The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index; none of the 38 sources its claims cite is checked for support yet.
A clinical trial of Integra Template for diabetic foot ulcer treatment
Open accessAbstract
Individuals with diabetes mellitus are at an increased risk of developing a diabetic foot ulcer (DFU). This study evaluated the safety and efficacy of Integra Dermal Regeneration Template (IDRT) for the treatment of nonhealing DFUs. The Foot Ulcer New Dermal Replacement Study was a multicenter, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption. Thirty‐two sites enrolled and randomized 307 subjects with at least one DFU. Consented patients were entered into the 14‐day run‐in phase where they were treated with the standard of care (0.9% sodium chloride gel) plus a secondary dressing and an offloading/protective device. Patients with less than 30% reepithelialization of the study ulcer after the run‐in phase were randomized into the treatment phase. The subjects were randomized to the control treatment group (0.9% sodium chloride gel; n = 153) or the active treatment group (IDRT, n = 154). The treatment phase was 16 weeks or until confirmation of complete wound closure (100% reepithelialization of the wound surface), whichever occurred first. Following the treatment phase, all subjects were followed for 12 weeks. Complete DFU closure during the treatment phase was significantly greater with IDRT treatment (51%) than control treatment (32%; p = 0.001) at sixteen weeks. The median time to complete DFU closure was 43 days for IDRT subjects and 78 days for control subjects in wounds that healed. The rate of wound size reduction was 7.2% per week for IDRT subjects vs. 4.8% per week for control subjects ( p = 0.012). For the treatment of chronic DFUs, IDRT treatment decreased the time to complete wound closure, increased the rate of wound closure, improved components of quality of life and had less adverse events compared with the standard of care treatment. IDRT could greatly enhance the treatment of nonhealing DFUs.
Overview
CoChat Summary
TL;DR
In the FOUNDER multicenter randomized trial, Integra Dermal Regeneration Template (IDRT) significantly increased complete closure of chronic diabetic foot ulcers compared with standard of care. IDRT also reduced time to closure and improved some quality-of-life measures, with fewer severe adverse events.
Key findings
- Complete DFU closure during the 16-week treatment phase was 51% (79/154) with IDRT vs 32% (49/153) with control (p = 0.001); by blinded computerized planimetry, closure was 50% vs 31% (p = 0.001).
- Median time to complete closure among healed wounds was 43 days for IDRT vs 78 days for control; wound size reduction was 7.2% per week vs 4.8% per week (p = 0.012).
- At 12 weeks, complete closure was 45% (70/154) with IDRT vs 20% (31/153) with control (p < 0.001), with an odds ratio of 3.3 (95% CI 2.0, 5.4).
- Severe adverse events occurred in 15.6% of IDRT subjects vs 26.8% of control subjects (p = 0.016); quality-of-life improvements were significant for Physical Functioning (p = 0.047) and Bodily Pain (p = 0.033).
Methods
- Multicenter, randomized, controlled, parallel-group trial under an Investigational Device Exemption at 32 sites; 307 subjects with nonhealing DFUs were randomized 1:1 to IDRT (n = 154) or control saline gel standard of care (n = 153) after a 14-day run-in in which only ulcers with less than 30% reepithelialization were randomized.
- Treatment phase lasted up to 16 weeks or until confirmed complete wound closure, followed by a 12-week follow-up; the primary endpoint was investigator-assessed complete closure during the treatment phase, with blinded central computerized planimetry as a secondary assessment.
- Efficacy analyses used the intent-to-treat cohort; primary outcome used logistic regression adjusted for baseline ulcer size strata, with secondary outcomes analyzed by Cox regression, linear mixed-effects models, and closed testing to maintain type I error at 0.05.
Limitations
- The paper states that the study was not double-blinded, a limitation it notes applies to this and other DFU studies involving cellular and/or tissue-based products; it reports that this bias was addressed by third-party blinded computerized planimetry.
- The paper states that strict inclusion/exclusion criteria could affect generalizability, though it argues this was minimized by enrolling from 32 academic and private practice sites across the United States.
- Evident from the text: the study was sponsored and funded by Integra LifeSciences Corporation, and multiple authors report grants, personal fees, or nonfinancial support from Integra, which is not framed by the authors as a limitation.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
0 Valid · 0 Not valid · 19 Not checked · 53 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
“Cell-based products also need multiple reapplications in treating a DFU whereas this study demonstrated that reapplications of IDRT are generally not necessary.”
