Abstract
IntroductionDiabetic foot ulcers (DFUs) are complex chronic wounds which have a major long-term impact on the morbidity, mortality and quality of patients. The objective of this study was to assess the efficacy and time sensitivity of human amnion/chorion membrane treatment in patients with chronic DFUs.MethodsThe Cochrane Library, PubMed, Embase and Web of Science databases were systematically searched to identify relevant articles up to 10 April 2017. All randomized controlled trials (RCTs) comparing human amnion/chorion membrane + standard therapy and standard therapy alone in patients with DFUs were included in the analysis. Eligible studies were reviewed and data extracted into standard form. The Cochrane Collaboration’s tool for assessing the risk of bias was used. Review manager version 5.3 software was used for statistical analysis. Data were analyzed using a random effect model.ResultsOverall, the initial search of the four databases identified 352 published studies; of these, seven RCTS were ultimately included in the meta-analysis. The overall test effect in the group assessed at 4 weeks was Z = 4.14 [P < 0.0001; odds ratio (OR) 0.05; 95% confidence interval (CI) 0.01–0.21]. The overall test effect in the group assessed at 6 weeks was Z = 4.28 (P < 0.0001; OR 0.07; 95% CI 0.02–0.23). The overall effect in the group assessed at 12 weeks was Z = 4.96 (P < 0.00001; OR 0.10; 95% CI 0.04–0.24. The results showed that patients receiving amniotic membrane + standard therapy had far fewer incomplete healing wounds than those receiving standard of care alone. Assessment of the wound healing state at 4 and 6 weeks revealed that the wound healing state was almost the same, but there was a net difference of wound healing state at 12 weeks.ConclusionHuman amnion/chorion membrane + standard of care treatment heals DFUs significantly faster than standard of care alone. When using the amnion in patients with DFUs, the optimal times to assess progress in wound healing should be 4 and 12 weeks.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-017-0298-8) contains supplementary material, which is available to authorized users.
Highlights
Diabetic foot ulcers (DFUs) are complex chronic wounds which have a major long-term impact on the morbidity, mortality and quality of patients
The results showed that patients receiving amniotic membrane ? standard therapy had far fewer incomplete healing wounds than those receiving standard of care alone
The delayed healing of ulcers increases the risk for severe wound infection and amputation [7, 8]; approximately half of all people undergoing non-traumatic amputations are diagnosed with diabetes [9], with studies showing that up to 88% of all diabetes-related amputations are preceded by a foot ulcer [10, 11]
Summary
Diabetic foot ulcers (DFUs) are complex chronic wounds which have a major long-term impact on the morbidity, mortality and quality of patients. When using the amnion in patients with DFUs, the optimal times to assess progress in wound healing should be 4 and 12 weeks. 25% of people with diabetes will develop a lower extremity ulcer over time [5, 6] The treatment of these wounds remains challenging as they are often slow to heal and frequently reoccur. The delayed healing of ulcers increases the risk for severe wound infection and amputation [7, 8]; approximately half of all people undergoing non-traumatic amputations are diagnosed with diabetes [9], with studies showing that up to 88% of all diabetes-related amputations are preceded by a foot ulcer [10, 11]. The main goal of treating DFUs is to promote a rapid and complete healing in order to reduce the risk of infection, amputation and other form of related complications
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