Trial reportWound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society
NorLeu3-A(1-7) stimulation of diabetic foot ulcer healing: results of a randomized, parallel-group, double-blind, placebo-controlled phase 2 clinical trial.
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. It is linked to trial NCT00796744 (Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Evaluate the Safety and Effectiveness of DSC127 in Treating Subjects With Diabetic Ulcers), which is not on this map. Cited by 14 papers.
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.
Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Evaluate the Safety and Effectiveness of DSC127 in Treating Subjects With Diabetic Ulcers
Who cites it
14 citing papers in PubMed.
- 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
- Topical administration of a connexin43-based peptide augments healing of chronic neuropathic diabetic foot ulcers: A multicenter, randomized trial.Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair SocietyTrial
- Targeting Neprilysin (NEP) pathways: A potential new hope to defeat COVID-19 ghost.Biochemical pharmacology · 2020Review
- Targeting MMP-9 in Diabetic Foot Ulcers.Pharmaceuticals (Basel, Switzerland) · 2019Review
- Improving the Innate Immune Response in Diabetes by Modifying the Renin Angiotensin System.Frontiers in immunology · 2019Article
- Publicly Reported Wound Healing Rates: The Fantasy and the Reality.Advances in wound care · 2018Review
- Gene Therapy With Angiotensin-(1-9) Preserves Left Ventricular Systolic Function After Myocardial Infarction.Journal of the American College of Cardiology · 2016Article
- New agents modulating the renin-angiotensin-aldosterone system-Will there be a new therapeutic option?Experimental biology and medicine (Maywood, N.J.) · 2016Review
- Therapeutic time window for angiotensin-(1-7) in acute lung injury.British journal of pharmacology · 2016Article
- Quality Randomized Clinical Trials of Topical Diabetic Foot Ulcer Healing Agents.Advances in wound care · 2016Review
- The Role of Connexins in Wound Healing and Repair: Novel Therapeutic Approaches.Frontiers in physiology · 2016Review
- Angiotensin-(1-7): A Novel Peptide to Treat Hypertension and Nephropathy in Diabetes?Journal of diabetes & metabolism · 2015Article
- NorLeuAdvances in wound care · 2015Review
- Emerging drugs for the treatment of diabetic ulcers.Expert opinion on emerging drugs · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
This randomized, double-blind, placebo-controlled Phase 2 clinical trial explored NorLeu(3)-A(1-7) (DSC127) safety and healing efficacy in diabetic foot ulcers. Patients with chronic, noninfected, neuropathic, or neuroischemic plantar Wagner Grade 1 or 2 foot ulcers (n = 172) were screened for nonhealing. Subjects were randomized to receive 4 weeks' once-daily topical treatment with 0.03% DSC127 (n = 26), 0.01% DSC127 (n = 27), or Placebo (n = 24), followed by 20 weeks' standard of care. DSC127 was assessed for safety (including laboratory values and adverse events), primary efficacy (% ulcers completely epithelialized at Week 12), and durability of effect. Baseline, demography, and safety parameters were compared between intent-to-treat groups and were comparable. Dose-response curves for DSC127 effect on % area reduction from baseline at Week 12 (40% placebo; 67% 0.01% DSC127; 80% 0.03% DSC127) and 24 (23% placebo; 53% 0.01% DSC127; 95% 0.03% DSC127) followed a log-linear pattern for both intent-to-treat and per-protocol populations. Covariate analysis compared reduction in ulcer area, depth, and volume from baseline; reductions in the 0.03% DSC127 group were greater at Weeks 12 and 24. Placebo-treated ulcers healed in a median 22 weeks vs. 8.5 weeks for 0.03%DSC127 (p = 0.04). This study provides preliminary evidence that DSC127 is safe and effective in accelerating the healing of diabetic foot ulcers.
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.