§ A clinical trial of Integra Template for diabetic foot ulcer treatment > DISCUSSION
boosted- 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
“Complete DFU closure during the treatment phase was significantly greater with IDRT treatment (51%) than control treatment (32%; p 5 0.001) at sixteen weeks.”
- Also stated in: § Study subjects · plain
“Complete closure of the study ulcer during the treatment phase (16 weeks), as defined by the investigator, was significantly greater in the active group (51%; 79/154) in comparison to the control group (32%; 49/153, p 5 0.001).”
§ A clinical trial of Integra Template for diabetic foot ulcer treatment > Abstract
plainstates 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.
- Also stated in: § Study subjects · 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 median time to complete DFU closure was 43 days for IDRT subjects and 78 days for control subjects in wounds that healed.”
§ A clinical trial of Integra Template for diabetic foot ulcer treatment > Abstract
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
“The majority of AEs in both groups were mild.”
§ A clinical trial of Integra Template for diabetic foot ulcer treatment > Study subjects
plain- 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
“The rate of wound size reduction was 7.2% per week for IDRT subjects vs. 4.8% per week for control subjects (p 5 0.012).”
§ A clinical trial of Integra Template for diabetic foot ulcer treatment > Abstract
plainstates an association- 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.
42 more claims
Create a free account to see all 72 claims and every source verdict.
- Probably not a substantial claim. 13
- It may state two separate claims as one. 16
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“Although the final follow-up wound area was similar between two treatment groups, the percentage area reduction (PAR) was demonstrated to be significantly increased in several studies [23, 26, 27, 31, 34].”
From Effectiveness and safety of dermal matrix used for diabetic foot ulcer: a systematic review and meta-analysis of randomized controlled trials (2024) · cites this paper as [23]
Citations
Cites
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
Yannas, I. V., & Burke, J. F. (1980) · Journal of Biomedical Materials Research · doi:10.1002/jbm.820140314 · Cited by 889
Risk Factors for Foot Infections in Individuals With Diabetes
Lavery, L. A., Armstrong, D. G., Wunderlich, R. P., Mohler, M. J., Wendel, C. S., & Lipsky, B. A. (2006) · Diabetes Care · doi:10.2337/dc05-2425 · Cited by 787
Self-citationWieman, T. J., Smiell, J. M., & Su, Y. (1998) · Diabetes Care · doi:10.2337/diacare.21.5.822 · Cited by 683
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
The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers
Marston, W. A., Hanft, J., Norwood, P., Pollak, R., & for the Dermagraft Diabetic Foot Ulcer Study Group (2003) · Diabetes Care · doi:10.2337/diacare.26.6.1701 · Cited by 613
Steed, D. L., & the Diabetic Ulcer Study Group * (1995) · Journal of Vascular Surgery · doi:10.1016/s0741-5214(95)70245-8 · Cited by 610
Lower-Extremity Amputation in People With Diabetes: Epidemiology and Prevention
Bild, D. E., Selby, J. V., Sinnock, P., Browner, W. S., Braveman, P., & Showstack, J. A. (1989) · Diabetes Care · doi:10.2337/diacare.12.1.24 · Cited by 517
Research works printed but not linked: 3
- Boulton A, 2005, Diabetic foot and ulceration: epidemiology and pathophysiology
- Gibson D, 2009, MMPs made easy, Wound Int, 1, 1
- Gethin G, 2007, Wound measurement: the contribution to practice, EWMA J., 7, 26
Cited by
Chronic Wound Healing: A Review of Current Management and Treatments
Han, G., & Ceilley, R. (2017) · Advances in Therapy · doi:10.1007/s12325-017-0478-y · Cited by 2,096
Nanotechnology-Driven Therapeutic Interventions in Wound Healing: Potential Uses and Applications
Hamdan, S., Pastar, I., Drakulich, S., Dikici, E., Tomic‐Canic, M., Deo, S. K., & Daunert, S. (2017) · ACS Central Science · doi:10.1021/acscentsci.6b00371 · Cited by 549
Advanced bandages for diabetic wound healing
