit time was significantly shorter (t=10.593, P<0.01), the toe amputation rate was significantly increased (χ(2)=5.118, P<0.05), but there was no obvious change in toe involvement at the recurrence of the ulcers. (3) There were statistically significant differences in age, course of diabetes mellitus, length of hospital stay, body mass index, glycosylated hemoglobin HbA1c, total bilirubin, albumin, creatinine, cholesterol, LDL, HDL, hemoglobin, white blood cell count, gender, toe amputation, ankle-brachial index, DR, history of cardio-cerebrovascular disease, solitary life, and walking disorder of patients between foot ulcer recurrence group (87 patients) and foot ulcer non-recurrence group (98 patients) (t=5.123, 4.242, 5.324, -24.572, 6.102, -1.984, -9.747, 3.226, 3.076, 3.646, -4.683, -7.502, 8.095, χ(2)=5.621, 18.433, 4.546, 5.785, 9.655, 7.625, 7.886, P<0.05 or P<0.01), while the rest of the indexes of patients between the two groups were similar. Log-rank test showed that the two groups had statistically significant differences in age, course of diabetes mellitus, length of hospital stay, glycosylated hemoglobin HbA1c, total bilirubin, albumin, creatinine, ankle-brachial index, DPN, and walking disorder (χ(2)=210.046, 44.837, 34.107, 98.685, 66.532, 294.451, 260.554, 5.012, 6.818, 11.160, P<0.05 or P<0.01). Age, total bilirubin, albumin, DPN, and walking disorder were the influencing factors for the recurrence of diabetic foot ulcers in patients with type 2 diabetes mellitus (hazard ratio=1.024, 0.678, 0.849, 2.335, 4.099, 95% confidence interval=1.001-1.047, 0.558-0.823, 0.797-0.904, 1.280-4.258, 2.044-8.223, P<0.05 or P<0.01). Conclusions: The 3-year cumulative recurrence rate of diabetic foot ulcers in patients with type 2 diabetes mellitus is relatively high, with the influencing factors being age, total bilirubin, albumin, DPN, and walking disorder.

Lower resource utilization for patients with healed diabetic foot ulcers during participation in a prevention program with foot temperature monitoring

IntroductionWe assessed the impact of a diabetic foot ulcer prevention program incorporating once-daily foot temperature monitoring on hospitalizations, emergency department and outpatient visits, and rates of diabetic foot ulcer recurrence...

A Meta-Analysis of the Outcomes of Metatarsal Head Resection for the Treatment of Neuropathic Diabetic Foot Ulcers.

Significance: Diabetic foot ulcers (DFUs) are associated with high morbidity, mortality, and health costs. Standard care (SC) associated with nonsurgical offloading is the mainstay treatment for DFUs, but it has high recurrence and infection rates. Metatarsal head resection (MHR) has been proposed as an effective surgical offloading technique for the treatment of plantar neuropathic DFUs, but with no evidence synthesis yet. Recent Advances: Based on PRISMA guidelines, a meta-analysis was conducted to assess the efficacy of MHR. Four electronic databases were searched for. Eleven studies met the inclusion criteria with a total of 477 patients (494 feet and 593 neuropathic forefoot ulcers). The studies included three retrospective comparative studies and eight case series. Critical Issues: Meta-analytical results of comparative studies on recent noninfected DFUs showed MHR having significantly better rates of healing, time to healing, ulcer recurrence, and infection than SC. Failure to heal, recurrence, and infection rates were 4 times higher in the SC group than in the MHR group, and the amputation rate was two times higher in the SC group than in the MHR group. The outcomes of the meta-analysis of case series on chronic and recalcitrant ulcers treated with MHR were similar. Future Directions: Considering the natural history of DFUs treated conservatively and the satisfactory outcomes with a significantly low complication rate of MHR, physicians should consider the use of MHR more often and include this technique in the early management of DFUs. Scope and Significance: DFU impose great public health burden around the globe. Standard of care using in-office debridement and topical agents is the usual mainstay of treatment. However, such conservative care is known to result in high rates of ulcer recurrence and complications. In this systematic review, we quantitatively investigate the outcomes of a surgical off-loading technique, the MHR in the treatment of chronic plantar neuropathic wounds. Translational Relevance: Many biochemical factors are implicated in the complex process of wound healing. In the case of diabetic neuropathic ulcers of the forefoot, additional mechanical factors induced by the presence of diabetic neuropathy lead to high pressure loads of the metatarsal heads on the plantar skin. With time, such chronic loads could favor ulcer formation. Removal of the causal mechanical factor could alleviate the pressure and allow wound healing. Clinical Relevance: Neuropathic plantar ulcers are difficult-to-heal wounds and chronicity is associated to frequent hospitalizations, higher rates of amputation, and mortality. Early removal of the indirect causal agent, the resection of the metatarsal head, after failure of a well-conducted conservative standard of care could be a needed solution for wound healing and consequently a potential for reducing complications and costs.

