Ease of Use, Safety, and Efficacy of Integra Bilayer Wound Matrix in the Treatment of Diabetic Foot Ulcers in an Outpatient Clinical Setting

2013 ◽  
Vol 103 (4) ◽  
pp. 274-280 ◽  
Author(s):  
Min Yao ◽  
Khaled Attalla ◽  
Yanhan Ren ◽  
Michael A. French ◽  
Vickie R. Driver
Keyword(s):  
Clinical Setting ◽  
Diabetic Foot ◽  
Ease Of Use ◽  
Foot Ulcers ◽  
Inpatient Setting ◽  
Diabetic Foot Ulcers ◽  
Plantar Aspect ◽  
Wound Matrix ◽  
Recurrent Ulcers

Background: Integra bilayer wound matrix (IBWM) is a bilayer skin replacement system composed of a dermal regeneration layer and a temporary epidermal layer. It is used to treat various types of deep, large wounds via an inpatient procedure in an operating room. We sought to determine ease of use and effectiveness of IBWM in an outpatient clinical setting when treating diabetic foot ulcers. In addition, no epidermal autografting was performed in conjunction with the IBWM after silicone release, as is common in the inpatient setting. Methods: This 12-week, single-arm, prospective pilot study was conducted in three outpatient clinics. Weekly evaluations included monitoring the wound for signs of infection during the 12-week follow-up phase. Results: Eleven patients with diabetic foot ulcers who met the inclusion and exclusion criteria were enrolled. One patient was discontinued from the study owing to noncompliance leading to a serious adverse event. Therefore, ten patients who received the study intervention were included in the per-protocol population reported herein. The mean patient age was 60.6 years, with an average 11-year history of diabetes mellitus. Each ulcer was located on the plantar aspect of the foot. No infection was reported during the study. Patients treated with IBWM showed progressive wound healing over time: the greatest mean wound reduction was approximately 95% in week 12. Seven of ten patients (70%) achieved complete wound closure by week 12. No recurrent ulcers were reported during follow-up. Conclusions: These results are consistent with the hypothesis that IBWM is easy to use, safe, and effective when used on diabetic foot ulcers in an outpatient clinical setting without the secondary procedure of autografting for closure. (J Am Podiatr Med Assoc 103(4): 274–280, 2013)

Punch Grafting for the Management of Hard-to-Heal Diabetic Foot Ulcers: A Prospective Case Series

2021 ◽  
pp. 153473462110310
Author(s):  
Marta García-Madrid ◽  
Irene Sanz-Corbalán ◽  
Aroa Tardáguila-García ◽  
Raúl J. Molines-Barroso ◽  
Mateo López-Moral ◽  
...  
Keyword(s):  
Wound Healing ◽  
Clinical Outcomes ◽  
Diabetic Foot ◽  
Donor Site ◽  
Case Series ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Wound Debridement ◽  
Prospective Case Series

Punch grafting is an alternative treatment to enhance wound healing which has been associated with promising clinical outcomes in various leg and foot wound types. We aimed to evaluate the clinical outcomes of punch grafting as a treatment for hard-to-heal diabetic foot ulcers (DFUs). Six patients with chronic neuropathic or neuroischemic DFUs with more than 6 months of evolution not responding to conventional treatment were included in a prospective case series between May 2017 and December 2020. All patients were previously debrided using an ultrasound-assisted wound debridement and then, grafted with 4 to 6 mm punch from the donor site that was in all cases the anterolateral aspect of the thigh. All patients were followed up weekly until wound healing. Four (66.7%) DFUs were located in the heel, 1 (16.7%) in the dorsal aspect of the foot and 1 (16.7%) in the Achilles tendon. The median evolution time was 172 (interquartile range [IQR], 25th-75th; 44-276) weeks with a median area of 5.9 (IQR; 1.87-37.12) cm2 before grafting. Complete epithelization was achieved in 3 (50%) patients at 12 weeks follow-up period with a mean time of 5.67 ± 2.88 weeks. Two of the remaining patients achieved wound healing at 32 and 24 weeks, respectively, and 1 patient showed punch graft unsuccessful in adhering. The median time of wound healing of all patients included in the study was 9.00 (IQR; 4.00-28.00) weeks. The wound area reduction (WAR) at 4 weeks was 38.66% and WAR at 12 weeks was 88.56%. No adverse effects related to the ulcer were registered through the follow-up period. Autologous punch graft is an easy procedure that promotes healing, achieving wound closure in chronic DFUs representing an alternative of treatment for hard-to-heal DFUs in which conservative treatment has been unsuccessful.