Matoori, S., Veves, A., & Mooney, D. J. (2021) · Science Translational Medicine · doi:10.1126/scitranslmed.abe4839 · Cited by 498
Amirrah, I. N., Lokanathan, Y., Zulkiflee, I., Wee, M. F. M. R., Motta, A., & Fauzi, M. B. (2022) · Biomedicines · doi:10.3390/biomedicines10092307 · Cited by 426
Recent advances in inorganic nanomaterials for wound-healing applications
Nethi, S. K., Das, S., Patra, C. R., & Mukherjee, S. (2019) · Biomaterials Science · doi:10.1039/c9bm00423h · Cited by 371
A strain-programmed patch for the healing of diabetic wounds
Theocharidis, G., Yuk, H., Roh, H., Wang, L., Mezghani, I., Wu, J., Kafanas, A., Contreras, M., Sumpio, B. J., Li, Z., et al. (2022) · Nature Biomedical Engineering · doi:10.1038/s41551-022-00905-2 · Cited by 370
Diagnosis and Management of Diabetic Foot Complications
Boulton, A. J. M., Armstrong, D. G., Krisner, R., Attinger, C. E., Lavery, L. A., Lipsky, B. A., Mills, J. L., & Steinberg, J. S. (2018) · ADA Clinical Compendia · doi:10.2337/db20182-1 · Cited by 301
Self-citationA natural biological adhesive from snail mucus for wound repair
Deng, T., Gao, D., Song, X., Zhou, Z., Zhou, L., Tao, M., Jiang, Z., Yang, L., Luo, L., Zhou, A., et al. (2023) · Nature Communications · doi:10.1038/s41467-023-35907-4 · Cited by 289
Recent Advances in Nanomaterial-Based Wound-Healing Therapeutics
Naskar, A., & Kim, K.-S. (2020) · Pharmaceutics · doi:10.3390/pharmaceutics12060499 · Cited by 254
Managing Diabetic Foot Ulcers: Pharmacotherapy for Wound Healing
Dixon, D., & Edmonds, M. (2021) · Drugs · doi:10.1007/s40265-020-01415-8 · Cited by 224
Chen, 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
Evaluation and Management of Lower-Extremity Ulcers
Singer, A. J., Tassiopoulos, A. K., & Kirsner, R. S. (2017) · New England Journal of Medicine · doi:10.1056/nejmra1615243 · Cited by 245
Instructive microenvironments in skin wound healing: Biomaterials as signal releasing platforms
Castaño, Ó., Pérez‐Amodio, S., Navarro‐Requena, C., Mateos‐Timoneda, M. A., & Engel, E. (2018) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2018.03.012 · Cited by 221
Rayman, G. A., Vas, P. R. J., Dhatariya, K., Driver, V. R., Hartemann, A., Löndahl, M., Piaggesi, A., Apelqvist, J., Attinger, C., Game, F. L., et al. (2020) · Diabetes/Metabolism Research and Reviews · doi:10.1002/dmrr.3283 · Cited by 221
Self-citationHealth economics of diabetic foot ulcer and recent trends to accelerate treatment
Jodheea-Jutton, A., Hindocha, S., & Bhaw‐Luximon, A. (2022) · The Foot · doi:10.1016/j.foot.2022.101909 · Cited by 221
Engineered Biopolymeric Scaffolds for Chronic Wound Healing
Dickinson, L. E., & Gerecht, S. (2016) · Frontiers in Physiology · doi:10.3389/fphys.2016.00341 · Cited by 201
Topical antimicrobial agents for treating foot ulcers in people with diabetes
Dumville, J. C., Lipsky, B. A., Hoey, C., Cruciani, M., Fiscon, M., & Xia, J. (2017) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011038.pub2 · Cited by 184
Patil, P., Russo, K. A., McCune, J. T., Pollins, A. C., Cottam, M. A., Dollinger, B. R., DeJulius, C. R., Gupta, M. K., d’Arcy, R., Colazo, J. M., et al. (2022) · Science Translational Medicine · doi:10.1126/scitranslmed.abm6586 · Cited by 146
Cheng, L., Zhuang, Z., Yin, M., Lü, Y., Liu, S., Zhan, M., Zhao, L., He, Z., Meng, F., Tian, S., et al. (2024) · Nature Communications · doi:10.1038/s41467-024-54075-7 · Cited by 141
The Basics of Integra Dermal Regeneration Template and its Expanding Clinical Applications
Chang, D. K., Louis, M. R., Gimenez, A. R., & Reece, E. M. (2019) · Seminars in Plastic Surgery · doi:10.1055/s-0039-1693401 · Cited by 139
Tissue Engineered Skin Substitutes
Goodarzi, P., Falahzadeh, K., Nematizadeh, M., Farazandeh, P., Payab, M., Larijani, B. A., Tayanloo-Beik, A., & Arjmand, B. (2018) · Advances in experimental medicine and biology · doi:10.1007/5584_2018_226 · Cited by 133
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
Xue, M., Zhao, R., Lin, H., & Jackson, C. (2018) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2018.03.002 · Cited by 125
Healing of Chronic Wounds: An Update of Recent Developments and Future Possibilities