Long-term Clinical and Cost-effectiveness of Early Endovenous Ablation in Venous Ulceration

One-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux. To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration. Between October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months' duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019. Patients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team. The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness. The early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57-1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480-0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year. Early endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence. ClinicalTrials.gov identifier: ISRCTN02335796.

A randomized clinical trial of the effects of saphenous and perforating veins radiofrequency ablation on venous ulcer healing (VUERT trial).

To investigate whether radiofrequency endovenous ablation (RFA) of saphenous and perforating veins increases venous leg ulcer (VLU) healing rates and prevents ulcer recurrence. This prospective, open-label, randomized, controlled, single-center trial recruited 56 patients with VLU divided into: compression alone (CR, N = 29) and RFA plus compression (RF, N = 27). Primary endpoints were ulcer recurrence rate at 12 months; and ulcer healing rates at 6, 12, and 24 weeks. Secondary endpoints were ulcer healing velocity; and Venous Clinical Severity Score (VCSS). Recurrence was lower in the RF group (p < .001), as well as mean VCSS after treatment (p = .001). There were no significant between-group differences in healing rates. Healing velocity was faster in the RF group (p = 0.049). In the RF group, 2 participants had type 1 endovenous heat-induced thrombosis (EHIT). RFA plus compression is an excellent treatment for VLU because of its safety, effectiveness, and impact on ulcer recurrence reduction and clinical outcome.Registration: Clinicaltrials.gov, NCT03293836, clinicaltrials.gov.

Treatment of Superficial Venous Reflux in CEAP 6 Patients: A Comparison of Cyanoacrylate Glue and Radiofrequency Ablation Techniques

Abstract Objective Venous leg ulcers (CEAP [clinical, etiologic, anatomic, pathophysiologic] class 6) represent the most severe form of chronic venous insufficiency. As closure techniques for superficial venous reflux evolve, direct outcome comparisons of treatments are integral, because many studies have already demonstrated that early endovenous intervention improves wound healing. The present study compared the rates of venous wound healing between two techniques of superficial vein closure: ClosureFast radiofrequency ablation (RFA) and adhesive closure (VenaSeal; both Medtronic, Inc, Minneapolis, Minn). Methods We performed a multi-institutional retrospective review of all patients with CEAP class 6 who had undergone closure of their truncal veins from 2015 to 2020. Patients undergoing ClosureFast RFA were compared with those undergoing VenaSeal adhesive closure. The primary endpoint was the interval to wound healing from initial vein closure. The secondary endpoints included ulcer recurrence and infection rates. Bivariate analysis involved the χ2, Fisher exact, t, and Wilcoxon rank sum tests. Multivariate linear regression analysis was used to examine the factors affecting the time to wound healing in the most predictive model. Statistical significance was defined as P Results A total of 119 patients with CEAP 6 were included, with a median follow-up of 105 days (interquartile range, 44-208 days). Of the 119 limbs, 68 were treated with RFA and 51 with VenaSeal. Significantly more patients undergoing RFA had had a history of deep vein thrombosis (29% vs 10%; P = .01) and deep venous reflux (82% vs 51%; P = .003). The VenaSeal patients were older (72 years vs 65 years; P = .02) with a greater rate of coronary artery disease (16% vs 37%; P = .01). The median time to wound healing after the procedure was significantly shorter for VenaSeal than for RFA (43 vs 104 days; P = .001). Two RFA patients developed a postprocedure infection. The ulcer recurrence rate was 19.3% (22.1% for RFA vs 13.7% for VenaSeal; P = .25). On multivariate analysis, the treatment modality was the only significant predictor of the time to wound healing. When stratified by ulcer size as small ( 3 cm2), VenaSeal closure healed the wounds significantly faster for all ulcers. Conclusion ClosureFast and VenaSeal are both safe and effective treatments to eliminate truncal venous insufficiency. VenaSeal showed a superior time to wound healing compared with ClosureFast in both large and small ulcers.

