Poster session 9: Wound healing P9.01 An assessment of intralesional epidermal growth factor for treating diabetic foot wounds: the first experiences in Turkey Bulent Ertugrul, University of Adnan Menderes School of Medicine, Aydın, Turkey Benjamin A. Lipsky, University of Oxford & University of Geneva, Oxford, United Kingdom Turkish Study Group of Intralesional Epidermal Growth Factor, University of Adnan Menderes School of Medicine, Aydın, Turkey Intralesional EGF was newly registered as a medication in Turkey in 2012. We present the results of our experience using intralesional EGF in Turkey for patients with a diabetic foot wound. Between January 2012 and December 2013 we found a total of 174 patients from 25 Turkish medical centres who were evaluable for this retrospective study. We recorded the data on enrolled subjects in custom-designed patient follow-up forms. The application site for EGF was first cleansed, then debrided of any necrotic or infected soft-tissues and any infected bone. Then, patients received intralesional injections of 75 µg EGF three times per week on alternate days. Patients were monitored daily for any adverse reactions to their treatment. The patients were followed-up for varying periods after termination of their EGF treatments. Most patients were late middle-aged men who had their foot ulcer for about 3 months. Median treatment duration was 4 weeks and median frequency of EGF administration was 12 doses. Complete response (granulation tissue >75% or wound closure) was observed in 116 (66.7%) patients (Table 1)., The number of the patients whose wounds closed with only EGF administration was 81 (46.6%) while the number of patients whose wound closure occurred in conjunction with various surgical interventions, following EGF administration was 65 (37.3%). Overall, a total of 146 (83.9%) of the evaluable patients’ wounds were closed at the end of therapy (Table 1). At the end of treatment, 5 patients (2 9%), required major amputation. A total of 148 patients were followed up during the study period., Recurrence of the ulcer on treatment site was observed in 12 patients (8 1%) during follow-up. Adverse effects following EGF applications were reported in 97 patients (55.7%). This trial suggests that in patients with diabetic foot ulcer who received standard care, additional intralesional EGF application following infection control provides high healing rates with low amputation rates. Meanwhile, in patients with adequate granulation tissue on the ulcer site, performing surgical wound closure procedures may be a rational approach instead of waiting for the response to EGF alone. www.diabeticfoot.nl Page 1 of 11 www.diabeticfoot.nl Page 2 of 11 P9.02 The effect and potential mechanism of VEGF on skeletal muscle fibers and diabetic foot ulcer Lijing Jia, Institute of Basic Medicine Science, Chinese PLA General Hospital, Beijing, China Treatment of diabetic foot is a world-wide medical problem. Angiogenesis is the most key and main problem which should be solved in the process of diabetic foot therapy. Current treatments mostly concentrate on improving local micro-circulation and blood supply and functions of vascular endothelial cell. However, the study of the mechanism in the effects of musculofibers on wound healing remians elusive. As we know, there are mainly two phenotypes of striated skeletal muscle fibers: glycolytic and oxidative fiber, the latter owns higher oxidative mechanism and oxygen delivery capacity.Our hypothesis is increased oxidative musculofiber provides faster tissue healing. The aim of this study is to observe the effect and the mechanism of vascular endothelial growth factor(VEGF) on skeletal muscle fiber transformation and angiogenesis. Thus, we indentify that increased oxidative musculofiber provides faster tissue healing. In this study, we observe the fiber type composition and capillary density in both exercise and non-exercise mouse model by immunofluorescence with an antibody against the endothelial cell marker CD31, MHC I antibody and MHC IIa antibody.Meanwhile, the concentration of VEGF in muscle is detected by ELISA.Then we determine that whether VEGF can drive fiber type switching and induce angiogenesis following VEGF delivery in vitro and vivo and investigate the mitochondrial number and the level of glucose uptake. Moreover, using animal models, we identify that if the increase of oxidative musculofibers have positive effect on wound healing.We find that endurance exercise resulted in a significant increase in