scholarly journals Comparative effectiveness of a human fibroblast-derived dermal substitute and a viable cryopreserved placental membrane for the treatment of diabetic foot ulcers

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 (Sup5) ◽  
pp. S7-S14
Author(s):  
Thomas E Serena ◽  
Neal M Bullock ◽  
Windy Cole ◽  
John Lantis ◽  
Lam Li ◽  
...  

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.


Author(s):  
Silvia M Becerra-Bayona ◽  
Víctor Alfonso Solarte-David ◽  
Claudia L Sossa ◽  
Ligia C Mateus ◽  
Martha Villamil ◽  
...  

Summary Diabetic foot ulcer morbidity and mortality are dramatically increasing worldwide, reinforcing the urgency to propose more effective interventions to treat such a devastating condition. Previously, using a diabetic mouse model, we demonstrated that administration of bone marrow mesenchymal stem cells derivatives is more effective than the use of bone marrow mesenchymal stem cells alone. Here, we used the aforementioned treatments on three patients with grade 2 diabetic foot ulcers and assessed their beneficial effects, relative to the conventional approach. In the present study, two doses of cell derivatives, one dose of mesenchymal stem cells or one dose of vehicle (saline solution with 5% of human albumin), were intradermally injected around wounds. Wound healing process and changes on re-epithelialization were macroscopically evaluated until complete closure of the ulcers. All ulcers were simultaneously treated with conventional treatment (PolyMen® dressing). Patients treated with either cell derivatives or mesenchymal stem cells achieved higher percentages of wound closure in shorter times, relative to the patient treated with the conventional treatment. The cell derivative and mesenchymal stem cells approaches resulted in complete wound closure and enhanced skin regeneration at some point between days 35 and 42, although no differences between these two treatments were observed. Moreover, wounds treated with the conventional treatment healed after 161 days. Intradermal administration of cell derivatives improved wound healing to a similar extent as mesenchymal stem cells. Thus, our results suggest that mesenchymal stem cell derivatives may serve as a novel and potential therapeutic approach to treat diabetic foot ulcers. Learning points: In diabetic mouse models, the administration of mesenchymal stem cells derivatives have been demonstrated to be more effective than the use of marrow mesenchymal stem cells alone. Mesenchymal stem cells have been explored as an attractive therapeutic option to treat non-healing ulcers. Mesenchymal stem cells derivatives accelerate the re-epithelialization on diabetic foot ulcers.


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.


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