Kessler
Adjunctive hyperbaric oxygen treatment for non-ischemic diabetic foot ulcers results in more rapid healing.
| Clinical Bottom Line: 1. Rate of healing improved with hyperbaric oxygen. 2. Non-significant short term increase in chance of healing with HBOT |
Citation/s:Kessler L, Bilbault P, Ortega F, Grasso C, Passemard R, Stephan D, Pinget M, Schneider F. Hyperbaric oxygenation accelerates the healing rate of nonischemic chronic diabetic foot ulcers. Diabetes Care 2003; 26:2378-82.
Lead author's name and fax: Laurance Kessler, MD, PHD [laurance.kessler@medicine.u-strasbg.fr]
Three-part Clinical Question: In diabetic patients with foot ulcers, does the addition of hyperbaric oxygen therapy to conventional treatment result in an improvement in healing?
Search Terms: Hyperbaric oxygen therapy, Diabetic foot ulcers
The Study:Single-blinded randomised controlled trial without intention-to-treat.
The Study Patients: Foot ulcer with no improvement for three months despite stabilization of glycemia, absence of clinical local infection and satisfactory off-loading measures. Non-ischemic (TcPO2 > 30 mmHg).
Control group (N = 15; 14 analysed): Hospitalization for 2 weeks with standard wound care, keeping weight of affected foot, orthopedic device, optimization of metabolic control +/- antibiotics.
Experimental group (N = 15; 13 analysed): As control group plus hyperbaric oxygen treatment for 2 weeks, 5 days a week, twice daily 90 min at 2.5 ATA.
The Evidence:
| Outcome | Time to Outcome | Control Group | HBO Group | Relative Risk Reduction | Absolute Risk Reduction | NNT |
| Healed | 4 weeks | 0 | 0.133 | INF | -0.133 | -8 |
| ^ | 95% Confidence Intervals: | -0.305 to 0.039 | NNT 26 to INFNNH 3 to INF |
| Measure | Control Group | Experimental Group | Difference | 95% CI | ||
| ^ | Mean | SD | Mean | SD | ^ | ^ |
| Reduction in ulcer size 0 - 2 weeks. |
41.8% | 25.5% | 21.7% | 16.9% | 20.1 | 2.8 to 37.4 |
| Reduction in ulcer size 2-4 weeks. |
48.1% | 30.3% | 41.7% | 27.3% | 6.4 | -16.5 to 29.3 |
| Reduction in ulcer size 0 - 4 weeks. |
61.9% | 23.3% | 55.1% | 21.5% | 6.8 | -11.0 to 24.6 |
Comments: 1. Partly blinded study. 2. Small study with low power to detect differences in final healing. 3. Short-term outcomes only
Appraised by: Jasper Kuipers and Mike Bennett, Prince of Wales Hospital, Sydney, Australia; Monday, May 10, 2004Email: [j.c.j.kuipers@student.rug.nl] Kill or Update By: July 2021