capillary density and glycolytic to oxidative muscle fiber switching. Similary, VEGF can also induce these changs and during this process the mitochondrial number and the level of glucose uptake increases.These findings suggest that the VEGF can induce muscle fiber transformation and angiogenesis, and this was likely mediated by mitochondrial biogenesis and improved glycometabolism which play a key role in microenvironmet for angiogenesis.We believe this study will provide further treatment choices to diabetic foot ulcer in clinical work. This study was supported by the National Natural Science Foundation of China(81100591). www.diabeticfoot.nl Page 3 of 11 P9.03 Split-thickness skin grafting compared to epidermal harvesting in the treatment of diabetic foot wounds: A literature review Margot Waldman, Mercy St Vincent Hospital, Perrysburg, OHIO, United States Aim: In recent decades, there has been an increase in the need for wound care, especially in diabetic patients. Using autografts instead of conservative wound dressings has proven to be very reliable and can produce astonishing results. This is a literature review that compares the traditional method of a split-thickness skin grafting with a new device that uses epidermal suction blisters to treat non-healing diabetic wounds. Methods: There is an extensive collection of research on the use of split thickness skin grafts on a variety of wounds. In examining multiple research studies, it shows that split thickness skin grafts can lead to a healed wound in a compliant patient. A new device [Cellutome™] produces epidermal suction blisters and can aid in diabetic foot wounds. Due to the extreme novelty of this product, there is limited research currently available on this specific device. However, multiple studies are being conducted at this time in the United States to explore this product. Results: Split thickness skin grafts have multiple guidelines that a patient has to achieve before they will be considered for a graft placement. The graft must be done in a sterile operative room setting and, after application, has a risk of complications that can include hematomas, need for re-grafting, and pigmentation changes at the donor sites. Research has shown that, with patient compliance, chances of the graft taking to the wound and healing can be good. The new device also has specific guidelines that must be met before application, but its aim is to treat wounds in a shorter amount of time, without the use of anesthesia, and claims to have lower complication risks than the traditional approach. The current studies of the novel device appear to be impressive, with excellent results for both the patient and physician. Conclusions: Split thickness skin grafts have had favorable outcomes in the reliable patient; however, it is possible that a “new kid in town” can outshine traditional grafting with new technology. Epidermal harvesting appears to be favorable in reduction of possible postoperative complications, decrease in healing time, and ease of application. www.diabeticfoot.nl Page 4 of 11 P9.04 An investigation of the effectiveness of a dressing of sodium carboxymethylcellulose with regenerated cellulose on diabetic foot ulcers Pauline Wilson, St James' Hospital, Dublin, Ireland Mark Dooley, St. James' Hospital, Dublin, Ireland Meave Corcoran, St. James' Hospital, Dublin, Ireland Aims: The Aim of this case series was to evaluate the use of a new formulation of a dressing of Sodium Carboxymethyl Cellulose with Regenerated Cellulose fibres, (SCMCRCF) as a treatment modality in the management of diabetic foot ulceration in a Podiatry led Diabetic Foot Clinic. This case series considers the ability of SCMC-RCF to decrease wound size, to decrease slough, to increase granulation and to manage exudate. Methods: 10 Patients were recruited from the Diabetic Foot Clinic with a wound that clinicians perceived would benefit from the properties of the SCMC-RCF dressing. At each treatment episode, the wound was inspected, cleaned and sharp debrided as per standard practice. SCMC-RCF was then applied to the area. This was covered with a secondary dressing and secured with tape. Results: The aims of the SCMC-RCF dressing as described were achieved in each of the 10 cases. Conclusion: This case series suggests that the SCMC-RDF dressing, in conjunction with standard care can increase healing rates and reduce healing time. The authors believe that in the moderate to heavily exuding wound the use of SCMC-RCF dressings enabled them to reduce