Development of Cyclic Pressure Offloading Insole for Diabetic Foot Ulcer Prevention.

Introduction. The likelihood of developing a diabetic foot ulcer (DFU) during one's lifetime for individuals with diabetes mellitus is around 19% to 34%. Continuous and repetitive loading on soft tissues are the major causative factors for DFU. This paper introduces an air cell array insole designed for cyclically offloading pressure from plantar regions to reduce repetitive stress and loading on foot. Materials and Methods. The insole comprises an air cell array insole and a pneumatic control unit. The interface pressure was evaluated in static and dynamic conditions at 3 different air cell internal pressures (6.9, 10.3, and 13.8 kPa). Plantar interface pressure was measured using a commercial pressure system, and data were analyzed using paired t test. Average interface pressure and peak pressure (PP) were studied to evaluate the functionality and effectiveness of the insole. Results. The analysis of static pressure data revealed that cyclic offloading significantly (p < .05) reduced PP in 4 tested cells corresponding to big toe, metatarsal heads, and heel areas with the maximum mean difference of 12.9 kPa observed in big toe region. Similarly, dynamic pressure data analysis showed that cyclic offloading significantly (p < .05) reduced PP in these areas, with the highest mean PP reduction of 36.98 kPa in the big toe region. Discussion. Results show the insole's capability to reduce plantar pressure through cyclic offloading. Internal pressure of air cells significantly affects the overall pressure reduction and must be chosen based on the user's weight. Conclusion. Results confirm that the insole with offloading capabilities has the potential to reduce the risk of developing DFUs by alleviating the plantar stress during both static and dynamic conditions.

Amputation and infection are the greatest fears in patients with diabetes foot complications.

AIMS: To determine the degree patients with diabetic foot ulcers, Charcot neuroarthropathy and neuropathic fractures and dislocations fear complications (death, dialysis, heart attack, stroke, blindness, diabetic foot infection, minor and major lower extremity amputation [LEA]) that can occur and to assess if there is a difference between fears of patients with diabetic foot ulcers, Charcot neuroarthropathy and neuropathic fractures and dislocations and diabetic patients without these complications. METHODS: 478 patients completed an eight question Likert scale survey. The study group was defined as non-infected foot ulcers, neuropathic fractures and Charcot neuroarthropathy. RESULTS: Of the 478 patients, 121 (25.3 %) had diabetic foot ulcers, Charcot neuroarthropathy or neuropathic fractures and dislocations and 357 (74.7 %) did not. The study group had significantly higher odds of reporting extreme fear of foot infection (OR 2.8, 95 % CI 1.8-4.5), major LEA (OR 2.8, 95 % CI 1.8-4.4), minor LEA (OR 2.3, 95 % CI 1.5-3.5), blindness (OR 2.0, 95 % CI 1.3-3.2), dialysis (OR 2.0, 95 % CI 1.1-3.3), and death (OR 2.4, 95 % CI 1.4-4.2). In the study group highest rated fear measures were foot infection (3.71, SD 1.23), minor amputation (3.67, SD 1.45) and major amputation (3.63, SD 1.52). There were no significant differences in the mean fear of infection, minor amputation or major amputation. CONCLUSION: Patients with diabetic foot ulcers, Charcot neuroarthropathy or neuropathic fractures and dislocations reported higher fear ratings of diabetes-related complications compared to those without these complications.

Wound Biofilm: Current Perspectives and Strategies on Biofilm Disruption and Treatments

The presence of bio lm remains a challenging factor that contributes to the delayed healing of many chronic wounds. The major threat of chronic wound bio lms is their substantial protection from host immunities and extreme tolerance to antimicrobial agents. To help guide the development of wound treatment strategies, a panel of experts experienced in clinical and laboratory aspects of biofilm convened to discuss what is understood and not yet understood about biofilms and what is needed to better identify and treat chronic wounds in which biofilm is suspected. This article reviews evidence of the problem of biofilms in chronic wounds, summarizes literature-based and experience-based recommendations from the panel meeting, and identities future and emerging technologies needed to address the current gaps in knowledge. While currently there is insufficient evidence to provide an accurate comparison of the effectiveness of current therapies/products in reducing or removing biofilm, research has shown that in addition to debridement, appropriate topical antimicrobial application can suppress biofilm reformation. Because the majority of the resistance of bacteria in a biofilm population is expressed by its own secreted matrix of extracellular polymeric substance (EPS), panel members stressed the need for a paradigm shift toward biofilm treatment strategies that disrupt this shield. High-osmolarity surfactant solution technology is emerging as a potential multimodal treatment that has shown promise in EPS disruption and prevention of biofilm formation when used immediately post debridement. Panel members advocated incorporating an EPS-disrupting technology into an antibiofilm treatment approach for all chronic wounds. The activity of this panel is a step toward identifying technology and research needed to improve biofilm management of chronic wounds.

