Trial reportInternational wound journal2018
An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow-up trial.
Trial report in International wound journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 5 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
18 citing papers in PubMed, 5 syntheses or guidelines pooled it, 43 citations in OpenAlex.
- Systematic review of the efficacy and safety of biologically and tissue-derived therapies for the treatment of diabetic foot.Frontiers in endocrinology · 2026Pooled it
- 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
- Skin Substitutes for Adults With Diabetic Foot Ulcers and Venous Leg Ulcers: A Health Technology Assessment.Ontario health technology assessment series · 2021Pooled it
- The Efficacy and Safety of Acellular Matrix Therapy for Diabetic Foot Ulcers: A Meta-Analysis of Randomized Clinical Trials.Journal of diabetes research · 2020Pooled it
- Decellularized dermis allograft for the treatment of venous leg ulceration: the DAVE RCT.The British journal of surgery · 2025Trial
- Use of a purified reconstituted bilayer matrix in the management of chronic diabetic foot ulcers improves patient outcomes vs standard of care: Results of a prospective randomised controlled multi-centre clinical trial.International wound journal · 2022Trial
- Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers.International wound journal · 2020Trial
- An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow-up trial.International wound journal · 2018Trial
- Acellular dermal matrices in reconstructive surgery; history, current implications and future perspectives for surgeons.World journal of clinical cases · 2024Review
- Limb Salvage via Surgical Soft-tissue Reconstruction With Ovine Forestomach Matrix Grafts: A Prospective Study.Plastic and reconstructive surgery. Global open · 2024Article
- Effects of different treatment measures on the efficacy of diabetic foot ulcers: a network meta-analysis.Frontiers in endocrinology · 2024Article
- Functionalised-biomatrix for wound healing and cutaneous regeneration: future impactful medical products in clinical translation and precision medicine.Frontiers in bioengineering and biotechnology · 2023Review
- Novel technique of development of human derived acellular dermal matrix.Cell and tissue banking · 2022Article
- A minimally manipulated preservation and virus inactivation method for amnion/chorion.Frontiers in bioengineering and biotechnology · 2022Article
- Article
- Adipose-Derived Stromal Cell-Sheets Sandwiched, Book-Shaped Acellular Dermal Matrix Capable of Sustained Release of Basic Fibroblast Growth Factor Promote Diabetic Wound Healing.Frontiers in cell and developmental biology · 2021Article
- An observational pilot study using a purified reconstituted bilayer matrix to treat non-healing diabetic foot ulcers.International wound journal · 2020Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 9 institutions in 1 country.
Funding
Abstract
Aseptically processed human reticular acellular dermal matrix (HR-ADM) has been previously shown to improve wound closure in 40 diabetic patients with non-healing foot ulcers. The study was extended to 40 additional patients (80 in total) to validate and extend the original findings. The entire cohort of 80 patients underwent appropriate offloading and standard of care (SOC) during a 2-week screening period and, after meeting eligibility criteria, were randomised to receive weekly applications of HR-ADM plus SOC or SOC alone for up to 12 weeks. The primary outcome was the proportion of wounds closed at 6 weeks. Sixty-eight percent (27/40) in the HR-ADM group were completely healed at 6 weeks compared with 15% (6/40) in the SOC group. The proportions of wounds healed at 12 weeks were 80% (34/40) and 30% (12/40), respectively. The mean time to heal within 12 weeks was 38 days for the HR-ADM group and 72 days for the SOC group. There was no incidence of increased adverse or serious adverse events between groups or any graft-related adverse events. The mean and median HR-ADM product costs at 12 weeks were $1200 and $680, respectively. HR-ADM is clinically superior to SOC, is cost effective relative to other comparable treatment modalities, and is an efficacious treatment for chronic non-healing diabetic foot ulcers.
Indexed as
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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.