Eosinophilic gastroenteritis as a cause of non-Helicobacter pylori, non-gastrotoxic drug ulcers in children

BackgroundWhile Helicobacter pylori (H. pylori) ulcers has declined recently, H. pylori-negative and/or gastrotoxic drug-negative peptic ulcers (HNGN-PU) has increased. This study aimed to analyze the etiology of peptic ulcers in children and the differences in clinical, laboratory, endoscopic, and histopathologic findings of peptic ulcers according to etiology, including eosinophilic gastroenteritis (EoGE).MethodsIn total, 255 children (157 boys and 98 girls) with peptic ulcers were recruited. The subjects were categorized into 5 groups according to the etiology of the ulcer: 1) H. pylori infection (n = 51); 2) gastrotoxic drugs (n = 18); 3) idiopathic (n = 144); 4) systemic disease (n = 23); 5) EoGE (n = 19). Clinical data were reviewed and analyzed retrospectively.ResultsAge at diagnosis, ulcer recurrence, atopic dermatitis history, white blood cell count, blood eosinophil count, platelet count, serum albumin level, iron level, erythrocyte sedimentation rate, and C-reactive protein level differed significantly among the 5 groups (all p < 0.05). Regarding endoscopic findings, multiple ulcers and gastric mucosal nodularity differed among the 5 groups (all p < 0.05). When comparing the EoGE ulcer group with the others, EoGE group revealed older ages (p = 0.022), higher rates of ulcer recurrence (p = 0.018), atopic dermatitis history (p = 0.001), and both blood and tissue eosinophilia (both p = 0.001).ConclusionsEoGE ulcers constituted 10.2% of HNGN-PU in pediatric patients. In children with HNGN-PU, peripheral eosinophilia, ulcer recurrence, and atopic dermatitis history might imply EoGE, necessitating thorough investigation of tissue eosinophils during endoscopic biopsy.Trial registrationA total of 255 children was retrospectively registered between between July 2003 and April 2017.

The safety and efficacy of Sclerosing foam on treating venous leg ulcers: Protocol for systematic review and meta-analysis.

Background:Venous leg ulcers (VLUs) are common throughout the world, which seriously affects the patient's work and life. Relevant researches suggested that sclerosing foam (SF) has potential benefits for VLUs. However, there is no consistent conclusion. The purpose of our study is to assess whether SF is effective and safe for VLUs.Methods:Relevant clinical randomized controlled trials will be obtained from a search of 8 databases (with no language restrictions) from their inception to May 2020: PubMed, the Cochrane Library, EMBASE, Web of Science, China National Knowledge Infrastructure Database, Wanfang Database, China Science and Technology Journal Database, and Chinese Biological Medicine. Data will be analyzed using RevMan 5.3 after literature screening and data extraction according to predefined inclusion and exclusion criteria. Cochrane Collaboration Risk of bias Tool will be applied in evaluating the quality of enrolled articles. The primary outcome is Closure of venous leg ulcers, ulcer healing rate, adverse events related to SF. The secondary outcomes include ulcer healing time, ulcer recurrence rate, pain. Risk ratio will be used for categorical data; mean differences will be used for measurement data. Where possible and appropriate, meta-analysis will be performed for each outcome.Results:To clarify whether Sclerosing foam can be safe and efficient on treating venous leg ulcers.Conclusion:Our review will provide useful information to judge whether Sclerosing Foam is an effective and safe intervention for patients with venous leg ulcers.