Improved Quality of Life After Transtibial Amputation in Patients With Diabetes-Related Foot Complications.

The purpose of this study was to evaluate health-related quality of life after major lower-extremity amputation in a cohort of patients with diabetes mellitus. We evaluated 81 patients with diabetes and transtibial amputation (TTA) who had a minimum of 1 year of follow-up. Of these 81 patients, 50.6% completed the Short Form Survey (SF-36) and the Foot and Ankle Ability Measure (FAAM) preoperatively and postoperatively. Outcome measures before and after TTA were compared using Welch's ANOVA for continuous variables and Fisher's exact test for categorical variables. There was significant improvement in all 8 subscales of the SF-36, physical component summary (PCS) score, mental component summary (MCS) score, and the FAAM. The median SF-36 PCS score improved from 26.2 to 36.6 preoperatively versus postoperatively ( P < .0005). The postoperative PCS score improved in 75.6% of patients and worsened in 24.4%. The median SF-36 MCS score improved from 43.7 to 56.1 preoperatively versus postoperatively ( P < .0005). Both the FAAM activities of daily living (ADL; P < .005) and FAAM sports scores ( P < .05) improved significantly. The postoperative FAAM general/ADL score improved in 75.6% of patients and worsened in 24.4%. Patients who were nonambulatory postoperatively had significantly lower SF-36 general health subscale scores and lower FAAM scores than patients who were ambulatory postoperatively. In select patients with nonfunctional lower extremities resulting from instability and/or chronic infection, TTA can result in significant improvement in quality of life and lower-extremity function. We acknowledge that 25% of patients had a reduction in self-reported quality of life; however, 75% of patients improved their quality of life.

End-Stage Renal Disease Negatively Affects Physical Quality of Life in Patients With Diabetic Foot Complications.

The aim of this study was to evaluate the impact of end-stage renal disease (ESRD) on health-related quality of life (QOL) in patients with diabetic foot disease. We compared a group of 30 diabetic patients with ESRD requiring dialysis to a group of 60 diabetic patients without ESRD. Both groups consisted of patients with active diabetic foot disease (ulcer, Charcot, infection) and were matched with regard to age and gender. Self-reported QOL was assessed using the Short Form-36 (SF-36) physical and mental component summary (PCS and MCS) scores and the region-specific Foot and Ankle Ability Measure (FAAM). Diabetic foot patients with ESRD requiring dialysis were found to have significantly higher creatinine levels, lower hemoglobin levels, lower albumin levels, higher rates of peripheral arterial disease, and lower rates of Charcot neuroarthropathy than patients without ESRD. The median PCS was significantly lower in the ESRD group; however, no significant difference was found when comparing the median MCS and FAAM. Patients who ultimately died had a tendency to report lower PCS scores at baseline compared with those patients who did not die ( P = .07). Patients who ultimately required major amputation also reported lower PCS scores at baseline. ESRD negatively affects physical QOL to a greater degree than mental QOL in patients with diabetic foot disease. The SF-36 may not be sensitive enough to capture impaired mental QOL because both groups had relatively high MCS scores. Low physical QOL may be associated with mortality and the eventual need for major amputation.

Comparison of Transtibial Amputations in Diabetic Patients With and Without End-Stage Renal Disease.

BACKGROUND: The primary purpose of this retrospective study was to report on a consecutive series of 102 patients with diabetes mellitus (DM) who underwent transtibial amputation (TTA) for chronic infections and nonreconstructable lower extremity deformities. A secondary aim was to compare the outcomes of TTA patients with end-stage renal disease on dialysis (ESRD) to patients without ESRD, and to identify risk factors for mortality after TTA. METHODS: This cohort involved a consecutive series of patients who were treated by a single surgeon. The TTA patients were divided into 2 groups for analysis. The study group included those patients with ESRD who underwent TTA, and the control group included those patients who did not have ESRD. RESULTS: At the time of final follow-up, 64 of 102 patients were ambulatory with a prosthesis. There was a significant improvement in ambulatory status after amputation (preoperatively 45.1%, postoperatively 62.7%, P = .02). Wound healing complications (infection and/or dehiscence) occurred in 31 of 102 patients and led to a transfemoral amputation in 4 patients. After TTA patients with ESRD were significantly more likely to die (52.4% vs. 23.5%, p <0.05) and significantly less like to ambulate (42.9% vs. 67.9%, p <0.05) than patients without ESRD. Contralateral foot problems after the TTA occurred in 33 of 97 patients and resulted in 10 patients undergoing a contralateral transtibial amputation. Excluding patients with bilateral amputations (5 prior to and 10 after the index amputation), 64 of 87 patients with successful unilateral transtibial amputations were able to ambulate with a prosthesis. Thirty of 102 patients (29.4%) died during the follow-up period, and 6 of these deaths occurred during the perioperative period (within 30 days of surgery). There were no significant differences between the 2 groups with regard to the use of staged TTA, need for transfemoral amputation, or wound healing problems at the amputation site. Patients who were unable to walk postoperatively had a calculated 5-year survival rate of 30.1%, whereas those who were ambulatory had a 5-year survival rate of 68.8%. Cox proportional hazards model demonstrated a 62% reduced risk of mortality in patients who were able to ambulate after LEA compared with those patients who were not able to ambulate. CONCLUSION: TTA in patients with diabetes was associated with substantial morbidity and mortality. Risk factors that were significantly associated with an increased rate of mortality were the presence of ESRD, age ≥56 years, and inability to ambulate postoperatively. LEVEL OF EVIDENCE: Level III, retrospective case controlled study.

