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Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis
Open accessAbstract
BACKGROUND: Diabetic foot ulcer(DFU) is a chronic, refractory disease in need of multidisciplinary endeavour, miscellaneous strategies have been adopted to address this annoying issue, including acellular dermal matrix(ADM)/negative pressure wound therapy/standard of care (SOC) etc. However, consensus has not been reached. As a promising procedure, the efficacy and safety of ADM remains controversial. We therefore performed a meta-analysis of randomized controlled trials (RCTs) to compare the efficacy and safety of acellular dermal matrix to standard of care in DFU. METHODS: Databases, including Pubmed, Medline, Embase and Cochrane library were searched to identify RCTs comparing ADM to SOC in DFU patients. The outcomes mainly included complete wound healing, mean time to heal and adverse events. RESULTS: A total of 632 DFU patients from 6 RCTs were subjected to meta-analysis. The results showed that compared with the merely SOC, the complete healing rate in ADM group was higher both at 12 weeks [risk ratio (RR) 2.31, 95% confidence interval (CI) 1.42 to 3.76] and 16 weeks [RR 1.57, 95% CI 1.28 to 1.93]. The mean time to complete wound healing was shorter in ADM group [MD = -2.98, 95% CI: -5.15 to -0.82]. The occurrence of adverse event in both groups showed no significant difference [RR 0.98, 95%CI 0.58 to 1.67]. CONCLUSION: Compared with standard of care, acellular dermal matrix may accelerate the healing velocity of uninfected, non-ischemic, full-thickness diabetic foot ulcer. Acellular dermal matrix showed superiority compared with standard of care alone, while generating no more complications.
Overview
CoChat Summary
TL;DR
Acellular dermal matrix (ADM) plus standard of care (SOC) may accelerate healing of uninfected, non-ischemic, full-thickness diabetic foot ulcers compared with SOC alone, without increasing complications. The meta-analysis of 6 RCTs (632 patients) found higher complete healing rates at 12 and 16 weeks and shorter time to heal, but evidence was limited by product variation, publication bias, and short follow-up.
Key findings
- Complete wound healing at 12 weeks was higher with ADM than SOC: RR 2.31 (95% CI 1.42–3.76), with moderate heterogeneity (I² = 68%, P = 0.01); excluding the 4-week study gave RR 1.94 (95% CI 1.26–2.98).
- Complete wound healing at 16 weeks also favored ADM: RR 1.57 (95% CI 1.28–1.93), with limited heterogeneity (I² = 37%, P = 0.21).
- Time to heal favored ADM in the results section: MD −2.98 (95% CI −5.15 to −0.82, P = 0.007); after removing Zelen’s study, MD −2.04 (95% CI −3.78 to −0.29, P = 0.02). The discussion separately reports MD −2.56 (95% CI −3.55 to −1.57, P < 0.001).
- Adverse events did not differ significantly between ADM and SOC: RR 0.98 (95% CI 0.58–1.67), with limited heterogeneity (I² = 0%, P = 0.91).
Methods
- Systematic review and meta-analysis of RCTs comparing ADM plus SOC with SOC alone in diabetic foot ulcers; searches of PubMed, Medline, Embase, and Cochrane Library up to August 2016, limited to English-language articles.
- Included 6 RCTs involving 632 patients (330 ADM, 302 SOC); studies published 2004–2015, sample sizes 14–154, follow-up 4–16 weeks.
- Data extracted in duplicate; continuous outcomes pooled as mean difference (MD) and dichotomous outcomes as risk ratio (RR) with 95% CI using RevMan 5.3; heterogeneity assessed with I², with fixed- or random-effects models as appropriate; sensitivity analysis by omitting one study at a time.
Limitations
- The paper states: publication bias was likely because most studies were related to commercial corporations; there was no uniform ADM product; one study allowed a second ADM application; sample sizes were relatively small; data were insufficient for total analysis; follow-up was limited to 16 weeks with no long-term outcomes or recurrence data; and cost-efficiency was not assessed.
- The paper also notes moderate strength of evidence, limited blinding (only two studies reported assessor blinding), and only one study described allocation concealment.