scholarly journals Wound Fluid Matrix Metalloproteinase-9 as a Potential Predictive Marker for the Poor Healing Outcome in Diabetic Foot Ulcers

2018 ◽  
Vol 2018 ◽  
pp. 1-5 ◽  
Author(s):  
Punyanuch Jindatanmanusan ◽  
Sivat Luanraksa ◽  
Tanit Boonsiri ◽  
Thirayost Nimmanon ◽  
Pasra Arnutti
Keyword(s):  
Wound Healing ◽  
G Protein ◽  
Diabetic Foot ◽  
Healing Process ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Wound Fluid ◽  
The Poor ◽  
Wound Size

Background and Objective. Evidence for the roles of matrix metalloproteinases-9 (MMP-9) in the healing process of diabetic foot ulcers has remained unclear. We therefore aimed to demonstrate the relationship of MMP-9 with the wound healing process and determine its potential usefulness in predicting the wound healing outcome. Methods. Twenty-two patients with diabetic foot ulcer were recruited. The wound size was determined, and the wound fluid was collected for the measurement of MMP-9 levels using an ELISA during the 12-week follow-up period regularly. The patients were categorized as good healers and poor healers when the wound area reduction was ≥ 50% and < 50% at week 4 when compared to the initial wound size at week 0. Results. Median wound fluid MMP-9 levels in the poor healer group were shown to be significantly higher than those in the good healer group (1.03 pg/µg protein vs. 0.06 pg/µg protein, p = 0.001), and the levels fluctuated throughout the 12-week follow-up period. In contrast to the poor healer group, the MMP-9 levels were demonstrated to be constantly low throughout the follow-up period in the good healer group. ROC analysis showed that the MMP-9 level of 0.38 pg/µg protein was able to predict the wound healing outcome with the sensitivity of 81.8%, the specificity of 64.6%, and the area under the curve of 0.901 (CI 0.78-1.03, p = 0.001). Conclusion. These findings suggested that determination of wound fluid MMP-9 levels might become a promising biomarker predicting wound healing outcomes and a novel potential therapeutic target for diabetic foot ulcers.

scholarly journals Mortality in Patients with Diabetic Foot Ulcers: Causes, Risk Factors, and Their Association with Evolution and Severity of Ulcer

2020 ◽  
Vol 9 (9) ◽  
pp. 3009
Author(s):  
José Antonio Rubio ◽  
Sara Jiménez ◽  
José Luis Lázaro-Martínez
Keyword(s):  
Diabetic Foot ◽  
Cox Regression ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Cox Regression Analysis ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
History Of

Background: This study reviews the mortality of patients with diabetic foot ulcers (DFU) from the first consultation with a Multidisciplinary Diabetic Foot Team (MDFT) and analyzes the main cause of death, as well as the relevant clinical factors associated with survival. Methods: Data of 338 consecutive patients referred to the MDFT center for a new DFU during the 2008–2014 period were analyzed. Follow-up: until death or until 30 April 2020, for up to 12.2 years. Results: Clinical characteristics: median age was 71 years, 92.9% had type 2 diabetes, and about 50% had micro-macrovascular complications. Ulcer characteristics: Wagner grade 1–2 (82.3%), ischemic (49.2%), and infected ulcers (56.2%). During follow-up, 201 patients died (59.5%), 110 (54.7%) due to cardiovascular disease. Kaplan—Meier curves estimated a reduction in survival of 60% with a 95% confidence interval (95% CI), (54.7–65.3) at 5 years. Cox regression analysis adjusted to a multivariate model showed the following associations with mortality, with hazard ratios (HRs) (95% CI): age, 1.07 (1.05–1.08); HbA1c value < 7% (53 mmol/mol), 1.43 (1.02–2.0); active smoking, 1.59 (1.02–2.47); ischemic heart or cerebrovascular disease, 1.55 (1.15–2.11); chronic kidney disease, 1.86 (1.37–2.53); and ulcer severity (SINBAD system) 1.12 (1.02–1.26). Conclusion: Patients with a history of DFU have high mortality. Two less known predictors of mortality were identified: HbA1c value < 7% (53 mmol/mol) and ulcer severity.

