The DOI matches its Crossref record, with a small difference in title or year.
The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers
Abstract
OBJECTIVE—To determine if a human fibroblast–derived dermal substitute could promote the healing of diabetic foot ulcers. RESEARCH DESIGN AND METHODS—A randomized, controlled, multicenter study was undertaken at 35 centers throughout the U.S. and enrolled 314 patients to evaluate complete wound closure by 12 weeks. Patients were randomized to either the Dermagraft treatment group or control (conventional therapy). Except for the application of Dermagraft, treatment of study ulcers was identical for patients in both groups. All patients received pressure-reducing footwear and were allowed to be ambulatory during the study. RESULTS—The results demonstrated that patients with chronic diabetic foot ulcers of >6 weeks duration experienced a significant clinical benefit when treated with Dermagraft versus patients treated with conventional therapy alone. With regard to complete wound closure by week 12, 30.0% (39 of 130) of Dermagraft patients healed compared with 18.3% (21 of 115) of control patients (P = 0.023). The overall incidence of adverse events was similar for both the Dermagraft and control groups, but the Dermagraft group experienced significantly fewer ulcer-related adverse events. CONCLUSIONS—The data from this study show that Dermagraft is a safe and effective treatment for chronic diabetic foot ulcers.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
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
“As to clinical application, mostly ADM is used 1 or 2 times, while cellular skin substitute is reported to be 4 to 8 times due to short shelf-life, death of live cell [31,36,40].”
From Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis (2017) · cites this paper as [40]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
No references could be resolved yet.
Research works printed but not linked: 16
- Sanders LJ: Diabetes mellitus: prevention of amputation. J Am Podiatric Assoc 84:322–328, 1994 · DOI
- Levin M: Prevention and treatment of diabetic foot ulcers. J Wound Ostomy Continence Nurs 21:129–146, 1998 · DOI
- Bloomgarden ZT: American Diabetes Association 60th Scientific Sessions, 2002: the diabetic foot. Diabetes Care 24:946–951, 2001 · DOI
- Ollendorf D, Kotsanos J, Wishner W: Potential economic benefits of lower-extremity amputation prevention strategies in diabetes. Diabetes Care 21:1240–1245, 1998 · DOI
- Loots MA, Lamme EN, Mekkes J, Middlekoop E: Differences in cellular infiltrate and extracellular matrix of chronic diabetic and venous ulcers versus acute wounds. J Invest Dermatol 111:850–857, 1998 · DOI · Paper page
- Lazarus G, Cooper DM, Knighton DR, Margolis DJ, Pecoraro RE, Rodeheaver G, Robson MC: Definitions and guidelines for assessment of wounds and evaluation of healing. Arch Dermatol 130:489–493, 1994 · DOI
- Hehenberger K, Heilborn K, Brismar K, Hansson A: Inhibited proliferation of fibroblasts derived from chronic diabetic wounds and normal dermal fibroblasts treated with high glucose is associated with increased formation of L-lactate. Wound Rep Regen 6:135–141, 1998 · DOI
- Falanga VF, Grinnel B, Gilchrist Y, Maddox T, Moshelle A: Experimental approaches to chronic wounds. Wound Rep Reg 3:132–140, 1995 · DOI
- Naughton G, Mansbridge J, Gentzkow G: A metabolically active human dermal replacement for the treatment of diabetic foot ulcers. Artificial Organs 21:1203–1210, 1997 · DOI
- Hanft JR, Surprenant MS: Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis. J Foot Ankle Surg 41:291–299, 2002 · DOI
- Steed DL, and the Diabetic Foot Ulcer Study Group: Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity diabetic foot ulcers. J Vasc Surg 21:71–81, 1995 · DOI
