scholarly journals A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers

2016 ◽  
Vol 14 (2) ◽  
pp. 307-315 ◽  
Author(s):  
Charles M Zelen ◽  
Dennis P Orgill ◽  
Thomas Serena ◽  
Robert Galiano ◽  
Marissa J Carter ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Standard Of Care ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Multicentre Clinical Trial ◽  
Human Dermis ◽  
Randomised Controlled

Use of a dual-layer amniotic membrane in the treatment of diabetic foot ulcers: an observational study

2020 ◽  
Vol 29 (Sup9) ◽  
pp. S8-S12
Author(s):  
Isabella Sledge ◽  
David Maislin ◽  
Dave Bernarducci ◽  
Robert Snyder ◽  
Thomas E Serena
Keyword(s):  
Clinical Trial ◽  
Sample Size ◽  
Primary Endpoint ◽  
Amniotic Membrane ◽  
Diabetic Foot ◽  
Standard Of Care ◽  
Small Sample ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Complete Closure

Background: Despite advances in the treatment, fewer than half of diabetic foot ulcers (DFUs) heal in 12 weeks and 85% of non-traumatic amputations follow the development of a DFU. The search for treatment options continues. Placental-derived products have shown promise in the treatment of DFUs. This study investigates Artacent (Tides Medical, US), a unique amniotic patch containing two layers of amnion and its potential to increase growth factor delivery. Method: This observational analysis included patients with DFUs with documented failure to heal by >50% after the protocol-defined run-in period (either two or four weeks) of standard of care (SOC), and who had been randomised in a larger clinical trial that had been discontinued earlier for logistical reasons. Patients were randomised to either weekly or biweekly application of the dual-layer amniotic membrane (DLAM) plus SOC and were included in per-protocol effectiveness analyses. Descriptive statistics were chosen for this analysis. Primary endpoint was complete closure at 12 weeks. Results: A total of 26 patients were included in the analysis. Examination of baseline patient characteristics revealed that the ulcers were larger than in most DFU clinical trials (4.65±4.89cm2). For the primary endpoint, 17/26 (65%, 95% CI: 44–83%) of the combined treatment arms achieved complete closure. The small sample size precluded a meaningful comparison of healing between weekly and biweekly DLAM applications. Conclusion: The observations taken from the discontinued clinical trial suggest that the DLAM promotes healing of DFUs. The healing rates are similar to those in other placental-based tissue studies. In addition, the relatively larger size of the ulcers suggests that the DLAM may be effective in ulcers that are more resistant to standard of care. In the future, a revised clinical trial with a greater sample size is planned.

scholarly journals An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow-up trial

2018 ◽  
Vol 15 (5) ◽  
pp. 731-739 ◽  
Author(s):  
Charles M Zelen ◽  
Dennis P Orgill ◽  
Thomas E Serena ◽  
Robert E Galiano ◽  
Marissa J Carter ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Human Dermis ◽  
Randomised Controlled

scholarly journals Emerging Diabetic Foot Ulcer Microbiome Analysis using Cutting Edge Technologies

2021 ◽  
pp. 193229682199009
Author(s):  
Brian M. Schmidt
Keyword(s):  
Diabetic Foot ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Standard Of Care ◽  
Molecular Techniques ◽  
Foot Ulcers ◽  
Care Practice ◽  
Antibiotic Administration ◽  
Diabetic Foot Ulcers ◽  
Conventional Culture

One of the most prevalent complications of diabetes mellitus are diabetic foot ulcers (DFU). Diabetic foot ulcers represent a complex condition placing individuals at-risk for major lower extremity amputations and are an independent predictor of patient mortality. DFU heal poorly when standard of care therapy is applied. In fact, wound healing occurs only approximately 30% within 12 weeks and only 45% regardless of time when standard of care is utilized. Similarly, diabetic foot infections occur in half of all DFU and conventional microbiologic cultures can take several days to process before a result is known. DFU represent a significant challenge in this regard because DFU often demonstrate polymicrobial growth, become resistant to preferred antibiotic therapy, and do not inform providers about long-term prognosis. In addition, conventional culture yields may be affected by the timing of antibiotic administration and collection of tissue for analysis. This may lead to suboptimal antibiotic administration or debilitating amputations. The microbiome of DFU is a new frontier to better understand the interactions between host organisms and pathogenic ones. Newer molecular techniques are readily available to assist in analyzing the constituency of the microbiome of DFU. These emerging techniques have already been used to study the microbiome of DFU and have clinical implications that may alter standard of care practice in the near future. Here emerging molecular techniques that can provide clinicians with rapid DFU-related-information and help prognosticate outcomes in this vulnerable patient population are presented.

Security and efficacy of intradermal injection of mesenchymal stem cells derivatives on chronic diabetic foot ulcers: a randomized controlled clinical trial

Cytotherapy ◽  
2021 ◽  
Vol 23 (5) ◽  
pp. S22
Author(s):  
S.M. Becerra-Bayona ◽  
V.A. Solarte-David ◽  
C.L. Sossa ◽  
L.C. Mateus ◽  
J. Pereira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Diabetic Foot ◽  
Intradermal Injection ◽  
Foot Ulcers ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled

Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial

2021 ◽  
Vol 30 (Sup5) ◽  
pp. S7-S14
Author(s):  
Thomas E Serena ◽  
Neal M Bullock ◽  
Windy Cole ◽  
John Lantis ◽  
Lam Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Diabetic Foot ◽  
Oxygen Therapy ◽  
Wound Closure ◽  
Foot Ulcers ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers ◽  
Open Label ◽  
Number Of Patients

Objectives: Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks). Method: This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events. Results: For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events. Conclusion: This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.

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