scholarly journals Comparative effectiveness of a bioengineered living cellular construct vs. a dehydrated human amniotic membrane allograft for the treatment of diabetic foot ulcers in a real world setting

2015 ◽  
Vol 23 (5) ◽  
pp. 737-744 ◽  
Author(s):  
Robert S. Kirsner ◽  
Michael L. Sabolinski ◽  
Nathan B. Parsons ◽  
Michelle Skornicki ◽  
William A. Marston
2020 ◽  
Vol 23 ◽  
pp. S110
Author(s):  
T.E. Serena ◽  
R. Yaakov ◽  
S. Moore ◽  
W. Cole ◽  
S. Coe ◽  
...  

2018 ◽  
Vol 26 (2) ◽  
pp. 213-220 ◽  
Author(s):  
Katherine M. Raspovic ◽  
Dane K. Wukich ◽  
Daniel Q. Naiman ◽  
Lawrence A. Lavery ◽  
Robert S. Kirsner ◽  
...  

Author(s):  
Brandon A. Bosque ◽  
Christopher Frampton ◽  
Abigail E. Chaffin ◽  
Gregory A. Bohn ◽  
Kevin Woo ◽  
...  

2020 ◽  
Vol 29 (Sup9) ◽  
pp. S8-S12
Author(s):  
Isabella Sledge ◽  
David Maislin ◽  
Dave Bernarducci ◽  
Robert Snyder ◽  
Thomas E Serena

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.


2013 ◽  
Vol 10 (5) ◽  
pp. 502-507 ◽  
Author(s):  
Charles M Zelen ◽  
Thomas E Serena ◽  
Guilhem Denoziere ◽  
Donald E Fetterolf

2019 ◽  
Vol 8 (14) ◽  
pp. 1229-1238
Author(s):  
Michael L Sabolinski ◽  
John V Capotorto

Objective: To compare a human fibroblast-derived dermal substitute (HFDS) to a viable cryopreserved placental membrane (vCPM) for use in diabetic foot ulcers (DFUs). Methods: An electronic medical record database of 1622 refractory DFUs with areas 1–40 cm2 was analyzed. Results: Cox estimates of wound closure for HFDS (1444 wounds) were significantly greater (p = 0.0002) by weeks 12 (31 vs 21%), 24 (55 vs 39%) and 36 (68 vs 51%) compared with vCPM (178 wounds). HFDS reduced the median time to wound closure by 55% compared with vCPM, (20 vs 36 weeks, p = 0.0002). HFDS also increased the probability of wound closure by 60% (hazard ratio = 1.60 [95% confidence interval, (1.25, 2.06)], p = 0.0002). Conclusion: HFDS improved time and frequency of wound closure in DFUs versus vCPM.


2021 ◽  
Vol 30 (Sup7) ◽  
pp. S47-S53
Author(s):  
Grace L Tsai ◽  
Daniel Zilberbrand ◽  
Wei Jei Liao ◽  
Lawrence P Horl

The treatment of diabetic foot ulcers is complex and costly with an increased risk for infection, which may even lead to amputation. This prospective case series aims to assess the effectiveness of a dehydrated amniotic membrane allograft combined with a bilayer dermal matrix for healing complicated foot ulcers in patients with comorbidities. A total of six patients with complicated full-thickness ulcers and comorbidities, such as diabetes and peripheral vascular disease were treated with this technique. Each wound was measured intraoperatively just before graft application, at 14 days after application, and then at weeks 4, 8, and 12. Changes in wound volume and area were compared over time. One patient had complete wound closure by week eight, a second patient by week 12. The other four patients had wounds that decreased in size during the course of 12 weeks. The mean decrease in wound volume was 73.5% post-removal of the bilayer dermal matrix after two weeks of application. At week 12, the mean decrease in wound area and volume were 93.2% and 97.1%, respectively. This case series provides initial evidence that the combination of dehydrated amniotic membrane allograft with bilayer dermal matrix promotes complete wound closure in patients with comorbidities that may impede wound healing. Further clinical trials are needed to confirm these results.


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