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Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective, randomised, multicentre study
Abstract
This 12‐week, prospective, randomised, controlled multi‐centre study compared the proportion of healed diabetic foot ulcers and mean healing time between patients receiving acellular matrix (AM) (study group) and standard of care (control group) therapies. Eighty‐six patients were randomised into study (47 patients) and control (39 patients) groups. No significant differences in demographics or pre‐treatment ulcer data were calculated. Complete healing and mean healing time were 69·6% and 5·7 weeks, respectively, for the study group and 46·2% and 6·8 weeks, respectively, for the control group. The proportion of healed ulcers between the groups was statistically significant ( P = 0·0289), with odds of healing in the study group 2·7 times higher than in the control group. Kaplan–Meier survivorship analysis for time to complete healing at 12 weeks showed a significantly higher non healing rate ( P = 0·015) for the control group (53·9%) compared with the study group (30·4%). After adjusting for ulcer size at presentation, which was a statistically significant covariate ( P = 0·0194), a statistically significant difference in non healing rate between groups was calculated ( P = 0·0233), with odds of healing 2·0 times higher in the study versus control group. This study supports the use of single‐application AM therapy as an effective treatment of diabetic, neuropathic ulcers.
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“Time to heal was reported in all studies, but only 4 studies [7,8,29,30]were eligible for metaanalysis.”
From Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis (2017) · cites this paper as [8]
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“Several published articles have evaluated in clinical trials and demonstrated its success in accelerating the healing rate [7,8,17].”
From Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis (2017) · cites this paper as [8]
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“Five studies [7,8,17,28,29] reported the number of complete wound healing in 12 weeks”
From Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis (2017) · cites this paper as [8]
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Cited by
A clinical trial of Integra Template for diabetic foot ulcer treatment
Driver, V. R., Lavery, L. A., Reyzelman, A. M., Dutra, T. G., Dove, C. R., Kotsis, S. V., Kim, H. M., & Chung, K. C. (2015) · Wound Repair and Regeneration · doi:10.1111/wrr.12357 · Cited by 291
Self-citationChen, P., Vilorio, N. C., Dhatariya, K., Jeffcoate, W., Lobmann, R., McIntosh, C., Piaggesi, A., Steinberg, J., Vas, P., Viswanathan, V., et al. (2024) · Diabetes/Metabolism Research and Reviews · doi:10.1002/dmrr.3644 · Cited by 246
Publicly reported wound healing rates: the fantasy and the reality.
Fife, C. E., Eckert, K. A., & Carter, M. J. (2018) · Advances in Wound Care · doi:10.1089/wound.2017.0743 · Cited by 132
Guo, X., Mu, D., & Gao, F. (2017) · International Journal of Surgery · doi:10.1016/j.ijsu.2017.02.008 · Cited by 80
Cazzell, S., Vayser, D., Pham, H., Walters, J., Reyzelman, A., Samsell, B., Dorsch, K., & Moore, M. (2017) · Wound Repair and Regeneration · doi:10.1111/wrr.12551 · Cited by 78
Self-citationMohammed, Y. A., Farouk, H. K., Gbreel, M. I., Ali, A. M., Salah, A. A., Nourelden, A. Z., & Gawad, M. M. A. (2022) · Journal of Foot and Ankle Research · doi:10.1186/s13047-022-00575-y · Cited by 36
Sui, L., Xie, Q., Jiang, H.-T., & Li, X.-D. (2024) · BMC Endocrine Disorders · doi:10.1186/s12902-024-01550-3 · Cited by 14
Metadata
- Authors
- Reyzelman, A., Crews, R. T., Moore, J. C., Moore, L., Mukker, J. S., Offutt, S., Tallis, A., Turner, W. B., Vayser, D., Winters, C., & Armstrong, D. G.
- Venue
- International Wound Journal
- Publisher
- Wiley
- Published
- 2009-06
- Volume
- 6
- Issue
- 3
- Pages
- 196-208
- ISSN
- 1742-4801
- 1742-481X
- Cited by
- 169
- References
- 0
- Language
- en
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