scholarly journals A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers

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


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.


2020 ◽  
Vol 9 (1) ◽  
pp. 23-34 ◽  
Author(s):  
Thomas E Serena ◽  
Raphael Yaakov ◽  
Sarah Moore ◽  
Windy Cole ◽  
Stacey Coe ◽  
...  

Aim: Determine the effectiveness of hypothermically stored amniotic membrane (HSAM) versus standard of care (SOC) in diabetic foot ulcers (DFUs). Methods: A randomized controlled trial was conducted on 76 DFUs analyzed digitally. Results: Cox wound closure for HSAM (38 wounds) was significantly greater (p = 0.04) at weeks 12 (60 vs 38%), and 16 (63 vs 38%). The probability of wound closure increased by 75% (Hazard Ratio = 1.75; 95% CI: 1.16–2.70). HSAM showed >60% reductions in area (82 vs 58%; p = 0.02) and depth (65 vs 39%; p = 0.04) versus SOC. Conclusion: HSAM increased frequency and probability of wound closure in DFUs versus SOC.


2018 ◽  
Vol 27 (12) ◽  
pp. 806-815
Author(s):  
Mónica Rodríguez Valiente ◽  
Francisco J. Nicolás ◽  
Ana M. García-Hernández ◽  
Cristina Fuente Mora ◽  
Miguel Blanquer ◽  
...  

2020 ◽  
Vol 23 ◽  
pp. S110
Author(s):  
T.E. Serena ◽  
R. Yaakov ◽  
S. Moore ◽  
W. Cole ◽  
S. Coe ◽  
...  

2016 ◽  
Vol 106 (5) ◽  
pp. 328-337 ◽  
Author(s):  
Barry I. Rosenblum

Background: Foot ulcers are among the most serious complications of diabetes and can lead to amputation. Diabetic foot ulcers (DFUs) often fail to heal with standard wound care, thereby making new treatments necessary. This case series describes the addition of a dehydrated amniotic membrane allograft (DAMA) to standard care in unresolved DFUs. Methods: This is a single-center retrospective chart review of eight patients who had one to three applications of DAMA to nine DFUs that had failed to resolve despite offloading, other standard care, and adjuvant therapies. Following initial DAMA placement, wound size (length, width, depth) was measured every 1 to 2 weeks until closure. The principal outcome assessed was mean time to wound closure; other outcomes included mean percent reduction from baseline in wound area and volume at weeks 2 to 8. Results: All wounds were closed a mean of 9.2 weeks after the first DAMA application (range, 3.0–13.5 weeks). Compared with baseline, wound area and volume, respectively, were reduced by a mean of 48% and 60% at week 2 and by 89% and 91% at week 8. Time to closure was shorter among four patients who had three DAMA applications (mean, 8.3 weeks; range, 4.0–11.0 weeks) than among three patients who had only one application (mean, 12.1 weeks; range, 9.5–13.5 weeks). Conclusions: Chronic, unresolved DFUs treated with DAMA rapidly improved and reached closure in an average of 9.2 weeks. These cases suggest that DAMA can facilitate closure of DFUs that have failed to respond to standard treatments.


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