Trial reportInternational wound journal2013
A prospective, multicentre, randomised controlled study of human fibroblast-derived dermal substitute (Dermagraft) in patients with venous leg ulcers.
Trial report in International wound journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 1 of them a synthesis 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
40 citing papers in PubMed, 1 synthesis or guideline pooled it, 90 citations in OpenAlex.
- Skin Substitutes for Adults With Diabetic Foot Ulcers and Venous Leg Ulcers: A Health Technology Assessment.Ontario health technology assessment series · 2021Pooled it
- An open-label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis.Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society · 2019Trial
- A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFixInternational wound journal · 2018Trial
- Safety and tolerability of topically administered autologous, apoptotic PBMC secretome (APOSEC) in dermal wounds: a randomized Phase 1 trial (MARSYAS I).Scientific reports · 2017Trial
- The effect of a connexin43-based Peptide on the healing of chronic venous leg ulcers: a multicenter, randomized trial.The Journal of investigative dermatology · 2015Trial
- A prospective, multicentre, randomised controlled study of human fibroblast-derived dermal substitute (Dermagraft) in patients with venous leg ulcers.International wound journal · 2013Trial
- A Prospective Cohort Study of Hard-to-Heal Chronic Foot and Leg Wounds Followed for up to 20 Weeks After Initiation of ReGenerating Tissue Agents (RGTA) Technology as an Add-on to Optimal Local Care.International wound journal · 2026Article
- The Use of Plant-Derived Extracellular Vesicles in Regenerative Medicine Applied to Cutaneous Wound Healing.Pharmaceutics · 2025Review
- A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg Ulcers.Health science reports · 2025Article
- Clinical Efficacy of Ovine Forestomach Matrix and Collagen/Oxidised Regenerated Cellulose for the Treatment of Venous Leg Ulcers: A Retrospective Comparative Real-World Evidence Study.International wound journal · 2025Article
- A comprehensive evaluation of dermal fibroblast therapy in clinical trials for treating skin disorders and cosmetic applications: a scoping review.Stem cell research & therapy · 2024Article
- Cellular therapeutics and immunotherapies in wound healing - on the pulse of time?Military Medical Research · 2024Review
- Advances in Skin Tissue Engineering and Regenerative Medicine.Journal of burn care & research : official publication of the American Burn Association · 2023Article
- Functionalised-biomatrix for wound healing and cutaneous regeneration: future impactful medical products in clinical translation and precision medicine.Frontiers in bioengineering and biotechnology · 2023Review
- Skin substitutes as treatment for chronic wounds: current and future directions.Frontiers in medicine · 2023Review
- Clinical Application of Bioresorbable, Synthetic, Electrospun Matrix in Wound Healing.Bioengineering (Basel, Switzerland) · 2022Article
- Convergence of Biofabrication Technologies and Cell Therapies for Wound Healing.Pharmaceutics · 2022Review
- The Discovery and Development of Natural-Based Biomaterials with Demonstrated Wound Healing Properties: A Reliable Approach in Clinical Trials.Biomedicines · 2022Review
- Pain Management in Older Adults with Chronic Wounds.Drugs & aging · 2022Review
- Chronic wounds.Nature reviews. Disease primers · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This was an open-label, prospective, multicentre, randomised controlled study to evaluate the efficacy and safety of human fibroblast-derived dermal substitute (HFDS) plus four-layer compression therapy compared with compression therapy alone in the treatment of venous leg ulcers. The primary outcome variable was the proportion of patients with completely healed study ulcers by 12 weeks. The number healed was further summarised by ulcer duration and baseline ulcer size. Sixty-four (34%) of 186 patients in the HFDS group experienced healing by week 12 compared with 56 (31%) of 180 patients in the control group (P = 0·235). For ulcers ≤ 12 months duration, 49 (52%) of 94 patients in the HFDS group versus 36 (37%) of 97 patients in the control group healed at 12 weeks (P = 0·029). For ulcers ≤ 10 cm(2), complete healing at week 12 was observed in 55 (47%) of 117 patients in the HFDS group compared with 47 (39%) of 120 patients in the control group (P = 0·223). The most common adverse events (AEs) were wound infection, cellulitis and skin ulcer. The frequency of AEs did not markedly differ between the treatment and control groups.
Indexed as
Identifiers
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.