Trial reportWound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society
Formulated collagen gel accelerates healing rate immediately after application in patients with diabetic neuropathic foot ulcers.
Trial report in Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 68 citations in OpenAlex.
- Pooled it
- Wound Conforming Matrix Containing Purified Homogenate of Dermal Collagen Promotes Healing of Diabetic Neuropathic Foot Ulcers: Comparative Analysis Versus Standard of Care.Advances in wound care · 2020Trial
- EUREKA study - the evaluation of real-life use of a biophotonic system in chronic wound management: an interim analysis.Drug design, development and therapy · 2017Trial
- Mechanisms and Interventions of Diabetic Wound Healing.Current diabetes reviews · 2026Review
- Growth factors and growth factor gene therapies for treating chronic wounds.Bioengineering & translational medicine · 2024Review
- Functionalised biomaterials as synthetic extracellular matrices to promote vascularisation and healing of diabetic wounds.Cell and tissue research · 2024Review
- Thermosensitive and antioxidant wound dressings capable of adaptively regulating TGFβ pathways promote diabetic wound healing.NPJ Regenerative medicine · 2023Article
- Matrices Activated with Messenger RNA.Journal of functional biomaterials · 2023Review
- Designing electrospun fiber platforms for efficient delivery of genetic material and genome editing tools.Advanced drug delivery reviews · 2022Review
- Subcutaneous toxicity of a dual ionically cross-linked atelocollagen and sodium hyaluronate gel: Rat in vivo study for biological safety evaluation of the injectable hydrogel.Toxicology reports · 2021Article
- Cellulose/Collagen Dressings for Diabetic Foot Ulcer: A Review.Pharmaceutics · 2020Review
- Enhanced wound healing via collagen-turnover-driven transfer of PDGF-BB gene in a murine wound model.ACS applied bio materials · 2020Article
- Review: Multimodal bioactive material approaches for wound healing.APL bioengineering · 2018Review
- Innovations in gene and growth factor delivery systems for diabetic wound healing.Journal of tissue engineering and regenerative medicine · 2018Review
- Encapsulation of primary dopaminergic neurons in a GDNF-loaded collagen hydrogel increases their survival, re-innervation and function after intra-striatal transplantation.Scientific reports · 2017Article
- Efficacy of a new multifunctional surfactant-based biomaterial dressing with 1% silver sulphadiazine in chronic wounds.International wound journal · 2016Article
- Integration of growth factor gene delivery with collagen-triggered wound repair cascades using collagen-mimetic peptides.Bioengineering & translational medicine · 2016Article
- Quality Randomized Clinical Trials of Topical Diabetic Foot Ulcer Healing Agents.Advances in wound care · 2016Review
- Collagen-based wound dressings for the treatment of diabetes-related foot ulcers: a systematic review.Diabetes, metabolic syndrome and obesity : targets and therapy · 2013Article
- Treatment of nonhealing diabetic lower extremity ulcers with skin graft and autologous platelet gel: a case series.BioMed research international · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 11 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We assessed the safety and efficacy of Formulated Collagen Gel (FCG) alone and with Ad5PDGF-B (GAM501) compared with Standard of Care (SOC) in patients with 1.5-10.0 cm(2) chronic diabetic neuropathic foot ulcers that healed <30% during Run-in. Wound size was assessed by planimetry of acetate tracings and photographs in 124 patients. Comparison of data sets revealed that acetate tracings frequently overestimated areas at some sites. For per-protocol analysis, 113 patients qualified using acetate tracings but only 82 qualified using photographs. Prior animal studies suggested that collagen alone would have little effect on healing and would serve as a negative control. Surprisingly trends for increased incidence of complete closure were observed for both GAM501 (41%) and FCG (45%) vs. Standard of Care (31%). By photographic data, Standard of Care had no significant effect on change in wound radius (mm/week) from during Run-in to Week 1 (-0.06 ± 0.32 to 0.78 ± 1.53, p=ns) but both FCG (-0.08 ± 0.61 to 1.97 ± 1.77, p<0.002) and GAM501 (-0.02 ± 0.58 to 1.46 ± 1.37, p<0.002) significantly increased healing rates that gradually declined over subsequent weeks. Both GAM501 and FCG appeared to be safe and well tolerated, and alternate dosing schedules hold promise to improve overall complete wound closure in adequately powered trials.
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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.