Kathawala, M. H., Ng, W. L., Liu, D., Naing, M. W., Yeong, W. Y., Spiller, K. L., Dyke, M. E. V., & Ng, K. W. (2019) · Tissue Engineering Part B Reviews · doi:10.1089/ten.teb.2019.0019 · Cited by 120
Skin substitutes as treatment for chronic wounds: current and future directions
Vecin, N. M., & Kirsner, R. S. (2023) · Frontiers in Medicine · doi:10.3389/fmed.2023.1154567 · Cited by 105
Collagen Type I: A Versatile Biomaterial
Chowdhury, S. R., Busra, M. F. M., Lokanathan, Y., Ng, M. H., Law, J. X., Ude, C. C., & Idrus, R. B. H. (2018) · Advances in experimental medicine and biology · doi:10.1007/978-981-13-0947-2_21 · Cited by 102
do Amaral, R. J. F. C., Zayed, N., Paşcu, E. I., Cavanagh, B., Hobbs, C., Santarella, F., Simpson, C. R., Murphy, C. M., Sridharan, R., González‐Vázquez, A., et al. (2019) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2019.00371 · Cited by 102
Natural Polymer‐Based Materials for Wound Healing Applications
Ho, T. T., Tran, H. A., Doan, V. K., Maitz, J., Li, Z., Wise, S. G., Lim, K. S., & Rnjak‐Kovacina, J. (2024) · Advanced NanoBiomed Research · doi:10.1002/anbr.202300131 · Cited by 93
Vas, P. R. J., Rayman, G. A., Dhatariya, K., Driver, V. R., Hartemann, A., Löndahl, M., Piaggesi, A., Apelqvist, J., Attinger, C., & Game, F. L. (2020) · Diabetes/Metabolism Research and Reviews · doi:10.1002/dmrr.3284 · Cited by 90
Self-citationDiDomenico, L. A., Orgill, D. P., Galiano, R. D., Serena, T. E., Carter, M. J., Kaufman, J. P., Young, N. J., Jacobs, A. M., & Zelen, C. M. (2018) · International Wound Journal · doi:10.1111/iwj.12954 · Cited by 89
A Review of Cellular and Acellular Matrix Products: Indications, Techniques, and Outcomes
Hughes, O. B., Rakosi, A., MacQuhae, F., Herskovitz, I., Fox, J. D., & Kirsner, R. S. (2016) · Plastic & Reconstructive Surgery · doi:10.1097/prs.0000000000002643 · Cited by 88
Topical Application of a Mast Cell Stabilizer Improves Impaired Diabetic Wound Healing
Tellechea, A., Bai, S., Dangwal, S., Theocharidis, G., Nagai, M., Koerner, S. K., Cheong, J. E., Bhasin, S. S., Shih, T., Zheng, Y., et al. (2019) · Journal of Investigative Dermatology · doi:10.1016/j.jid.2019.08.449 · Cited by 86
Li, Y., Zhao, W., Chen, S., Zhai, H., & Wu, S. (2023) · Materials & Design · doi:10.1016/j.matdes.2023.112623 · Cited by 83
Current Status and Future of Skin Substitutes for Chronic Wound Healing
Nicholas, M. N., & Yeung, J. (2016) · Journal of Cutaneous Medicine and Surgery · doi:10.1177/1203475416664037 · Cited by 83
Xian, C., Zhang, Z., You, X., Fang, Y., & Wu, J. (2022) · Advanced Functional Materials · doi:10.1002/adfm.202202410 · Cited by 79
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-citationWu, S., Carter, M. J., Cole, W., Crombie, R. E., Kapp, D., Kim, P. J., Milne, C., Molnar, J. A., Niezgoda, J., Woo, K. Y., et al. (2023) · Journal of Wound Care · doi:10.12968/jowc.2023.32.sup4b.s1 · Cited by 78
Self-citationPiaggesi, A., Läuchli, S., Bassetto, F., Biedermann, T., Marques, A. P., Najafi, B., Palla, I., Scarpa, C., Seimetz, D., Triulzi, I., et al. (2018) · Journal of Wound Care · doi:10.12968/jowc.2018.27.sup6a.s1 · Cited by 76
Infectious Complications Associated with the Use of Integra: A Systematic Review of the Literature
Gonzalez, S. R., Wolter, K. G., & Yuen, J. C. (2020) · Plastic & Reconstructive Surgery Global Open · doi:10.1097/gox.0000000000002869 · Cited by 75
Ramezankhani, R., Torabi, S., Minaei, N., Madani, H., Rezaeiani, S., Hassani, S., Gee, A. P., Dominici, M., Silva, D. N., Baharvand, H., et al. (2020) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2020.547653 · Cited by 73
Engineering a photosynthetic bacteria-incorporated hydrogel for infected wound healing
Zhao, E., Liu, H., Jia, Y., Xiao, T., Li, J., Zhou, G., Wang, J., Zhou, X., Liang, X., Zhang, J., et al. (2021) · Acta Biomaterialia · doi:10.1016/j.actbio.2021.12.017 · Cited by 64
Extracellular matrix-inspired biomaterials for wound healing
Hosty, L., Heatherington, T., Quondamatteo, F., & Browne, S. (2024) · Molecular Biology Reports · doi:10.1007/s11033-024-09750-9 · Cited by 63
“For example, the ‘Integra Dermal Regeneration Template’ (IDRT), a bi-layered collagen/ chondroitin-6-sul - phate matrix, has shown significant promise to promote DFU healing [ 48 ].”