- Evident from the text: the 12-week healing analysis had moderate heterogeneity (I² = 68%), and the time-to-heal analysis was sensitive to removal of one study (I² changed from 77% to 50%), indicating variability across included trials.
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Claims the paper makes
0 Valid · 0 Not valid · 29 Not checked · 44 Own results and interpretations
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“after deleting this study, the pooled outcome didn't change too much [MD ¼ À2.04, 95% CI: À3.78 to À0.29, P ¼ 0.02].”
§ Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis > 4.2. Time to heal
plainstates a cause- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“As to the 16 weeks investigation after treatment consisting of 217 DFUs, there still displayed a conspicuous superiority compared to the SOC group [RR 1.57, 95% CI 1.28 to 1.93; Fig. 4].”
§ Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis > 4.1. Complete wound healing
boostedstates a cause- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“There was, however, moderate heterogeneity between studies (I 2 ¼ 68%, P ¼ 0.01), thus, random effects model was used.”
§ Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis > 4.1. Complete wound healing
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“There were no significant differences in adverse events between ADM and SOC group during the follow-up ranged from 4 to 16 weeks [RR 0.98, 95% CI 0.58 to 1.67; Fig. 6].”
- Also stated in: § 6. Discussion · plain
“ADM showed superior advantages to conventional treatment, standard of care, meanwhile, generated no more complications [RR 0.98, 95% CI 0.58 to 1.67].”
§ Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis > 4.3. Adverse events
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Also stated in: § 6. Discussion · plain
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The pooled outcome by using random-effects model yielded an obvious effect in favor of the ADM group [MD ¼ À2.98, 95% CI: À5.15 to À0.82, P ¼ 0.007; Fig. 5].”
§ Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis > 4.2. Time to heal
boostedstates a cause- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
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Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Rated major: it would touch a result — a value a result rests on, reported and recomputed p-values on opposite sides of the significance level, two passages that conflict with no sign which is right, or a cited work retracted before this paper was published.
In the paper
§ Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis > 6. Discussion
“Additionally, the "time to heal" is reduced by using ADM [MD ¼ À2.56, 95% CI: À3.55 to À1.57, P < 0.001].”
§ Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis > 4.2. Time to heal
“The pooled outcome by using random-effects model yielded an obvious effect in favor of the ADM group [MD ¼ À2.98, 95% CI: À5.15 to À0.82, P ¼ 0.007; Fig. 5].”
Citations
Cites
Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA statement
Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., & for the PRISMA Group (2009) · BMJ · doi:10.1136/bmj.b2535 · Cited by 83,823
Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement
Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., & The PRISMA Group (2009) · PLoS Medicine · doi:10.1371/journal.pmed.1000097 · Cited by 64,042
Preferred reporting items for systematic reviews and meta-analyses: the PRISMA Statement.
(2009) · PubMed Central · Cited by 44,859
Global estimates of diabetes prevalence for 2013 and projections for 2035
Guariguata, L., Whiting, D. R., Hambleton, I., Beagley, J., Linnenkamp, U., & Shaw, J. E. (2014) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2013.11.002 · Cited by 4,642
Preventing Foot Ulcers in Patients With Diabetes
Singh, N. K. (2005) · JAMA · doi:10.1001/jama.293.2.217 · Cited by 3,152
Incidence, outcomes, and cost of foot ulcers in patients with diabetes.