Comparison of Outcomes for Normal Saline and an Antiseptic Solution for Negative-Pressure Wound Therapy with Instillation.

BACKGROUND: Negative-pressure wound therapy with instillation is an adjunctive treatment that uses periodic instillation of a solution and negative pressure for a wide diversity of wounds. A variety of solutions have been reported, with topical antiseptics as the most frequently chosen option. The objective of this study was to compare the outcomes of normal saline versus an antiseptic solution for negative-pressure wound therapy with instillation for the adjunctive treatment of infected wounds. METHODS: This was a prospective, randomized, effectiveness study comparing 0.9% normal saline versus 0.1% polyhexanide plus 0.1% betaine for the adjunctive treatment of infected wounds that required hospital admission and operative débridement. One hundred twenty-three patients were eligible, with 100 patients randomized for the intention-to-treat analysis and 83 patients for the per-protocol analysis. The surrogate outcomes measured were number of operative visits, length of hospital stay, time to final surgical procedure, proportion of closed or covered wounds, and proportion of wounds that remained closed or covered at the 30-day follow-up. RESULTS: There were no statistically significant differences in the demographic profiles in the two cohorts except for a larger proportion of male patients (p = 0.004). There was no statistically significant difference in the surrogate outcomes with the exception of the time to final surgical procedure favoring normal saline (p = 0.038). CONCLUSION: The authors' results suggest that 0.9% normal saline may be as effective as an antiseptic (0.1% polyhexanide plus 0.1% betaine) for negative-pressure wound therapy with instillation for the adjunctive inpatient management of infected wounds. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

The impact of negative-pressure wound therapy with instillation compared with standard negative-pressure wound therapy: a retrospective, historical, cohort, controlled study.

BACKGROUND: Negative-pressure wound therapy with instillation is a novel wound therapy that combines negative pressure with instillation of a topical solution. METHODS: This retrospective, historical, cohort-control study examined the impact of negative-pressure wound therapy with and without instillation. RESULTS: One hundred forty-two patients (negative-pressure wound therapy, n = 74; therapy with instillation, 6-minute dwell time, n = 34; and therapy with instillation, 20-minute dwell time, n = 34) were included in the analysis. Number of operative visits was significantly lower for the 6- and 20-minute dwell time groups (2.4 ± 0.9 and 2.6 ± 0.9, respectively) compared with the no-instillation group (3.0 ± 0.9) (p ≤ 0.05). Hospital stay was significantly shorter for the 20-minute dwell time group (11.4 ± 5.1 days) compared with the no-instillation group (14.92 ± 9.23 days) (p ≤ 0.05). Time to final surgical procedure was significantly shorter for the 6- and 20-minute dwell time groups (7.8 ± 5.2 and 7.5 ± 3.1 days, respectively) compared with the no-instillation group (9.23 ± 5.2 days) (p ≤ 0.05). Percentage of wounds closed before discharge and culture improvement for Gram-positive bacteria was significantly higher for the 6-minute dwell time group (94 and 90 percent, respectively) compared with the no-instillation group (62 and 63 percent, respectively) (p ≤ 0.05). CONCLUSION: The authors' results suggest that negative-pressure wound therapy with instillation (6- or 20-minute dwell time) is more beneficial than standard negative-pressure wound therapy for the adjunctive treatment of acutely and chronically infected wounds that require hospital admission. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Negative-pressure wound therapy with instillation: international consensus guidelines.

BACKGROUND: Negative-pressure wound therapy with instillation is increasingly utilized as an adjunct therapy for a wide variety of wounds. Despite its growing popularity, there is a paucity of evidence and lack of guidance to provide effective use of this therapy. METHODS: A panel of experts was convened to provide guidance regarding the appropriate use of negative-pressure wound therapy with instillation. A face-to-face meeting was held where the available evidence was discussed and individual clinical experience with this therapy was shared. Follow-up communication among the panelists continued until consensus was achieved. The final consensus recommendations were derived through more than 80 percent agreement among the panelists. RESULTS: Nine consensus statements were generated that address the appropriate use of negative-pressure wound therapy with instillation. The question of clinical effectiveness of this therapy was not directly addressed by the consensus panel. CONCLUSION: This document serves as preliminary guidelines until more robust evidence emerges that will support or modify these consensus recommendations.