the number of dressing changes required by individual patients thus reducing Health Care worker time and associated costs. We also feel that the use of this product may have a positive impact on the quality of life for patients. We feel that consideration should be paid to Quality adjusted life years (QALY) as well as Healthcare worker time warrants further investigation. www.diabeticfoot.nl Page 5 of 11 P9.05 Skin grafts and tissue replacements in the treatment of diabetic foot ulcers: the ultimate cover? Katrien Santema, AMC, Amsterdam, Netherlands Paul Poyck, AMC, Amsterdam, Netherlands Dirk Ubbink, AMC, Amsterdam, Netherlands Aim: Despite the many strategies available to treat diabetic foot ulcers, not all ulcers achieve complete healing. Additional treatments with skin grafts and tissue replacement products have been developed to promote complete wound closure by covering the skin defect. We systematically reviewed the effectiveness of skin grafts and tissue replacement products in addition to standard care for diabetic foot ulcers. Methods: In our Cochrane review we included all available evidence from randomised clinical trials performed worldwide. Study selection, data extraction and quality assessment were carried out independently by two review authors. Results: Fifteen of the 265 identified publications were eligible, and included 1488 randomised participants. Twelve trials compared a skin graft or tissue replacement with standard care. The remaining three trials compared two types of tissue replacement products. Most trials assessed the effectiveness of a cultured human dermal replacement consisting of dermal matrix proteins and fibroblasts. Pooled results showed that tissue replacements increased ulcer healing rate compared to standard care (RR 1.50, 95% CI 1.30 to 1.73; RD 0.23, 95% CI 0.14 to 0.32; NNT 6, 95% CI 5 to 9). No significant difference in healing rate was shown by one of the three studies that compared two types of tissue replacement products. Furthermore, no statistical differences were found for time to complete ulcer healing and recurrence. Conclusions: Current best available evidence shows that skin grafts and tissue replacements can increase the healing rate of diabetic foot ulcers when used in conjunction with standard care. However, long term results are not yet available and cost-effectiveness is uncertain. www.diabeticfoot.nl Page 6 of 11 P9.06 Chronic non-healing wound closures and amputation prevention: A comprehensive prospective case report and scrutiny of a novel allograft Tammer Elmarsafi, Medstar Washington Hospital Center, Washington, DC, United States John S. Steinberg, MedStar Washington Hospital Center, Washington, DC, United States Aims: 1: Demonstrate the importance of a multimodal approach to maximize favorable Limb Salvage outcomes in complex wounds. 2: Examine the efficacy and ease of use of a novel bioengineered alternative tissue allograft in two year chronic foot ulcer. Methodology: This is an institutional compliant, single-center, prospective case report with incorporated retrospective chart analysis. The duration of the prospective analysis is 37 weeks. A comprehensive retrospective chart review begins at the patient’s sentinel podiatric crisis. Definitive multimodal interventions are examined Prospectively; 92 weeks of review. This case report covers a total of 129 weeks. Procedures: Multi-staged operative management included surgical debridement, osseous resection for ulcer eradication, Peroneus brevis transfer and biotenodesis, and Achilles tendon and Tibialis anterior tendon lengthenings, with outpatient wound management utilizing a novel bioengineered alternative tissue allograft. Results: Surgical and postoperative wound management therapies yielded complete resolution of, a lateral ulceration [time to closure= 15 days], and 99% closure of the dorsal wound in 22 weeks; from 5.6cm x 2.3cm x 0.2cm to 0.5cm x 0.1cm x 0.1cm. Results of previous failed interventions are discussed., The use of the placental membrane matrix was well suited for this patient, easy to use, and offered optimal results in the first applications. This was however followed by plateau of wound closure velocity. It did yield the highest success than with 3 other previously used products in treating a 2 year intractable ulcer. Conclusions: Use of definitive comprehensive multi-staged surgical correction resulted in eradication of lateral ulcer etiology and a plantigrade foot., Surgical correction was crucial in the closure of these wounds. The