Temperature- and Pressure-Regulating Insoles for Prevention of Diabetic Foot Ulcers

Diabetic foot ulcers (DFUs) pose a major threat to the United States healthcare system as well as patients and their families. High ulcer recurrence rates indicate that existing preventive measures are not effective. A new generation of multimodal preventive devices may reduce ulceration and amputation rates. Because previous research has revealed that tissue maintained at cooler temperatures is more resistant to breaking down, the evaluated technology may prevent foot ulceration. The purpose of this study was to test previously designed Temperature and Pressure Monitoring and Regulating Insoles (TAPMARI) in diabetic neuropathic and healthy subjects. A cooling unit, a mini-water pump, a battery pack, and a microcontroller (or simply thermostat) were placed inside a box attached to the subjects’ calf, which provided cooling inside the shoe. The microcontroller was set at 28°C. Eight subjects provided informed consent, 3 of whom had diabetic neuropathy. Subjects used the instrumented shoe on the right foot and the matching control shoe on the left and walked on a treadmill for 5 minutes at self-selected speeds. Baseline and postwalking thermographs were obtained with a thermal camera. At the 2-hour midpoint, subjects again walked on the treadmill for 5 minutes at self-selected speeds. Second baseline and postwalking thermographs were captured. Plantar pressure distributions were also quantified. The TAPMARI successfully regulated foot temperatures at or below the target temperature. The mean baseline temperature of the right (regulated) and left (control) feet were 28.1 ± 1.9°C (mean ± standard deviation) for all subjects. The mean temperatures at the end of the study were 25.9 ± 2.5°C (right) and 31.7 ± 1.6°C (left) in all subjects. In the diabetic neuropathy group, the final mean temperatures were 27.5 ± 2.4°C (right) and 31.6 ± 0.8°C (left), which indicated that the temperature goal was met inside the instrumented shoe. By regulating temperatures, TAPMARI may reduce the metabolic demands in the foot and prevent cell autolysis by eliminating the imbalance between oxygen demand and supply. This study warrants further development and testing of TAPMARI as well as investigating the clinical effectiveness in preventing DFUs.

Treatment of superficial and perforator reflux and deep venous stenosis improves healing of chronic venous leg ulcers

ObjectiveTo evaluate the impact of three treatment modalities, superficial truncal vein ablation, perforator vein ablation, and deep venous stenting on venous leg ulcer (VLU) healing, as well as their cumulative effect on ulcer healing, in an attempt to establish the best algorithm for the treatment of chronic and recalcitrant VLUs. MethodsMulticenter retrospective cohort study using a standardized database to evaluate patients with chronic venous ulcers treated between January 2013 and December 2017. ResultsEight-hundred thirty-two consecutive patients with VLU were identified at 11 centers in the United States. All patients were initially managed with wound care and compression for at least 2 months. Compression and wound care management alone, used in 187 patients, led to ulcer healing in 75% of patients by 36 months. Ulcer recurrence in patients managed without surgery at 6, 12, and 24 months was 3%, 5% and 15%, respectively. Five hundred twenty-eight patients underwent ablation of incompetent superficial veins, and 344 of those also underwent incompetent perforator ablation. Patients who underwent truncal vein ablation alone had an ulcer healing rate of 51% at 36 months. Patients who received both superficial and perforator ablation were significantly younger, and had a 17% improvement in healing at 36 months (68% vs 51%, respectively), but there was no impact of combined superficial and perforator ablations on ulcer recurrence rates. One hundred thirty-four patients had stenosis of one of more lower extremity deep veins and 95 (71%) underwent endovenous stenting. Ulcer healing and recurrence rates for those who underwent stent placement alone was 77% and 27%, respectively, at 36 months. Patients who underwent deep venous stenting and ablation of both incompetent truncal and perforator veins had an ulcer healing rate of 87% at 36 months and ulcer recurrence of 26% at 24 months. ConclusionsThis study demonstrates that correction of superficial truncal vein reflux, as well as deep vein stenosis, both contribute to healing of VLU. Patients who fail to heal their VLU after superficial and perforator ablation should have the iliocaval system imaged to identify hemodynamically significant stenoses or occlusions amenable to stenting, which facilitates venous ulcer healing even in patients with large ulcers.

