What Researchers Did
Researchers combined the results of previous studies to see whether hyperbaric oxygen therapy (HBOT) helps heal diabetic foot ulcers and prevent amputation.
What They Found
This systematic review and meta-analysis pooled data from twelve studies (six randomized controlled trials and six observational studies) out of 654 citations screened. In the randomized controlled trial data, HBOT was linked to a 60 percent reduction in major amputation risk, but this was not statistically significant (p equals .29); in the observational data, the reduction was 61 percent and was statistically significant (p equals .003). For unhealed wounds, the randomized trial data showed a relative risk of 0.54 with HBOT (p equals .10, not statistically significant), while the observational data showed a relative risk of 0.24 (p less than .0001, statistically significant). The authors concluded that due to limited randomized trial evidence, the benefits and harms of HBOT for diabetic lower limb ulcers cannot be conclusively established, and no significant effect on amputation rates was found in the randomized trial evidence or in the higher quality studies.
What This Means for Canadian Patients
For diabetic foot ulcers, this review found that the strongest evidence, from randomized controlled trials, did not show a statistically significant benefit of HBOT for reducing amputation or healing wounds, even though observational studies (which are more prone to bias) showed larger, statistically significant benefits. Patients and clinicians weighing HBOT for a diabetic ulcer should know that the more rigorous trial data in this review did not confirm a clear effect.
Canadian Relevance
No direct Canadian connection identified.
Study Limitations
The authors note that randomized controlled trial evidence was limited, and the positive results seen in observational studies were not confirmed by the higher quality randomized data, which found no significant difference in amputation rates.