Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial | Canada Hyperbarics Skip to main content
RCT Diabetes Care 2016 Canadian

Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

Fedorko L, Bowen J, Jones W, Oreopoulos G, Goeree R, Hopkins R, et al. — Diabetes Care, 2016

Tier 1, Curated

Manually reviewed and included in the Canada Hyperbarics research database.

Summary

What Researchers Did

Patients with diabetes and chronic foot ulcers were randomized to receive either hyperbaric oxygen therapy (HBOT) or sham treatment, in addition to comprehensive wound care, to assess its efficacy in reducing major amputation and improving wound healing.

What They Found

At 12 weeks, criteria for major amputation were met in 13 of 54 patients (24%) in the sham group and 11 of 49 patients (22%) in the HBOT group, showing no statistically significant difference (odds ratio 0.91, P = 0.846). Similarly, wound healing occurred in 12 (22%) patients in the sham group and 10 (20%) in the HBOT group, also without a significant difference (P = 0.823).

What This Means for Canadian Patients

Canadian patients with diabetic foot ulcers may not benefit from hyperbaric oxygen therapy as a means to prevent major amputation or improve wound healing. This suggests that resources might be better directed towards other proven comprehensive wound care strategies.

Canadian Relevance

This study was conducted in Canada, making its findings directly relevant to Canadian healthcare practices and patient populations.

Study Limitations

The study's findings are specific to patients with Wagner grade 2-4 diabetic foot lesions and a 12-week follow-up, which may limit generalizability to other ulcer severities or longer-term outcomes.

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Study Details

Study Type RCT
Category Wound Care
Source Pubmed
PubMed ID 26740639
Year Published 2016
Journal Diabetes Care
MeSH Terms Aged; Amputation, Surgical; Chronic Disease; Diabetic Foot; Double-Blind Method; Female; Humans; Hyperbaric Oxygenation; Lower Extremity; Male; Middle Aged; Prospective Studies; Wound Healing

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Disclaimer: This study summary is provided for informational and educational purposes only. It does not constitute medical advice. The information presented reflects the findings of the original research authors and may not represent the views of Canada Hyperbarics. Always consult a qualified healthcare professional before making treatment decisions.