Topical Curcumin and Triamcinolone Acetonide in Recurrent Minor Aphthous Ulcers: A Pilot Trial

To evaluate the efficacy of topical curcumin and topical triamcinolone acetonide in a professional population with minor aphthous ulcers by assessing six clinical variables: site, size, pain, healing period, frequency of recurrence and number of ulcers. This randomized, parallel designed pilot trial was performed on 60 symptomatic individuals with minor aphthous ulcer. Willing participants were allocated randomly into group I and group II. Participants in group I were treated with topical curcumin and group II were treated with topical triamcinolone acetonide for a period of 6 months. All participants were blinded to the drug they received. Participants were assessed on day 1, day 3, day 5, day 7, and after healing for symptomatic reduction in pain, size, healing period, frequency of recurrence, and in the number of ulcers. Statistically, independent sample t test, Chi-square test, and Log rank Kaplan-Meier survival analysis were performed. Lower labial mucosa was found to be the predominant site of minor aphthous ulcer in both the groups. A gradual reduction in pain and size was noted in both the groups with statistical significance of p value <0.001. All the ulcers in both the groups healed completely without scarring within 2 weeks with statistical significance. In both the treatment groups, new ulcers occurred throughout the follow-up period of 6 months. The mean number of the ulcers are statistically not significant with p value >0.05. Our study showed clinically beneficial effects with topical curcumin with regard to ulcer size, pain, healing, and recurrence rate. Also topical curcumin gel was well tolerated and performed ot par with topical triamcinolone acetonide oral paste with a borderline favorable result with triamcinolone. Curcumin can be safely recommended on a long-term basis as a more appealing therapeutic agent and is a better alternative choice for aphthous ulcers in children, pregnant woman, lactating mother, and in immunocompromised individuals.

Mobility advice to help prevent re-ulceration in diabetes.

Clinicians and patients face a dilemma in understanding how best to resume walking after a healed diabetic neuropathic ulcer. The objectives of this brief review are to: provide context for the patient's health and mobility status; propose 5 suggestions to safely and effectively progress mobility following a healed foot ulcer; and to consider topics for future research to improve care in this area. Rates of ulcer recurrence and mortality are high, and activity is low following a diabetic foot wound. Medical and rehabilitation approaches have emphasized protection of the insensitive, fragile foot with the hope to prevent subsequent harm to the foot and person. In particular, the 1-2 months following wound unloading and "healing" have the greatest risk for ulcer recurrence. While early protection should be emphasized, a growing body of evidence suggests that over-protection of the foot and limited walking can be harmful, presumably because of the negative effects of prolonged immobility and stress protection. Multiple recent studies report the ability of exercise and walking to have a positive effect on various diabetic foot outcomes without additional harm. Much less is known about how an ulcerated foot can resume walking after the wound is healed. This review integrates available guidelines, evidence, and precautions to suggest advice on how best to resume and progress walking in this population at high risk for ulcer recurrence.

