Document Detail

Topical wound oxygen therapy in the treatment of severe diabetic foot ulcers: a prospective controlled study.
MedLine Citation:
PMID:  20567051     Owner:  NLM     Status:  MEDLINE    
Diabetic foot ulcers (DFU) are common, difficult-to-treat, and prone to complications. A prospective, controlled study was conducted to: 1) examine the clinical efficacy of a pressurized topical oxygen therapy (TWO(2)) device in outpatients (N = 28) with severe DFU referred for care to a community wound care clinic and 2) assess ulcer reoccurrence rates after 24 months. Seventeen (17) patients received TWO(2) five times per week (60-minute treatment, pressure cycles between 5 and 50 mb) and 11 selected a silver-containing dressing changed at least twice per week (control). Patient demographics did not differ between treatment groups but wounds in the treatment group were more severe, perhaps as a result of selection bias. Ulcer duration was longer in the treatment (mean 6.1 months, SD 5.8) than in the control group (mean 3.2 months, SD 0.4) and mean baseline wound area was 4.1 cm2 (SD 4.3) in the treatment and 1.4 cm2 (SD 0.6) in the control group (P = 0.02). Fourteen (14) of 17 ulcers (82.4%) in the treatment group and five of 11 ulcers (45.5%) in the control group healed after a median of 56 and 93 days, respectively (P = 0.04). No adverse events were observed and there was no reoccurrence at the ulcer site after 24 months' follow-up in either group. Although the absence of randomization and blinding may have under- or overestimated the treatment effect of either group, the significant differences in treatment outcomes confirm the potential benefits of TWO(2) in the management of difficult-to-heal DFUs. Clinical efficacy and cost-effectiveness studies as well as studies to elucidate the mechanisms of action of TWO(2) are warranted.
Eric Blackman; Candice Moore; John Hyatt; Richard Railton; Christian Frye
Publication Detail:
Type:  Comparative Study; Controlled Clinical Trial; Journal Article    
Journal Detail:
Title:  Ostomy/wound management     Volume:  56     ISSN:  1943-2720     ISO Abbreviation:  Ostomy Wound Manage     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-06-22     Completed Date:  2010-10-21     Revised Date:  2011-04-15    
Medline Journal Info:
Nlm Unique ID:  8912029     Medline TA:  Ostomy Wound Manage     Country:  United States    
Other Details:
Languages:  eng     Pagination:  24-31     Citation Subset:  N    
AOTI, Ltd., Galway, Ireland & Unterhaching, Germany.
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MeSH Terms
Administration, Topical
Chi-Square Distribution
Chronic Disease
Diabetic Foot / classification,  diagnosis,  therapy*
Kaplan-Meier Estimate
Middle Aged
Oxygen / pharmacology,  therapeutic use*
Prospective Studies
Silver Compounds / therapeutic use*
Skin Care / methods
Treatment Outcome
Wound Healing / drug effects
Reg. No./Substance:
0/Silver Compounds; 7782-44-7/Oxygen
Comment In:
Ostomy Wound Manage. 2010 Aug;56(8):10; discussion 10

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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