Trial reportAdvances in skin & wound care2019
A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix.
Trial report in Advances in skin & wound care, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03044132 (A Prospective Trial Measuring the Clinical Outcomes for DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective Trial Measuring the Clinical Outcomes for DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Effectiveness and safety of dermal matrix used for diabetic foot ulcer: a systematic review and meta-analysis of randomized controlled trials.BMC endocrine disorders · 2024Pooled it
- Long-Term Clinical and Radiologic Evaluation of Micronized Acellular Dermal Matrix-Assisted Reconstruction in Diabetes-Related and Traumatic Foot Wounds With Bone Defects.International wound journal · 2026Article
- Clinical applications of machine learning for infection assessment in diabetic foot ulcers.Frontiers in physiology · 2026Review
- Article
- Construction and validation of a deep learning-based diagnostic model for segmentation and classification of diabetic foot.Frontiers in endocrinology · 2025Article
- Decellularized Human Dermis for Orthoplastic Extremity Reconstruction.Bioengineering (Basel, Switzerland) · 2024Review
- Updates on Recent Clinical Assessment of Commercial Chronic Wound Care Products.Advanced healthcare materials · 2023Review
- Fibronectin in hyperglycaemia and its potential use in the treatment of diabetic foot ulcers: A review.International wound journal · 2023Review
- Acellular dermal matrix in reconstructive surgery: Applications, benefits, and cost.Frontiers in transplantation · 2023Review
- Integrating RNA-sequencing and network analysis to explore the mechanism of topical Pien Tze Huang treatment on diabetic wounds.Frontiers in pharmacology · 2023Article
- Acellular Dermal Matrix in Plastic and Reconstructive Surgery.Physiological research · 2022Article
- An Effective Method for Decellularization of Human Foreskin: Implications for Skin Regeneration in Small Wounds.Cell journal · 2022Article
- Advances in Immunomodulation and Immune Engineering Approaches to Improve Healing of Extremity Wounds.International journal of molecular sciences · 2022Review
- Use of confocal microscopy imaging for in vitro assessment of adipose-derived mesenchymal stromal cells seeding on acellular dermal matrices: 3D reconstruction based on collagen autofluorescence.Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) · 2022Article
- Abdominoplasty Skin-Based Dressing for Deep Wound Treatment-Evaluation of Different Methods of Preparation on Therapeutic Potential.Pharmaceutics · 2021Article
- Membranous Extracellular Matrix-Based Scaffolds for Skin Wound Healing.Pharmaceutics · 2021Review
- Observation of the effect of one-to-one education on high-risk cases of diabetic foot.World journal of clinical cases · 2021Article
- Review
- Acellular dermal matrix in skin wound healing in rabbits - histological and histomorphometric analyses.Clinics (Sao Paulo, Brazil) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis prospective, multicenter study evaluated the efficacy and safety of an acellular dermal matrix allograft, DermACELL (D-ADM; LifeNet Health, Virginia Beach, Virginia), in the treatment of large, complex diabetic foot ulcers (DFUs) that probed to tendon or bone.
methodsInclusion criteria were Wagner grade 3 or 4 DFUs between 4 weeks and 1 year in duration. All participants received one application of D-ADM at baseline and could receive one additional application if wound healing arrested. Ulcers were assessed weekly for 16 weeks using a laser measuring device.
resultsSixty-one participants were enrolled, with an average wound area of 29.0 cm; 59 of these ulcers showed exposed bone. The entire per-protocol population (n = 47) achieved 100% granulation. The mean time to 100% granulation was 4.0 weeks with an average of 1.2 applications of D-ADM. Mean percent wound area reduction was 80.3% at 16 weeks. Those DFUs 15 cm or smaller were substantially more likely to close than DFUs larger than 29 cm (P = .0008) over a 16-week duration. No complications were associated with the use of the studied matrix.
conclusionsThe D-ADM demonstrated the ability to rapidly reduce the size of large, complex DFUs with exposed bone. Some wounds did not completely heal by 16 weeks; however, the significant reduction in size suggests that these large, complex wounds may heal if given more time.
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