Factors that influence venous leg ulcer healing and recurrence rate after endovenous radiofrequency ablation of incompetent saphenous vein

ObjectiveEndovenous radiofrequency ablation (RFA) is one of the most popular techniques for correcting superficial vein reflux. However, the effectiveness of RFA of superficial vein reflux in patients with active or healed venous leg ulcer (VLU) is unknown. Accordingly, the objective of this study was to evaluate the healing rate, the recurrence rate, and the factors significantly associated with healing and recurrence in patients with active or healed VLU who had superficial venous reflux treated with RFA. MethodsWe retrospectively reviewed all healed VLU or active VLU patients treated with RFA at the Division of Vascular Surgery, Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, during January 2011 to December 2017 to evaluate the rate of VLU healing and recurrence. Time to healing and time to ulcer recurrence were determined by Kaplan-Meier survival analysis. Risk factors were assessed to determine their association with VLU healing and recurrence by Cox regression survival analysis. ResultsRFA of the great saphenous vein (n = 56), anterior accessory saphenous vein (n = 5), or both (n = 1) was performed on 62 limbs with active (n = 32) or healed (n = 30) VLUs. The mean age of patients was 65.4 ± 9.8 years, and 80% were female. Deep venous insufficiency was present in 10 limbs (16%). Pathologic perforating vein was found in 17 patients (27%). Concomitant ultrasound-guided foam sclerotherapy (UGFS) of the pathologic perforating vein was performed in 12 limbs (19%). Concomitant phlebectomy was performed in 19 limbs (31%). The median follow-up time was 753 days after RFA. VLU healed in 31% of patients at 3 months, in 56% at 6 months, and in 66% at 1 year after RFA. Concomitant UGFS of the pathologic perforating vein was the only factor significantly associated with VLU healing (hazard ratio, 2.84; 95% confidence interval, 1.07-7.55; P = .037). VLU recurrence was found in 8% of patients at 1 year, in 14% at 2 years, and in 23% at 3 years after RFA. Deep vein reflux was the only identified risk factor for VLU recurrence (hazard ratio, 3.72; 95% confidence interval, 1.05-13.21; P = .042). ConclusionsUGFS of the pathologic perforating vein at the time of RFA of saphenous vein reflux improved VLU healing. VLU recurrence was more frequent in patients with concomitant deep vein reflux. The authors suggest performing UGFS of the pathologic perforating vein at the time of RFA to improve VLU healing and monitoring of patients with associated deep vein reflux for ulcer recurrence.

Five Year Ulcer Recurrence Following Foam Sclerotherapy

Introduction: Long term data from the ESCHAR study demonstrated that superficial venous surgery reduces the risk of ulcer recurrence to 12% at one year and 31% at four years. As ultrasound guided foam sclerotherapy (UGFS) is an attractive alternative to surgery, the aim of this study was to assess long-term ulcer recurrence and recanalisation rates following UGFS. Methods: Open (CEAP 6) or recently healed (CEAP 5) chronic venous leg ulcers were treated with UGFS between July 2010 and August 2012. One, two, three, four and five-year ulcer recurrence rates were calculated using Kaplan-Meier survival analysis. Venous Duplex scans were performed at two weeks and annually for five years. Recanalisation was classified as ‘complete’ when the lumen was patent in a previously occluded vein and ‘segmental’ when there was a reduction in the length of occlusion. Results: A total of 100 limbs were treated in 92 patients; 86 were CEAP 5 and 14 were CEAP 6. At two weeks, complete or short segment occlusion was demonstrated in 99/100 legs. Complete follow-up was 93%, 88%, 82%, 74% and 68% at one, two, three years, four and five years respectively. Kaplan-Meier survival analysis showed ulcer recurrence rates at one, two, three, four and five years as 2.3%, 5.1%, 11.3%, 12.2% and 18.4% respectively. Up to five years: 40% of legs remained occluded; 20% demonstrated complete recanalisation with reflux and 40% demonstrated segmental recanalisation with reflux. Ulcer recurrence was demonstrated in 21% and 14% of legs demonstrating complete recanalisation and segmental recanalisation respectively at five years, with 16% in legs remaining occluded (p=n.s, Chi-Squared test). Conclusion: Long term ulcer recurrence rates were low in this study, and whilst recanalisation of the treated veins was common, it did not predict long term ulcer recurrence.