Comparative study between Negative Pressure Wound Therapy (NPWT) and Standard Moist Wound Dressing (SMWD) in management of diabetic non ischemic foot ulcers

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
A M Kamal ◽  
A N Kamel ◽  
S M Elsayed
Keyword(s):  
Negative Pressure ◽  
Diabetic Foot ◽  
Negative Pressure Wound Therapy ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Wound Therapy ◽  
Significant Difference ◽  
Group A ◽  
Group B

Abstract Background and Aims Diabetes is rapidly increasing in prevalence worldwide and surgery in patients with diabetic foot is becoming more common. Foot complications are a major cause of admissions in diabetic patients, and comprise a disproportionately high number of hospital days because of multiple surgical procedures and prolonged length of stay in hospital. Diabetic foot is an umbrella term for foot problems in patients with diabetes mellitus. Foot disorders such as ulceration, infection and gangrene are the most common, complex and costly sequelae of diabetes mellitus. The optimal therapy for diabetic foot ulcers remains ill-defined. Saline-moistened gauze has been the standard method; however, it has been difficult to continuously maintain a moist wound environment with these dressings. This has led to the development of various hydrocolloid wound gels, which provided more consistent moisture retention. Refinements in topical ointments have resulted in the addition of various pharmacological agents including growth factors and enzymatic debridement compounds. Hyperbaric oxygen therapy and culture skin substitutes are other wound therapies that have been advocated. All these therapies are associated with significant expense and are being utilized in some situations without sufficient scientific evidence demonstrating their efficacy. Therefore, the search for an efficacious, convenient and cost-effective therapy continues. Negative Pressure Wound Therapy (NPWT) is a newer noninvasive adjunctive therapy system that uses controlled negative pressure using Vacuum-Assisted Closure device (VAC) to help promote wound healing by removing fluid from open wounds through a sealed dressing and tubing which is connected to a collection container. The use of sub-atmospheric pressure dressings, available commercially as a VAC device, has been shown to be an effective way to accelerate healing of various wounds. This was aimed to compare wound outcome, limb salvage, and cost effectiveness between Negative pressure wound therapy (NPWT) and Standard moist wound therapy (SMWT) in management of diabetic non ischemic foot ulcers. Methods we performed a cohort study involving 30 patients with active diabetic foot ulcers, in a high volume tertiary referral vascular center. They were divided into 2 groups: 15 patients (group A) were prescribed NPWT and the other 15 patients (group B) received SMWD. During follow up visits, progress of healing was evaluated and documented in the form of change in wound diameter, depth, up or down scaling along UTWC, wound status at 2, 4, 8, and 12 weeks and 4 weekly thereafter till complete epithelialization. Results As regard to ulcer depth there were statistically significant difference between the 2 groups during follow up duration of the study after 4 weeks with group A showing faster decrease in ulcer depth than group B denoting faster formation of granulation tissue. As regard to complete granulation of ulcer there were statistically significant difference between the 2 groups during follow up duration of the study markedly shown after 6 weeks with group A showing complete ulcer granulation faster than group B, with statistically significant difference as regard to number of days on dressing and follow up duration in weeks between the 2 groups with group A showing lesser number of days on dressing and shorter follow up duration in weeks than group B. Conclusion NPWT has a definitive role in promotion of proliferation of granulation tissue, reduction in the wound size, by and rapid clearing of bacterial load. Our data demonstrates that negative pressure wound dressings decrease the wound size more effectively than saline gauze dressings over the first 4 weeks of therapy. It is suggested that NPWT is a cost-effective, easy to use and patient-friendly method of treating diabetic foot ulcers which helps in early closure of wounds, preventing complications and hence promising a better outcome.

scholarly journals Long-Term Outcome and Disability of Diabetic Patients Hospitalized for Diabetic Foot Ulcers: A 6.5-year follow-up study

Diabetes Care ◽  
2008 ◽  
Vol 31 (7) ◽  
pp. 1288-1292 ◽  
Author(s):  
E. Ghanassia ◽  
L. Villon ◽  
J.-F. Thuan dit Dieudonne ◽  
C. Boegner ◽  
A. Avignon ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Foot Ulcers ◽  
Diabetic Patients ◽  
Diabetic Foot Ulcers ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Follow Up Study

Analysis of transfer lesions in patients who underwent surgery for diabetic foot ulcers located on the plantar aspect of the metatarsal heads

2013 ◽  
Vol 30 (8) ◽  
pp. 973-976 ◽  
Author(s):  
R. J. Molines-Barroso ◽  
J. L. Lázaro-Martínez ◽  
J. Aragón-Sánchez ◽  
E. García-Morales ◽  
J. V. Beneit-Montesinos ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Plantar Aspect

scholarly journals Randomized controlled clinical trial evaluating the efficacy of hyperbaric oxygen therapy in facilitating the healing of chronic foot ulcers in diabetic patients: the study protocol

