Efficacy of topical wound oxygen therapy in healing chronic diabetic foot ulcers: systematic review and meta-analysis.
Open accessAbstract
Objective: To conduct a systematic review and meta-analysis of recently published randomized controlled trials (RCTs) that employed the use of topical oxygen therapy (TOT) as an adjunct therapy in the treatment of Wagner 1 and 2 diabetic foot ulcers. Approach: Following a literature search of eligible studies from 2010 onward, four RCTs were included. Studies were analyzed for patient and wound characteristics, outcomes, risk of bias, and quality of the evidence assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. A random-effects meta-analysis for complete wound healing was carried out due to statistical heterogeneity of included studies. Results: Risk of bias judgment (RoB2 analysis) resulted in one low-risk trial and three trials with some risk. One study was determined to be the origin of the statistical heterogeneity. Pooled results showed statistical significance with a risk ratio (RR) of 1.59 (95% confidence interval [CI]: 1.07–2.37; p = 0.021). Sensitivity analysis, based on imputed values for missing outcomes, demonstrated that both the RR and 95% CIs changed little. The GRADE ratings for each domain were as follows: (a) risk of bias: moderate (3); (b) imprecision: moderate (2), high (1); (c) inconsistency: low (2), high (1); (d) indirectness: moderate (2), high (1); and (e) publication bias: moderate (1), high (2). Overall, the evidence was moderate. Innovation: Our study shows that TOT is a viable diabetic foot ulcer therapy. Conclusions: These data support the use of TOT for the treatment of chronic Wagner 1 or 2 diabetic foot ulcers in the absence of infection and ischemia.
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In a randomized clinical trial of 269 patients, topical fibrin and leucocyte platelet patch improved healing at 20 wk compared with standard of care (34% vs 22% healed; odds ratio, 1.58; 95% CI, 1.04-2.40).
“Randomized clinical trial of 269 patients reported improved healing at 20 wk with patch compared with standard of care consisting of adequate off-loading, wound debridement, and moisture-balancing dressings (34% vs 22% healed; odds ratio, 1.58; 95% CI, 1.04-2.40).65”
From Diabetic Foot Ulcers (2023) · cites this paper as [65]
The Methods (Data extraction and risk of bias analysis; page unavailable) describe standard care as including offloading, debridement, and dressings that maintain a moist wound bed. But the Results (Study details; page unavailable) report topical oxygen trials with 12-week outcomes, not a 269-patient platelet-patch trial at 20 weeks; the claimed healing rates and odds ratio are not supported by this copy. (LLM, conf=0.83)
Experimental — accuracy not yet measuredA topical fibrin and leucocyte platelet patch has reported efficacy in a large randomized clinical trial.
“A topical fibrin and leucocyte platelet patch has reported efficacy in a large randomized clinical trial.65”
From Diabetic Foot Ulcers (2023) · cites this paper as [65]
The Discussion and Results > Study details sections assess topical wound oxygen therapy, not a fibrin-and-leucocyte platelet patch. Searches for the patch and LeucoPatch found no passage in our copy addressing its efficacy or a randomized trial of it. (LLM, conf=0.76)
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References 33 · Cited by 55
Research works printed but not linked: 2
- [31]Siemieniuk R, Guyatt G. What is GRADE? BMJ Best Practice. https://bestpractice.bmj.com/info/us/toolkit/learn-ebm/what-is-grade/ (last accessed February 2, 2022).
- [34]Kaufman H, Gurevich M, Tamir E, et al. Topical oxygen therapy used to improve wound healing in a large retrospective study of wounds of mixed aetiology. Wounds Int 2021; 12: 63– 68.
- Authors
- Carter, M. J., Frykberg, R. G., Oropallo, A., Sen, C. K., Armstrong, D. G., Nair, H. K. R., & Serena, T. E.
- Affiliations
- Strategic Solutions, Inc., Bozeman, Montana, USA.
- Midwestern University (US)
- Northwell Health (US)
- Indiana University Indianapolis (US)
- University of Southern California (US)
- Hospital Kuala Lumpur (MY)
- SerenaGroup Research Foundation, Cambridge, Massachusetts, USA.
- Corresponding author
- Carter, Marissa J.
- ORCID
- Venue
- Advances in Wound Care
- Publisher
- SAGE Publications
- Published
- 2023-01-18
- Volume
- 12
- Issue
- 4
- Pages
- 177-186
- ISSN
- 2162-1918 (ISSN-L)
- 2162-1934
- PMC
- PMC9885545
- OpenAlex
- W4280613428
- Cited by
- 55
- References
- 33
- Citations by year
- 2026: 13 · 2025: 14 · 2024: 15 · 2023: 11 · 2022: 2
- FWCI
- 1.49
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Advances in Wound Care (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Funders
- National Institute of Diabetes and Digestive and Kidney Diseases (R01DK124789)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetic Foot Ulcer Assessment and Management
- Health Sciences › Medicine › Rehabilitation › Wound Healing and Treatments
- Health Sciences › Medicine › Dermatology › Skin Diseases and Diabetes
- Keywords
- topical oxygen therapy, diabetic foot ulcer, chronic wounds, wound healing, adjunctive therapy, wound infection, ischemia
- MeSH terms
- Diabetes Mellitus, Humans, Oxygen, Wound Healing, Foot Ulcer, Diabetic Foot
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