Study on the Effect of the Five-in-One Comprehensive Limb Salvage Technologies of Treating Severe Diabetic Foot.

Objective: To explore the clinical efficacy and advantages of five-in-one comprehensive limb salvage technologies for the treatment of severe diabetic foot ulcer (DFU). Approach: Clinical data for 120 patients with severe DFU treated between January 2012 and December 2017 were analyzed retrospectively. The control group (48 cases) was treated with traditional therapies, including controlling blood sugar, improving microcirculation, preserving nerve function, and dressing changes, whereas the experimental group (72 cases) was treated with traditional therapy combined with additional techniques, such as early and thorough debridement, negative pressure wound therapy, revascularization, and skin graft or flap. Ankle-brachial index (ABI), transcutaneous oxygen pressure (TcPO2), wound healing rate, healing time, ulcer recurrence rate, and amputation rate were recorded. Results: Compared with the control group, the experimental group significantly improved wound healing rate (93.1% vs. 72.9%; p < 0.01), decreased wound healing time (16.2 ± 5.4 days vs. 32.2 ± 7.8 days; p < 0.05), reduced major limb amputation rate (1.4% vs. 10.4%, p < 0.05), and ulcer recurrence rate (5.6% vs. 14.6%; p < 0.05). There were no significant differences in amputation rate between experimental and control group (29.2% vs. 33.3%, p = 0.628). After revascularization, the revascularization group showed significantly improved ABI (0.75 ± 0.21 vs. 0.35 ± 0.16, p < 0.05) and TcPO2 (36 ± 6 mmHg vs. 15 ± 4 mmHg, p < 0.05). Innovation: We propose a five-in-one comprehensive treatment method, which provides a multidisciplinary cooperative model for comprehensive medical and surgical treatments for DFU. Conclusion: The five-in-one comprehensive limb salvage treatment technologies played a vital role in enhancing the healing rate of severe DFU, shortening the healing time, and reducing the rate of recurrence and major amputation, thus improving the overall quality of life.

Incidence and Risk Factors Associated With Ulcer Recurrence Among Patients With Diabetic Foot Ulcers Treated in a Multidisciplinary Setting

BackgroundRecent studies demonstrate favorable diabetic foot ulcer (DFU) healing outcomes with the implementation of a multidisciplinary team. We aimed to describe the incidence of and risk factors associated with ulcer recurrence after initial complete healing among a cohort of patients with DFU treated in a multidisciplinary setting. MethodsAll patients presenting to our multidisciplinary diabetic limb preservation service from 6/2012-04/2018 were enrolled in a prospective database. The incidence of ulcer recurrence after complete wound healing was assessed per limb using the Kaplan-Meier method, and a stepwise multivariable Cox proportional hazards model was created to identify independent predictors of ulcer recurrence. ResultsA total of 244 patients with 304 affected limbs were included. Ulcer recurrence rates at one and 3 y after healing were 30.6 ± 3.0% and 64.4 ± 5.2%, respectively. Recurrent ulcers were smaller (4.4 ± 1.1 cm2versus 8.2 ± 1.2 cm2; P = 0.04) and had a lower Wound, Ischemia, and foot Infection stage (stage 4: 7.7% versus 22.4%; P < 0.001) than initial ulcers, and wound healing time was significantly reduced (95.0 ± 9.8 versus 131.8 ± 7.0 d; P = 0.004). Independent predictors of ulcer recurrence included abnormal proprioception (HR, 1.57 [95% CI 1.02-4.43]) and younger age (HR 1.02 per year [95% CI 1.01-1.04]). ConclusionsIn this prospective cohort of patients with DFU, time to diagnosis and healing was significantly lower for recurrent ulcers, and downstaging was common. These data suggest that engaging patients with DFU in a multidisciplinary care model with frequent follow-up and focused patient education may serve to decrease DFU morbidity.