Hyperbaric oxygen therapy (HBOT) is comparable to standard therapy in several outcomes—including healed ulcer rate, risk of amputations, and adverse events—according to the authors of a meta-analysis of patients with diabetic foot ulcers. The researchers, who recently reported these results in Clinical Therapeutics, also found that HBOT results in a greater reduction in wound area than standard therapy.
“Diabetic foot ulcers and chronic wounds increase amputation risk in patients with diabetes,” wrote researchers led by Di Zhao, MD, Department of Orthopedics, the First Affiliated Hospital of Shantou University Medical College, in Shantou, Guangdong, China. “Diabetic foot ulcers are a major health care problem for patients with diabetes and a major contributor to societal costs of diabetes.”
Although HBOT has been used for decades as an adjunctive treatment for chronic diabetic foot ulcers, its efficacy and safety profile have been questioned in recent years due to conflicting data and small sample sizes in clinical trials. Some studies have found HBOT offered no advantage in comprehensive wound therapy, while at least one trial reported that HBOT significantly improved healing in foot ulcers and also reduced amputations.
Standard therapy for diabetic foot ulcers involves pressure reduction, debridement of necrotic tissue, moist dressings, and antibiotic management of infection. But none of these effectively increases delivery of oxygen to the wound. That’s where HBOT comes in—it reduces ischemia, stimulates wound repair, releases bone marrow stem cells, and enhances host antimicrobial responses, the researchers explained.
“With more and more attention focusing on diabetic foot treatment, a number of clinical trials have been conducted, and meta-analyses are needed to evaluate the efficacy and safety profile of HBOT,” wrote Dr. Zhou and colleagues.
To that end, they conducted a meta-analysis of nine randomized clinical trials involving a total of 526 patients with diabetic foot ulcers who were randomized to receive either HBOT or standard therapy (268 patients each).
Results of their meta-analysis found:
- No difference between HBOT and standard therapy in the incidence of healed ulcers (RR=2.22; 95% CI, 0.87-5.62; P=0.32).
- Comparable results for HBOT and standard therapy in the incidence of major amputations (RR=0.47; 95% CI, 0.17-1.28; P=0.14).
- Similar incidence of minor amputations in the HBOT and standard therapy groups (RR=0.95; 95% CI, 0.39-2.29; P=0.91).
- No significant difference between HBOT and standard therapy in reported adverse events (RR=1.00; 95% CI, 0.64-1.56; P=0.99).
- A greater reduction in the ulcer wound area with HBOT than with standard therapy (SMD=1.12; 95% CI, 0.20-2.04; P=0.04).
“HBOT can serve as a clinically meaningful adjuvant therapy for patients with diabetic foot ulcers,” Dr. Zhou and colleagues concluded.
But this isn’t the final word on the subject, they acknowledged. “[B]ecause of various limitations and the quality of some evidence, large randomized clinical trials associated with a unified HBOT technique are needed to further explore the efficacy and safety profile of HBOT in clinical practice,” they recommended.