Human placental membrane as a wound cover for chronic diabetic foot ulcers: a prospective, postmarket, CLOSURE study
| Autor: | Maria A Kasper, Brian D O'Carroll, Alexander M. Reyzelman, Joel M Neutel, Gabriel J Halperin, Shawn Cazzell, Douglas J Pacaccio |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Male
medicine.medical_specialty Time Factors Nursing (miscellaneous) Placenta 030209 endocrinology & metabolism Successful completion Risk Assessment Cohort Studies 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Pregnancy Diabetes mellitus medicine Clinical endpoint Humans In patient Prospective Studies Aged Postoperative Care Wound Healing Wound Closure Techniques business.industry Middle Aged Allografts medicine.disease Diabetic foot Diabetic Foot Surgery Treatment Outcome Diabetic foot ulcer Diabetes Mellitus Type 2 Female Fundamentals and skills Wound closure business Delayed healing Follow-Up Studies |
| Zdroj: | Journal of Wound Care. 27:S28-S37 |
| ISSN: | 2052-2916 0969-0700 |
| DOI: | 10.12968/jowc.2018.27.sup7.s28 |
| Popis: | Objective: To evaluate the safety and efficacy of a chorioamniotic allograft, used as a wound cover for chronic foot ulcers, in patients with diabetes. Methods: A multicentre, prospective, postmarket study where eligible patients received up to 11 weekly wound cover applications. Computerised planimetry was used to calculate the diabetic foot ulcer (DFU) area each week. The primary endpoint of the study was wound closure assessment. Secondary endpoints included DFU recurrence and morbidity. Results: A total of 63 patients with 64 ulcers were enrolled, after successful completion of a two-week run-in period. Patients were predominantly male and had risk factors for delayed healing. Mean baseline DFU area was 3.8cm2 (standard deviation (SD): 4.8). After 12 weeks, a total of 19 (40%) DFUs had closed. Results varied by size category, ‘small’ (≤2.0cm2), ‘medium’ (>2.0–4.0 cm2), and ‘large’ (>4.0–25.0 cm2), with higher percentage closure in the ‘small’ DFU group, compared with the ‘medium’ and ‘large’ DFUs (57%, 33%, and 10%, respectively). Of those DFUs that closed, the average closure time was 6.5 weeks. There were no unanticipated adverse events. Conclusion: Known risk factors for healing, including DFU size, location and duration, affected the outcomes. However, the results are in line with the literature and support the use of the chorioamniotic allograft in chronic and complex cases. |
| Databáze: | OpenAIRE |
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