BackgroundResultInfluentialBioengineering Skin Substitutes for Wound Management—Perspectives and Challenges
Kondej, K., Zawrzykraj, M., Czerwiec, K., Deptuła, M., Tymińska, A., & Pikuła, M. (2024) · International Journal of Molecular Sciences · doi:10.3390/ijms25073702 · Cited by 62
Neurotensin-loaded PLGA/CNC composite nanofiber membranes accelerate diabetic wound healing
Zheng, Z., Liu, Y., Huang, W., Mo, Y., Lan, Y., Guo, R., & Cheng, B. (2018) · Artificial Cells Nanomedicine and Biotechnology · doi:10.1080/21691401.2018.1460372 · Cited by 62
Scaffold-based delivery of mesenchymal stromal cells to diabetic wounds
Du, S., Zeugolis, D. I., & O’Brien, T. (2022) · Stem Cell Research & Therapy · doi:10.1186/s13287-022-03115-4 · Cited by 61
Defining complete wound closure: Closing the gap in clinical trials and practice
Gould, L. J., & Li, W. W. (2019) · Wound Repair and Regeneration · doi:10.1111/wrr.12707 · Cited by 56
Yang, H., Fierro, F. A., So, M., Yoon, D. J., Nguyen, A. V., Gallegos, A., Bagood, M. D., Rojo-Castro, T., Alex, A., Stewart, H., et al. (2020) · Stem Cells Translational Medicine · doi:10.1002/sctm.19-0380 · Cited by 56
Awasthi, A., Gulati, M., Kumar, B., Kaur, J., Vishwas, S., Khursheed, R., Porwal, O., Alam, A., Ramanunny, A. K., Corrie, L., et al. (2022) · BioMed Research International · doi:10.1155/2022/1659338 · Cited by 55
McGrath, M., Zimkowska, K., Genoud, K. J., Maughan, J., Gonzalez, J. G., Browne, S., & O’Brien, F. J. (2023) · ACS Applied Materials & Interfaces · doi:10.1021/acsami.2c18837 · Cited by 53
Brockmann, I., Ehrenpfordt, J., Sturmheit, T., Brandenburger, M., Kruse, C., Zille, M., Rose, D., & Boltze, J. (2018) · Stem Cells International · doi:10.1155/2018/4623615 · Cited by 53
Updates on Recent Clinical Assessment of Commercial Chronic Wound Care Products
Sharma, A., Sharma, D., & Zhao, F. (2023) · Advanced Healthcare Materials · doi:10.1002/adhm.202300556 · Cited by 51
Çetinkalp, Ş., Gokce, E. H., Şimşir, I., Tanrıverdi, S. T., Doğan, F., Avcı, Ç. B., Eroğlu, İ., Utku, T., Gündüz, C., & Özer, Ö. (2020) · The International Journal of Lower Extremity Wounds · doi:10.1177/1534734620907773 · Cited by 51
Dean, J., Hoch, C. C., Wollenberg, B., Navidzadeh, J., Maheta, B. J., Mandava, A., Knoedler, S. A., Sherwani, K., Baecher, H., Schmitz, A. M., et al. (2025) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2024.1461328 · Cited by 49
Chávez, J. C. P., McGrath, M., O’Connor, C., Dervan, A. G., Dixon, J. E., Kearney, C. J., Browne, S., & O’Brien, F. J. (2025) · Biomaterials Science · doi:10.1039/d4bm01051e · Cited by 49
Advances in Addressing Full-Thickness Skin Defects: A Review of Dermal and Epidermal Substitutes
Lucich, E. A., Rendon, J. L., & Valerio, I. L. (2018) · Regenerative Medicine · doi:10.2217/rme-2017-0047 · Cited by 49
Identifying and treating foot ulcers in patients with diabetes: saving feet, legs and lives
Ousey, K. J., Chadwick, P., Jawień, A., Tariq, G., Nair, H. K. R., Lázaro‐Martínez, J. L., Sandy‐Hodgetts, K., Alves, P. J. P., Wu, S., & Moore, Z. E. H. (2018) · Journal of Wound Care · doi:10.12968/jowc.2018.27.sup5.s1 · Cited by 48
Recent Advancement of Functional Hydrogels toward Diabetic Wound Management
