Trial reportTrials2011
A prospective, double-blind, randomized, controlled clinical trial comparing standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care only for the treatment of chronic, non-healing ulcers of the lower limb in patients with diabetes mellitus: a study protocol.
Trial report in Trials, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00621608 (A Prospective, Double-blind, Randomized, Controlled Clinical Trial Comparing Standard Wound Care With Adjunctive Hyperbaric Oxygen Therapy), which is not on this map. Cited by 16 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.
A Prospective, Double-blind, Randomized, Controlled Clinical Trial Comparing Standard Wound Care With Adjunctive Hyperbaric Oxygen Therapy (HBOT) to Standard Wound Care Only for the Treatment of Chronic, Non-healing Ulcers of the Lower Limb in Patients With Diabetes Mellitus.
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.
- Hyperbaric oxygen therapy for chronic wounds.The Cochrane database of systematic reviews · 2015Pooled it
- Gas Therapies for Chronic Wounds: Comparative Effectiveness, Safety, and Evidence Certainty-A Systematic Review and Network Meta-Analysis.Journal of clinical medicine · 2026Article
- Comment on "Sitagliptin, a DPP-4 Inhibitor, Effectively Promotes the Healing of Diabetic Foot Ulcer: A Randomized Controlled Trial".Journal of diabetes · 2025Article
- Relationship Between Symmetrical Peripheral Gangrene Patients and Using Vasopressors in the Intensive Care Unit.Cureus · 2024Review
- Review
- Functional Biomaterials for Treatment of Chronic Wound.Frontiers in bioengineering and biotechnology · 2020Review
- Hyperbaric oxygen for treatment of diabetic foot ulcers: love you more than I can say.Annals of translational medicine · 2018Article
- A Retrospective Chart Review of Chronic Wound Patients Treated with Topical Oxygen Therapy.Advances in wound care · 2017Article
- Chronic Wound Healing: A Review of Current Management and Treatments.Advances in therapy · 2017Review
- Additive enhancement of wound healing in diabetic mice by low level light and topical CoQ10.Scientific reports · 2016Article
- Shedding light on a new treatment for diabetic wound healing: a review on phototherapy.TheScientificWorldJournal · 2014Review
- Perioperative management of diabetic foot.Frontiers in pharmacology · 2014Article
- IGF-1 Increases with Hyperbaric Oxygen Therapy and Promotes Wound Healing in Diabetic Foot Ulcers.Journal of diabetes research · 2013Article
- From ulcer to infection: an update on clinical practice and adjunctive treatments of diabetic foot ulcers.Current infectious disease reports · 2012Article
- An exploratory clinical trial for combination wound therapy with a novel medical matrix and fibroblast growth factor in patients with chronic skin ulcers: a study protocol.American journal of translational research · 2012Article
- Hyperbaric oxygen therapy improves the effect of keloid surgery and radiotherapy by reducing the recurrence rate.Journal of Zhejiang University. Science. BArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIt has been suggested that the use of adjunctive hyperbaric oxygen therapy improves the healing of diabetic foot ulcers, and decreases the risk of lower extremity amputations. A limited number of studies have used a double blind approach to evaluate the efficacy of hyperbaric oxygen therapy in the treatment of diabetic ulcers. The primary aim of this study is to assess the efficacy of hyperbaric oxygen therapy plus standard wound care compared with standard wound care alone in preventing the need for major amputation in patients with diabetes mellitus and chronic ulcers of the lower limb. METHODS/
designOne hundred and eighteen (59 patients per arm) patients with non-healing diabetic ulcers of the lower limb, referred to the Judy Dan Research and Treatment Centre are being recruited if they are at least 18 years of age, have either Type 1 or 2 diabetes with a Wagner grading of foot lesions 2, 3 or 4 on lower limb not healing for at least 4 weeks. Patients receive hyperbaric oxygen therapy every day for 6 weeks during the treatment phase and are provided ongoing wound care and weekly assessments. Patients are required to return to the study centre every week for an additional 6 weeks of follow-up for wound evaluation and management. The primary outcome is freedom from having, or meeting the criteria for, a major amputation (below knee amputation, or metatarsal level) up to 12 weeks after randomization. The decision to amputate is made by a vascular surgeon. Other outcomes include wound healing, effectiveness, safety, healthcare resource utilization, quality of life, and cost-effectiveness. The study will run for a total of about 3 years. DISCUSSION: The results of this study will provide detailed information on the efficacy of hyperbaric oxygen therapy for the treatment of non-healing ulcers of the lower limb. This will be the first double-blind randomized controlled trial for this health technology which evaluates the efficacy of hyperbaric oxygen therapy in prevention of amputations in diabetic patients.
trial registrationClinicalTrials.gov Identifier: NCT00621608.
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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.