- Veves A, Falanga V, Armstrong D, Sabolinski M, for the Diabetic Foot Ulcer Group: Graftskin, a human skin equivalent, is effective in the management of non-infected neuropathic diabetic foot ulcers: a prospective randomized multi-center clinical trial. Diabetes Care 24:290–295, 2001 · DOI · Paper page
- Pinney E, Liu K, Sheeman B, Mansbridge J: Human three-dimensional fibroblasts cultures express angiogenic activity. J Cell Physiol 183:74–82, 2000 · DOI
- Krejci-Papa NC, Hoang A, Hansbrough JF: Fibroblast sheets enable epithelialization of wounds that do not support keratinocyte migration. Tissue Engin 5:555–561, 1999 · DOI
- Kern A, Liu K, Mansbridge J: Modification of fibroblast interferon-gamma response by dermal fibroblast extracellular matrix. Ann N Y Acad Sci 961: 364–367, 2002 · DOI
- Falanga V: Classifications for wound bed preparation and stimulation of chronic wounds. Wound Rep Regen 8:347–352, 2000 · DOI
Cited by
Armstrong, D. G., & Lavery, L. A. (2005) · The Lancet · doi:10.1016/s0140-6736(05)67695-7 · Cited by 963
Tissue Engineering and Regenerative Medicine: History, Progress, and Challenges
Berthiaume, F., Maguire, T. J., & Yarmush, M. L. (2011) · Annual Review of Chemical and Biomolecular Engineering · doi:10.1146/annurev-chembioeng-061010-114257 · Cited by 734
Wound healing and treating wounds
Morton, L. M., & Phillips, T. J. (2016) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2015.08.068 · Cited by 475
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
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
Dermal Matrices and Bioengineered Skin Substitutes: A Critical Review of Current Options
Debels, H., Hamdi, M., Abberton, K., & Morrison, W. (2015) · Plastic and Reconstructive Surgery Global Open · doi:10.1097/gox.0000000000000219 · Cited by 227
Brem, H., Kodra, A., Golinko, M. S., Entero, H., Stojadinovic, O., Wang, V. M., Sheahan, C. M., Weinberg, A. D., Woo, S. L. C., Paul Ehrlich, H., et al. (2009) · Journal of Investigative Dermatology · doi:10.1038/jid.2009.26 · Cited by 182
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
Polydeoxyribonucleotide-delivering therapeutic hydrogel for diabetic wound healing
Shin, D. Y., Park, J.-U., Choi, M.-H., Kim, S., Kim, H.-E., & Jeong, S.-H. (2020) · Scientific Reports · doi:10.1038/s41598-020-74004-0 · Cited by 77
Functional molecule-mediated assembled copper nanozymes for diabetic wound healing
Huang, W., Xu, P., Fu, X., Yang, J., Jing, W., Cai, Y., Zhou, Y., Tao, R., & Yang, Z. (2023) · Journal of Nanobiotechnology · doi:10.1186/s12951-023-02048-1 · Cited by 47
The FDA and designing clinical trials for chronic cutaneous ulcers
Maderal, A. D., Vivas, A. C., Eaglstein, W. H., & Kirsner, R. S. (2012) · Seminars in Cell & Developmental Biology · doi:10.1016/j.semcdb.2012.09.014 · Cited by 41
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
Diabetic Foot Ulcers: Evaluation and Management
Maderal, A. D., Vivas, A. C., Zwick, T. G., & Kirsner, R. S. (2012) · Hospital Practice · doi:10.3810/hp.2012.08.994 · Cited by 15
Metadata
- Authors
- Marston, W. A., Hanft, J., Norwood, P., Pollak, R., & for the Dermagraft Diabetic Foot Ulcer Study Group
- Affiliations
- University of North Carolina School of Medicine, Chapel Hill, North Carolina
- Foot & Ankle Institute of South Florida, South Miami, Florida
- Valley Endocrine, Fresno, California
- University of Texas Health Science Center, San Antonio, Texas; and the Dermagraft Joint Venture, La Jolla, California
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2003-06-01
- Volume
- 26
- Issue
- 6
- Pages
- 1701-1705
- ISSN
- 0149-5992
- 1935-5548
- Cited by
- 613
- References
- 0
- Language
- en
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.
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.