A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers-Reference-Cited by-同舟云学术

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

Published:2020-01 Issue:1 Volume:9 Page:23-34
ISSN:2042-6305
Container-title:Journal of Comparative Effectiveness Research
language:en
Short-container-title:Journal of Comparative Effectiveness Research

Author:

Serena Thomas E¹,Yaakov Raphael¹,Moore Sarah¹,Cole Windy²,Coe Stacey²,Snyder Rob³,Patel Keyur⁴,Doner Bryan⁴,Kasper Maria A⁵,Hamil Rachel¹,Wendling Santina⁶,Sabolinski Michael L⁷^ORCID

Affiliation:

1. SerenaGroup® Research Foundation, Cambridge, MA 02140, USA

2. Kent State University College of Podiatric Medicine, Independence, OH 44131, USA

3. Barry University School of Podiatry Medicine, North Miami Beach, FL 33168, USA

4. D & P Medical Group, Pittsburgh, PA 15237, USA

5. Martin Foot & Ankle, York, PA 17402, USA

6. Organogenenis, Inc, Canton, MA 02021, USA

7. Sabolinski LLC, Franklin, MA 02038, USA

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.

Publisher

Future Medicine Ltd

Subject

Health Policy

Link

https://www.futuremedicine.com/doi/pdf/10.2217/cer-2019-0142

Reference47 articles.

1. Economic Costs of Diabetes in the U.S. in 2012

2. Preventing Foot Ulcers in Patients With Diabetes

3. Percent Change in Wound Area of Diabetic Foot Ulcers Over a 4-Week Period Is a Robust Predictor of Complete Healing in a 12-Week Prospective Trial

4. Surrogate End Points for the Treatment of Diabetic Neuropathic Foot Ulcers

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