Ramsey, S. D., Newton, K. M., Blough, D. K., McCulloch, D. K., Sandhu, N., Reiber, G. E., & Wagner, E. H. (1999) · Diabetes Care · doi:10.2337/diacare.22.3.382 · Cited by 1,064
Design of an artificial skin. I. Basic design principles
Yannas, I. V., & Burke, J. F. (1980) · Journal of Biomedical Materials Research · doi:10.1002/jbm.820140108 · Cited by 1,044
Design of an artificial skin. I. Basic design principles
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Veves, A., Falanga, V., Armstrong, D. G., Sabolinski, M. L., & Study, T. A. D. F. U. (2001) · Diabetes Care · doi:10.2337/diacare.24.2.290 · Cited by 643
Burden of Diabetic Foot Ulcers for Medicare and Private Insurers
Rice, J. B., Desai, U., Cummings, A. K. G., Birnbaum, H. G., Skornicki, M., & Parsons, N. B. (2014) · Diabetes Care · doi:10.2337/dc13-2176 · Cited by 624
Research works printed but not linked: 4
- Driver, 2015, vol. 23(6), 891
- SA, 2006, The use an acellular dermal regenerative tissue matrix in the treatment of lower extremity wounds: a prospective 16-week pilot study, Int. Wound J., 181
- Brigido, 2004, Effective management of major lower extremity wounds using an acellular regenerative tissue matrix: a pilot study, Orthopedics, 27, s145, 10.3928/0147-7447-20040102-14 · DOI · Paper page
- Schultz, 2011, vol. 19(2), 134
Cited by
Update on management of diabetic foot ulcers
Everett, E., & Mathioudakis, N. (2018) · Annals of the New York Academy of Sciences · doi:10.1111/nyas.13569 · Cited by 913
Conductive Biomaterials as Bioactive Wound Dressing for Wound Healing and Skin Tissue Engineering
Yu, R., Zhang, H., & Guo, B. (2021) · Nano-Micro Letters · doi:10.1007/s40820-021-00751-y · Cited by 928
Chronic Diabetic Wounds and Their Treatment with Skin Substitutes
Holl, J., Kowaléwski, C., Zimek, Z., Fiedor, P. S., Kamiński, A., Ołdak, T., Moniuszko, M., & Eljaszewicz, A. (2021) · Cells · doi:10.3390/cells10030655 · Cited by 382
Consensus on the application of negative pressure wound therapy of diabetic foot wounds
Ji, S., Liu, X., Huang, J., Bao, J., Chen, Z., Han, C., Hao, D., Hong, J., Hu, D., Jiang, Y., et al. (2021) · Burns & Trauma · doi:10.1093/burnst/tkab018 · Cited by 103
Wang, P., Wang, Y., Yang, Y., Gong, Y., Ji, H., Gan, Y., Xie, F., Fan, J., & Wang, X. (2022) · Journal of Nanobiotechnology · doi:10.1186/s12951-022-01468-9 · Cited by 82
Metadata
- Authors
- Guo, X., Mu, D., & Gao, F.
- Affiliations
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- China-Japan Friendship Hospital (CN)
- Corresponding author
- Mu, Dali
- Venue
- International Journal of Surgery
- Published
- 2017-04
- Volume
- 40
- Pages
- 1-7
- ISSN
- 1743-9159 (ISSN-L)
- 1743-9191
- OpenAlex
- W2588173601
- Cited by
- 80
- References
- 38
- Citations by year
- 2026: 6 · 2025: 9 · 2024: 14 · 2023: 17 · 2022: 8 · 2021: 10 · 2020: 10 · 2019: 3 · 2018: 3
- FWCI
- 0.53
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- www.elsevier.com/open-access/userlicense/1.0/ (vor, 730 d)
- Locations
- International Journal of Surgery (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetic Foot Ulcer Assessment and Management
- Health Sciences › Medicine › Surgery › Wound Healing and Treatments
- Health Sciences › Medicine › Surgery › Tissue Engineering and Regenerative Medicine
- Keywords
- diabetic foot ulcer, acellular dermal matrix, wound healing, negative pressure wound therapy, standard of care, adverse events, full-thickness wounds, treatment efficacy
- MeSH terms
- Aged, Female, Humans, Male, Middle Aged, Time Factors, Wound Healing, Randomized Controlled Trials as Topic, Treatment Outcome, Diabetic Foot, Negative-Pressure Wound Therapy, Standard of Care, Acellular Dermis
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- CoChat. (2026). Citation check: Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis. https://app.cochat.ai/papers/10.1016/j.ijsu.2017.02.008
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- Guo, X., Mu, D., & Gao, F. (2017). Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis. International Journal of Surgery. https://doi.org/10.1016/j.ijsu.2017.02.008
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