addition of advanced wound management plan resulted in 100% sustained closure of a lateral wound and 99% reduction of a 2 year old non-healing dorsal wound. Results required 14 applications of a novel bioengineered allograft consisting of a cryopreserved placental membrane matrix when all other means failed. www.diabeticfoot.nl Page 7 of 11 P9.07 Use of a new gel-like dermal matrix for the treatment of diabetic foot ulcers: efficacy study on complicated lower limb lesions Luca Dalla Paola, Maria Cecilia Hospital, Cotignola, Italy Anna Carone, Maria Cecilia Hospital, Cotignola, Italy Maria Catena Principato, Maria Cecilia Hospital, Cotignola, Italy Marco Pattavina, Maria Cecilia Hospital, Cotignola, Italy Aim: Limb salvage may be a challenging problem in diabetic population affected by foot ulcers. In presence of infection progression surgical procedures becomes an essential treatment to save limbs. Cellular or acellular dermal substitutes are used both for covering lesions after, surgical debridement without primary intention closure, or in the case of dehiscence of the surgical site. Gel-like dermal matrix* is a dermal substitute developed for use when the geometry and localization of a lesion and/or the exposure of deep tissue does not allow the use of dermal substitute sheet. Method: From June 2013 to October 2014, 71 consecutive diabetic patients with foot ulcerations were enrolled. 25 patients had lesions resulting from an open minor amputation, 21 patients had open ostectomy with residual exposure of cancellous bone, 10 patients had dehiscence of the surgical site and 15 patients had deep wounds. All the lesions listed were staged as grade III B-D according to the classification of the University of Texas. Results / Discussion: The average follow up was 184 08±130 09 days. 44 (61 97%) patients healed with complete re-epithelialization of the lesion. Of these, 25 patients received simultaneous treatment with application of gel-like dermal matrix* and skin grafting, 4 patients were treated with delayed skin grafting after application of the dermal substitute. 16 (22 54%) patients showed an improvement of local conditions through cover of the exposed bone. 11 (15 49%) patients showed no improvement in relation to recurrence of infection and/or critical ischemia. Conclusion: The use of this gel-like dermal matrix* can be considered an affective treatment for diabetic foot wounds added to a program of multidisciplinary therapy. Integra®flowable wound matrix www.diabeticfoot.nl Page 8 of 11 P9.08 The effects of Hyperbaric Oxygen Therapy (HBOT) as adjunctive treatment for diabetic foot ulcers Luinio Tongson, Dr. James G. Dy Wound Healing and Diabetic Foot Center, Manila, Philippines Diabetic foot is associated with lower limb amputation and poor quality of life. The use of Hyperbaric Oxygen Therapy (HBOT) increases the success rate of healing diabetic foot wounds and decreases the incidence of lower extremity amputation. Objective: This study aims to evaluate the effects of HBOT on the healing of diabetic foot wounds, and determine the major amputation rate of diabetic foot patients treated with HBOT. Methodology: This prospective cross-sectional study was conducted at a Wound Healing and Diabetic Foot Center. Ninety-nine patients with diabetic foot Wagner 3 and Wagner 4 ulcers were given HBOT at 2.5 ATA (atmospheric pressure), 90 minutes a day, 5 days a week, as adjunctive therapy. At the end of the treatment, the ulcers were evaluated. Results: Twenty-five patients who received less than six sessions of HBOT were excluded in the study. There were 44 males and 30 females, aged 39 to 97, with a mean age of 63. They received between 6 and 30 HBOT sessions, with an average of 14. Sixty-seven patients (91%) who underwent HBOT had the wound improved while seven patients (9%) underwent major amputation. Among the 67 patients who improved on HBOT, 59 (88%) had complete healing of the diabetic wound. The other 8 patients (12%) had incomplete healing but with improvement. There were 7 patients who underwent major amputation, 2 with Wagner 3 lesions and 5 with Wagner 4 lesions. Conclusion:Treatment of diabetic foot wounds with an aggressive, multidisciplinary therapeutic protocol in conjunction with hyperbaric oxygen treatment is effective in decreasing major amputations. The preliminary result of the study is promising, but large randomized controlled trials are necessary in order to establish the efficacy of HBOT in the treatment of diabetic foot. www.diabeticfoot.nl Page 9 