2019 ◽  
Author(s):  
Jocefabia Reika Alves Lopes ◽  
Mariza D’Agostino Dias ◽  
João Antonio Correa ◽  
Maria Alice Bragagnolo Batalha ◽  
Luanda Karla Dantas Guerra
Keyword(s):  
Hyperbaric Oxygen ◽  
Diabetic Foot ◽  
Hyperbaric Oxygen Therapy ◽  
Oxygen Therapy ◽  
Standard Treatment ◽  
Foot Ulcers ◽  
Control Group ◽  
Diabetic Patients ◽  
Diabetic Foot Ulcers

Abstract Background: Diabetic limb ulcers are highly prevalent and contribute to a significant increase in cost for the treatment of these patients in health services. However, healing of these wounds is a major health problem and may even lead to amputation. The aim of the current study is to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) in facilitating the healing of diabetic foot ulcers and reducing the number of amputations in these patients.Methods : The study will be conducted in the city of Imperatriz, Maranhão from 2019 to 2020, in diabetic patients with chronic foot ulcers (classified as Wagner grade 2, 3, and 4, persisting for more than one month). The outpatient follow-up for diabetic foot patients will be done at the SUS (Unified Health System), with a sample size of 120 patients (60 patients for each arm). Half of the patients will receive standard treatment, i.e. dressings, debridement, antibiotics, and load relief, along with HBOT (HBOT group), and the other half will receive only standard treatment (control group). The patients of the HBOT group will be evaluated upon admission, after 10, 20, 30 and 35 HBOT sessions, and after six months. The patients of the control group will also be evaluated at equivalent periods. The progression of the wounds and specific treatment, such as appropriate bandage, antibiotic therapy, or need of some surgical intervention will be evaluated on a weekly basis. The SF-36 quality of life questionnaire will be filled upon admission and after three months of follow-up in both groups. Upon admission, the patients of both groups will undergo arterial Doppler ultrasound, and laboratory tests–complete blood count, erythrocyte sedimentation rate, C-reactive protein, creatinine, fasting blood glucose, and glycosylated haemoglobin.Discussion : Diabetic foot ulcers are a highly prevalent complication of diabetes with serious consequences. A study to assess the efficacy of HBOT in healing the ulcers and reducing the rate of amputations in diabetic patients is justified, which will eventually aid in the development of guidelines for treating these ulcers.

scholarly journals Randomized controlled clinical trial evaluating the efficacy of hyperbaric oxygen therapy in facilitating the healing of chronic foot ulcers in diabetic patients: the study protocol

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Jocefábia Reika Alves Lopes ◽  
Mariza D’Agostino Dias ◽  
João Antonio Correa ◽  
Maria Alice Bragagnolo Batalha ◽  
Luanda Karla Dantas Guerra
Keyword(s):  
Quality Of Life ◽  
Diabetic Foot ◽  
Oxygen Therapy ◽  
Standard Treatment ◽  
Foot Ulcers ◽  
Control Group ◽  
Diabetic Patients ◽  
Diabetic Foot Ulcers

Abstract Background Diabetic limb ulcers are highly prevalent and contribute to a significant increase in cost for the treatment of these patients in health services. However, healing of these wounds is a major health problem and may even lead to amputation. The primary aim of the current study is to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) in facilitating the healing of diabetic foot ulcers, in addition to secondarily evaluating whether it reduces the number of amputations and improves the quality of life in these patients. Methods A non-blind randomized clinical study will be conducted in the city of Imperatriz, Maranhão state, Brazil, from 2019 to 2020, in diabetic patients with chronic foot ulcers (classified as Wagner grades 2, 3 and 4, persisting for more than 1 month). The outpatient follow-up for diabetic foot patients will be done at the Unified Health System, with a sample size of 120 patients (the randomization allocation will be 1:1, being 60 patients for each arm). Half of the patients will receive standard treatment, i.e. dressings, debridement, antibiotics and load relief, along with HBOT (HBOT group), and the other half will receive only standard treatment (control group). The patients of the HBOT group will be evaluated upon admission, after 10, 20, 30 and 35 HBOT sessions, and after 6 months and 1 year. The patients of the control group will also be evaluated at equivalent periods (upon admission, after 2, 4, 6 and 7 weeks, 6 months and 1 year). The SF-36 quality of life questionnaire will be filled upon admission and after 3 months of follow-up in both groups. The primary and secondary endpoints will be assessed with 1 year of follow-up. Discussion Diabetic foot ulcers are a highly prevalent complication of diabetes with serious consequences. A study to assess the efficacy of HBOT in healing the ulcers and reducing the rate of amputations in diabetic patients is justified, which will eventually aid in the development of guidelines for treating these ulcers. Trial registration Registration number RBR-7bd3xy. Registered on 17 July 2019—Retrospectively registered.

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