Ghosal, K., Chakraborty, D., Roychowdhury, V., Ghosh, S., & Dutta, S. (2022) · ACS Omega · doi:10.1021/acsomega.2c05538 · Cited by 48
Armstrong, D. G., Orgill, D. P., Galiano, R. D., Glat, P. M., DiDomenico, L. A., Carter, M. J., & Zelen, C. M. (2021) · International Wound Journal · doi:10.1111/iwj.13675 · Cited by 48
Chen, P., Campillo-Vilorio, N., Dhatariya, K., Jeffcoate, W. J., Lobmann, R., McIntosh, C. D., Piaggesi, A., Steinberg, J. S., VAS, P. R., Viswanathan, V., et al. (2024) · Diabetes/Metabolism Research and Reviews · doi:10.1002/dmrr.3786 · Cited by 47
Laiva, A. L., O’Brien, F. J., & Keogh, M. B. (2021) · Biomedicines · doi:10.3390/biomedicines9020160 · Cited by 47
Current Use of Biological Scaffolds in Plastic Surgery
Panayi, A. C., & Orgill, D. P. (2018) · Plastic & Reconstructive Surgery · doi:10.1097/prs.0000000000005102 · Cited by 44
Snyder, R., Galiano, R. D., Mayer, P. V., Rogers, L. C., Alvarez, O. M., & The Sanuwave Trial Investigators (2018) · Journal of Wound Care · doi:10.12968/jowc.2018.27.12.822 · Cited by 44
(2016) · PubMed Central
Self-citationLantis, J. C., Snyder, R., Reyzelman, A. M., Van Gils, C. C., Sigal, F., Vayser, D., Caporusso, J. M., Cazzell, S., Lavery, L. A., & PriMatrix Study Group (2021) · Journal of Wound Care · doi:10.12968/jowc.2021.30.sup7.s18 · Cited by 36
Self-citationAdvances and applications of biomimetic biomaterials for endogenous skin regeneration
Wang, M., Hong, Y., Fu, X., & Sun, X. (2024) · Bioactive Materials · doi:10.1016/j.bioactmat.2024.04.011 · Cited by 40
Lavery, L. A., Davis, K. E., Fontaine, J. L., Farrar, J. D., Bhavan, K., Öz, O. K., & Crisologo, P. A. (2020) · The American Journal of Surgery · doi:10.1016/j.amjsurg.2020.02.044 · Cited by 40
Self-citationWang, K. J., Wang, Y., Shi, W., Shen, K., Tao, K., Ling, R., Huang, Y., Fu, X., & Hu, D. (2024) · Diabetes/Metabolism Research and Reviews · doi:10.1002/dmrr.3776 · Cited by 38
Jiang, S., Li, S. C., Huang, C., Chan, B. P., & Du, Y. (2018) · Advanced Healthcare Materials · doi:10.1002/adhm.201700894 · Cited by 37
Nanomaterials-based Drug Delivery Approaches for Wound Healing
Girija, A. R., Balasubramanian, S., & Cowin, A. J. (2022) · Current Pharmaceutical Design · doi:10.2174/1381612828666220328121211 · Cited by 37
Clinical Application of Bioresorbable, Synthetic, Electrospun Matrix in Wound Healing
MacEwan, M. R., Jeng, L., Kovacs, T. R., & Sallade, E. (2022) · Bioengineering · doi:10.3390/bioengineering10010009 · Cited by 37
Mohammed, 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
Yang, F., Mo, D., Wu, B., Chen, J., Liu, Q., Chen, W., Pang, J., Wang, W., Jing, X., Xiong, Y., et al. (2024) · Journal of Controlled Release · doi:10.1016/j.jconrel.2024.11.047 · Cited by 36
Ahmad, T., McGrath, S., Sirafim, C., do Amaral, R. J. F. C., Soong, S.-L., Sitram, R., Turkistani, S., Santarella, F., & Kearney, C. J. (2020) · Biomaterials Science · doi:10.1039/d0bm01277g · Cited by 36
Yan, L., Castaño, I. M., Sridharan, R., Kelly, D. C., Lemoine, M., Cavanagh, B., Dunne, N., McCarthy, H. O., & O’Brien, F. J. (2020) · Materials Science and Engineering C · doi:10.1016/j.msec.2020.111022 · Cited by 35
Shu, H., Xia, Z., Qin, X., Wang, X., Lu, W., Luo, Q., Zhang, Z., & Xiong, X. (2022) · Frontiers in Surgery · doi:10.3389/fsurg.2022.978407 · Cited by 33
