Literature DB >> 31691579

A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers.

Thomas E Serena1, Raphael Yaakov2, Sarah Moore2, Windy Cole3, Stacey Coe3, Rob Snyder4, Keyur Patel5, Bryan Doner5, Maria A Kasper6, Rachel Hamil2, Santina Wendling7, Michael L Sabolinski8.   

Abstract

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.

Entities:  

Keywords:  HSAM; clinical trials; diabetes; hypothermically stored amniotic membrane

Year:  2019        PMID： 31691579     DOI： 10.2217/cer-2019-0142

Source DB:  PubMed          Journal:  J Comp Eff Res        ISSN： 2042-6305            Impact factor:   1.744


  6 in total

1.  A multi-centre, single-blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of diabetic foot ulcers.

Authors:  David G Armstrong; Dennis P Orgill; Robert D Galiano; Paul M Glat; Lawrence A DiDomenico; Marissa J Carter; Charles M Zelen
Journal:  Int Wound J       Date:  2021-08-21       Impact factor: 3.099

Review 2.  Topical Biological Agents as Adjuncts to Improve Wound Healing in Chronic Diabetic Wounds: A Systematic Review of Clinical Evidence and Future Directions.

Authors:  Andrew Yew Wei Wong; Bernard Soon Yang Ong; Ainsley Ryan Yan Bin Lee; Aaron Shengting Mai; Sathiyamoorthy Selvarajan; Satish R Lakshminarasappa; Sook Muay Tay
Journal:  Cureus       Date:  2022-07-23

Review 3.  Human amniotic membrane products for patients with diabetic foot ulcers. do they help? a systematic review and meta-analysis.

Authors:  Yasmine Adel Mohammed; Hossam Khaled Farouk; Mohamed Ibrahim Gbreel; Abdelrahman Mahmoud Ali; Ali Ashraf Salah; Anas Zakarya Nourelden; Mohamed Mahmoud Abd-El Gawad
Journal:  J Foot Ankle Res       Date:  2022-09-14       Impact factor: 3.050

4.  Skin Substitutes for Adults With Diabetic Foot Ulcers and Venous Leg Ulcers: A Health Technology Assessment.

Authors: 
Journal:  Ont Health Technol Assess Ser       Date:  2021-06-04

5.  Contribution of amniotic membrane to the healing of iatrogenic vas deferens injury

Authors:  Sabri Demir; Ahmet Ertürk; Mehmet Zengin; Dinçer Yıldız; Siyami Karahan; Emrah Şenel
Journal:  Turk J Med Sci       Date:  2021-06-28       Impact factor: 0.973

6.  A prospective clinical trial evaluating changes in the wound microenvironment in patients with chronic venous leg ulcers treated with a hypothermically stored amniotic membrane.

Authors:  John P McQuilling; Marissa J Carter; Judith A Fulton; Keyur Patel; Bryan Doner; Thomas E Serena; Katie C Mowry
Journal:  Int Wound J       Date:  2021-05-06       Impact factor: 3.315
  6 in total

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