of 11 P9.09 Hyperbaric oxygen therapy seems to preserve renal function in patients with diabetes and hard-to-heal foot ulcers Katarina Fagher, Skåne University Hospital, Lund, Sweden Per Katzman, Skåne University Hospital, Lund, Sweden Magnus Londahl, Skane University Hospital, Lund, Sweden Aim: Systemic hyperbaric oxygen therapy (HBO), a medical treatment for hard-to-heal diabetic foot ulcers, has been demonstrated to increase oxygenation in hypoxic tissue and might enhance microvascular function. Whether HBO has any effects on renal function has to our knowledge previously not been evaluated in humans. The aim of this study was to evaluate the effect of HBO on estimated glomerular filtration rate (eGFR) and urine albumin/creatinine ratio (UACR) in patients with diabetes and hard-to-heal foot ulcers. Methods: In a prospective randomised double-blinded placebo-controlled study effects of HBO was evaluated. Patients were randomised to 40 treatment sessions with either oxygen or air, at 2.5 ATA. Patients fulfilling (per-protocol requirement) at least 36 completed treatment sessions were included. UACR and eGFR based on serum creatinine were evaluated before and at the one-year follow-up. Patients with end stage renal disease, defined as eGFR <15 ml min-1 1.73 m-2 or on-going dialysis at baseline were excluded from analysis. Further, UACR values analysed during acute urinary tract infections or use of urinary catheter, were excluded. Non-parametric statistics were used and a two-sided p<0.05 was considered as statistical significant. Data are given as median (interquartile range). Results: 75 patients (38 HBO / 37 placebo) completed at least 36 treatment sessions. Of these, 3 were on dialysis and 4 died before follow-up. Accordingly, 68 patients (35 HBO / 33 placebo) could be evaluated. UACR at baseline and 1 year follow-up was only available in 39 (19 vs. 20) patients. Baseline characteristics as well as treatment with renin-angiotensin system inhibitors were similar. Among HBO treated patient at 1-year follow-up there was a statistical significant increase in eGFR (67.0 (43.3-92.9) vs 68.1 (39.8-91.6), p=0.04) and a decrease in UACR (75 (12-165) vs 21 (5-63) g/mol, p=0.005), while eGFR (58.9 (39.6-82.7) vs. 57.3 (35.871.7), p=0.09) as well as UACR (30 (5-59) vs 30 (3-124) g/mol, n.s) were similar among placebo treated patients. Conclusions: HBO treatment might have beneficial effects on renal function in patients with diabetes and hard-to-heal foot ulcers. www.diabeticfoot.nl Page 10 of 11 P9.10 NO-air-plasma currents and ozone therapy in treatment of patients with diabetic foot syndrome Vladimir Obolenskiy, City Hospital #13, RNRMU, Moscow, Russia Alexander Molotschnikov, City Hospital #13, Moscow, Russia Aim: to determine the effect of joint use of NO-air-plasma currents (APC) and ozone therapy (OT) on cellular elements and the level of bacteriological contamination of wounds occurring as a result of diabetic foot syndrome (DFS). Methods: A total of 160 patients suffering from purulo-necrotic feet wounds arising from DFS. Patients’ average age was 63 9+9 7 years, with men slightly outnumbering women, 57 1 vs. 42 9%, respectively. Predominant conditions neuro-ischemic form of DFS (>87%). The main group consisted of 57 (35 6%) patients that underwent corrective surgery on major vessels of lower limbs and treated daily with APC and OT. The wound then was dressed with water-soluble ointment. The first control group consisted of 75 (46 9%) patients that did not undergo corrective surgery on major vessels of lower limbs, the second group consisted of 28 (17 5%) patients with corrective vascular measures. Treatment in these groups involved daily changes of wound dressings and application of water-soluble ointment. Results: Proliferation activity of fibroblastic cells, collagenogenesis and mitotic activity of epithelial cells in the main group exceeded the same indexes in the first control group more than two times and more than 1 5 times in the second control group. Microbiological contamination of wound in the main group on the 4-5 day declined down to 103-105 CFM/cm2, however in both control groups this score remained >105 for up to 12 days. Conclusion: Sequenced application of APC and OT in treatment of patients with DFS is characterized with pronounced bactericidal effect and boosts epithelialization process, making it two times faster. *) «Plazon» & UOTA 60-01 «Medozon»; made in Russia. www.diabeticfoot.nl Page 11 of 11
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