Marinkovic, M., Sridharan, R., Santarella, F., Smith, A., Garlick, J. A., & Kearney, C. J. (2021) · Journal of Biomedical Materials Research Part A · doi:10.1002/jbm.a.37173 · Cited by 33
Metal nanoparticles and biomaterials: The multipronged approach for potential diabetic wound therapy
Azlan, A. Y. H. N., Katas, H., Busra, M. F. M., Salleh, N. A. M., & Smandri, A. (2021) · Nanotechnology Reviews · doi:10.1515/ntrev-2021-0046 · Cited by 33
Kurkipuro, J., Mierau, I., Wirth, T., Samaranayake, H. D., Smith, W., Kärkkäinen, H.-R., Tikkanen, M., & Yrjänheikki, J. (2022) · PLoS ONE · doi:10.1371/journal.pone.0264775 · Cited by 33
Fadilah, N. I. M., Maarof, M., Motta, A., Tabata, Y., & Fauzi, M. B. (2022) · Biomedicines · doi:10.3390/biomedicines10092226 · Cited by 33
Gordon, A. J., Alfonso, A. R., Nicholson, J., & Chiu, E. S. (2019) · Annals of Plastic Surgery · doi:10.1097/sap.0000000000002096 · Cited by 32
Ouyang, H., Yang, J., Wan, H., Huang, J., & Yin, Y. (2024) · Frontiers in Endocrinology · doi:10.3389/fendo.2024.1452192 · Cited by 31
Chen, A., Huang, W., Wu, L. L., An, Y., Xuan, T., He, H., Ye, M., Qi, L., & Wu, J. (2020) · ACS Applied Bio Materials · doi:10.1021/acsabm.0c00096 · Cited by 31
Montanaro, M., Meloni, M., Anemona, L., Giurato, L., Scimeca, M., Izzo, V., Servadei, F., Smirnov, A., Candi, E., Mauriello, A., et al. (2020) · The International Journal of Lower Extremity Wounds · doi:10.1177/1534734620945559 · Cited by 31
Jiang, L., Dong, J., Jiang, M., Tan, W., Zeng, Y., Liu, X., Wang, P., Jiang, H., Zhou, J., Liu, X., et al. (2025) · Biomaterials · doi:10.1016/j.biomaterials.2025.123196 · Cited by 30
Porel, P., Kaur, M., Sharma, V., & Aran, K. R. (2025) · Journal of Diabetes & Metabolic Disorders · doi:10.1007/s40200-025-01588-7 · Cited by 30
Biological Mechanisms of Chronic Wound and Diabetic Foot Healing: The Role of Collagen
Stupin, V. A., Gabitov, R., Sinelnikova, T. G., & Silina, E. V. (2018) · Serbian Journal of Experimental and Clinical Research · doi:10.2478/sjecr-2018-0077 · Cited by 30
Panayi, A. C., Haug, V., Liu, Q., Wu, M., Karvar, M., Aoki, S., Ma, C., Hamaguchi, R., Endo, Y., & Orgill, D. P. (2020) · Biomedical Materials · doi:10.1088/1748-605x/abc3dc · Cited by 30
Review of History of Basic Principles of Burn Wound Management
Kim, H., Shin, S., & Han, D. (2022) · Medicina · doi:10.3390/medicina58030400 · Cited by 29
Self-citationHicks, C. W., Zhang, G. Q., Canner, J. K., Mathioudakis, N. N., Coon, D., Sherman, R. L., & Abularrage, C. J. (2020) · Plastic & Reconstructive Surgery · doi:10.1097/prs.0000000000007166 · Cited by 29
Campitiello, F., Mancone, M., Cammarota, M., D’Agostino, A., Ricci, G., Stellavato, A., Corte, A. D., Pirozzi, A. V. A., Scialla, G., Schiraldi, C., et al. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22137085 · Cited by 28
Skin movement, wound repair and development of engineered skin
Herskovitz, I., MacQuhae, F., Fox, J. D., & Kirsner, R. S. (2015) · Experimental Dermatology · doi:10.1111/exd.12916 · Cited by 27
Chen, A. C.-Y., Lu, Y., Hsieh, C., Chen, Y., Chang, K.-C., & Chang, D. (2023) · Advances in Wound Care · doi:10.1089/wound.2023.0024 · Cited by 27
The Role of Dermal Matrices in Treating Inflammatory and Diabetic Wounds
