Trial reportTrials2013
Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial.
Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- Comparative efficacy of advanced therapeutic modalities for diabetic foot ulcers: a systematic review and meta-analysis including NPWT, stem cells, ESWT, and bioengineered treatments.Frontiers in bioengineering and biotechnology · 2026Pooled 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
- Efficacy of acellular fish skin graft in the management of chronic ulcer: a systematic review and meta-analysis.Langenbeck's archives of surgery · 2024Pooled it
- Aging, biofilms, and diabetic foot ulcers: disrupting chronic infections with super-oxidized solutions and addressing age-related vulnerabilities.Cardiovascular diabetology. Endocrinology reports · 2025Review
- A Pilot Study Comparing a Micronized Adipose Tissue Niche versus Standard Wound Care for Treatment of Neuropathic Diabetic Foot Ulcers.Journal of clinical medicine · 2022Article
- Overview of Biologic Agents Used in Skin and Soft Tissue Reconstruction.Seminars in plastic surgery · 2022Review
- The role of keratinocyte function on the defected diabetic wound healing.International journal of burns and trauma · 2021Review
- Meta-Analysis of the Effect of Kangfuxin Liquid on Diabetic Patients with Skin Ulcers.Evidence-based complementary and alternative medicine : eCAM · 2021Article
- Mesenchymal stromal cell-derived factors promote the colonization of collagen 3D scaffolds with human skin cells.Journal of cellular and molecular medicine · 2020Article
- Guidelines on multidisciplinary approaches for the prevention and management of diabetic foot disease (2020 edition).Burns & trauma · 2020Article
- Plasma-Coated Polycaprolactone Nanofibers with Covalently Bonded Platelet-Rich Plasma Enhance Adhesion and Growth of Human Fibroblasts.Nanomaterials (Basel, Switzerland) · 2019Article
- Utility of extracellular matrix powders in tissue engineering.Organogenesis · 2018Review
- Advances in Skin Regeneration Using Tissue Engineering.International journal of molecular sciences · 2017Review
- Topical Collagen-Based Biomaterials for Chronic Wounds: Rationale and Clinical Application.Advances in wound care · 2016Review
- Article
- The Management of Diabetic Foot Ulcers with Porcine Small Intestine Submucosa Tri-Layer Matrix: A Randomized Controlled Trial.Advances in wound care · 2015Article
- Current wound healing procedures and potential care.Materials science & engineering. C, Materials for biological applications · 2015Review
- Naturally Occurring Extracellular Matrix Scaffolds for Dermal Regeneration: Do They Really Need Cells?BioMed research international · 2015Review
- Wound Healing: Biologics, Skin Substitutes, Biomembranes and Scaffolds.Healthcare (Basel, Switzerland) · 2014Review
- Epithelialization in Wound Healing: A Comprehensive Review.Advances in wound care · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundDiabetic foot ulcers (DFUs) represent a significant source of morbidity and an enormous financial burden. Standard care for DFUs involves systemic glucose control, ensuring adequate perfusion, debridement of nonviable tissue, off-loading, control of infection, local wound care and patient education, all administered by a multidisciplinary team. Unfortunately, even with the best standard of care (SOC) available, only 24% or 30% of DFUs will heal at weeks 12 or 20, respectively.The extracellular matrix (ECM) in DFUs is abnormal and its impairment has been proposed as a key target for new therapeutic devices. These devices intend to replace the aberrant ECM by implanting a matrix, either devoid of cells or enhanced with fibroblasts, keratinocytes or both as well as various growth factors. These new bioengineered skin substitutes are proposed to encourage angiogenesis and in-growth of new tissue, and to utilize living cells to generate cytokines needed for wound repair.To date, the efficacy of bioengineered ECM containing live cellular elements for improving healing above that of a SOC control group has not been compared with the efficacy of an ECM devoid of cells relative to the same SOC. Our hypothesis is that there is no difference in the improved healing effected by either of these two product types relative to SOC. METHODS/
designTo test this hypothesis we propose a randomized, single-blind, clinical trial with three arms: SOC, SOC plus Dermagraft® (bioengineered ECM containing living fibroblasts) and SOC plus Oasis® (ECM devoid of living cells) in patients with nonhealing DFUs. The primary outcome is the percentage of subjects that achieved complete wound closure by week 12. DISCUSSION: If our hypothesis is correct, then immense cost savings could be realized by using the orders-of-magnitude less expensive acellular ECM device without compromising patient health outcomes. The article describes the protocol proposed to test our hypothesis.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.