Climov, M., Bayer, L. R., Moscoso, A. V., Matsumine, H., & Orgill, D. P. (2016) · Plastic & Reconstructive Surgery · doi:10.1097/prs.0000000000002652 · Cited by 24
Monami, M., Scatena, A., Ragghianti, B., Miranda, C., Monge, L., Silverii, G. A., Uccioli, L., Vermigli, C., Syndrome, F. T. P. O. T. I. G. F. T. T. O. D. F., Bernetti, A., et al. (2024) · Acta Diabetologica · doi:10.1007/s00592-024-02426-7 · Cited by 26
Valsami, E., Chu, G., Guan, M., Gilman, J., Theocharidis, G., & Veves, A. (2025) · Advances in Therapy · doi:10.1007/s12325-025-03212-9 · Cited by 25
Advances in Dermoepidermal Skin Substitutes for Diabetic Foot Ulcers
Álvaro‐Afonso, F. J., García‐Álvarez, Y., Lázaro‐Martínez, J. L., Kakagia, D. D., & Παπάνας, Ν. (2019) · Current Vascular Pharmacology · doi:10.2174/1570161117666190408170144 · Cited by 25
Collagen-Based Products in Wound, Skin, and Health Care
Sen, C. K., Friday, A. J., Khanna, S., & Roy, S. (2025) · Advances in Wound Care · doi:10.1177/21621918251361118 · Cited by 24
Galiano, R. D., Snyder, R., Mayer, P. V., Rogers, L. C., Alvarez, O. M., & The Sanuwave Trial Investigators (2019) · Journal of Wound Care · doi:10.12968/jowc.2019.28.6.383 · Cited by 23
Gupta, S. C., Moiemen, N. S., Fischer, J. P., Attinger, C. E., Jeschke, M. G., Taupin, P., & Orgill, D. P. (2024) · Plastic & Reconstructive Surgery Global Open · doi:10.1097/gox.0000000000005674 · Cited by 23
Clinic visit frequency in wound care matters: data from the US wound registry
Carter, M. J., & Fife, C. E. (2017) · Journal of Wound Care · doi:10.12968/jowc.2017.26.sup1.s4 · Cited by 23
Metadata
- Authors
- Driver, V. R., Lavery, L. A., Reyzelman, A. M., Dutra, T. G., Dove, C. R., Kotsis, S. V., Kim, H. M., & Chung, K. C.
- Affiliations
- Brown University (US)
- The University of Texas Southwestern Medical Center (US)
- University of California, San Francisco (US)
- Samuel Merritt University (US)
- Advanced Foot & Ankle Center Las Vegas Nevada
- University of Michigan (US)
- Corresponding author
- Driver, Vickie R.
- Venue
- Wound Repair and Regeneration
- Publisher
- Wiley
- Published
- 2015-10-19
- Volume
- 23
- Issue
- 6
- Pages
- 891-900
- ISSN
- 1067-1927 (ISSN-L)
- 1524-475X
- OpenAlex
- W2159363192
- Semantic Scholar
- d7c51f0598a489f6edfd9a38e932c572e1097785
- Cited by
- 291
- References
- 33
- Citations by year
- 2026: 21 · 2025: 24 · 2024: 39 · 2023: 31 · 2022: 31 · 2021: 15 · 2020: 30 · 2019: 20 · 2018: 31 · 2017: 40 · 2016: 7 · 2015: 1
- FWCI
- 17.38
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Wound Repair and Regeneration (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Integra LifeSciences Corporation
- 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, Integra dermal regeneration template, skin substitutes, wound healing, re-epithelialization, wound closure, diabetes mellitus, quality of life, adverse events
- MeSH terms
- Chondroitin Sulfates, Collagen, Follow-Up Studies, Humans, Middle Aged, Quality of Life, Regeneration, United States, Wound Healing, Treatment Outcome, Practice Guidelines as Topic, Diabetic Foot, Re-Epithelialization
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-11-13, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-11-13 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
