Salama
The addition of hyperbaric oxygen to standard wound care increased the number of healed diabetic foot ulcers compared to wound care alone.
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1. The addition of hyperbaric oxygen increased the number of healed ulcers |
Citation/s:1. Salama SE, Eldeeb AE, Elbarbary AH, Abdelghany SE. Adjuvant hyperbaric oxygen therapy enhances healing of nonischemic diabetic foot ulcers compared with standard wound care alone. The international journal of lower extremity wounds. 2019 Mar;18(1):75-80
Lead author's name and fax: A H Elbarbary albarbary73@gmail.com
Three-part Clinical Question:In patients with chronic diabetic foot ulcers, does the addition of hyperbaric oxygenation to standard care improve healing?
Search Terms: problem wound; diabetes; foot ulcer
The Study:Non-blinded randomised controlled trial with intention-to-treat.
The Study Patients: Diabetic patients with foot ulcers Wagner Grade 2 or 3, for at least three months including 30 days of standard wound care and no evidence of important arterial disease.
Control group (N = 15; 15 analysed): Two months of standard treatment including debridement, antibiotics as indicated, metabolic control, offloading and daily moist saline dressings.
Experimental group (N = 15; 15 analysed): As above plus daily Monday to Friday, sessions of 100% oxygen breathing at 2.5 ATA for 60 minutes to a total of 20 to 40 sessions according to ulcer progress.
The Evidence:
Outcome |
Time to Outcome |
Standard care group |
HBO group |
Relative risk reduction |
Absolute risk reduction |
NNT |
|
Complete healing |
8 weeks after HBOT complete |
0.67 |
0.20 |
70% |
0.47 |
2 |
95% CIs: |
23% to 100% |
0.15 to 0.78 |
1 to 6 | |||
|
Minor amputation |
8 weeks |
0.07 |
0.07 |
0% |
0.0 |
INF |
95% CIs: |
-267% to 100% |
-0.18 to 0.18 |
NNT = 6 to INF NNH = 6 to INF | |||
Non-Event Outcomes |
Time to outcome/s |
Standard care group |
HBO group |
P-value |
|
Ulcer area (cm2, median and range) |
End of HBO treatment or two months |
7.5 (1.8 - 10.5) |
2 (0 - 4.5) |
0.0001 |
|
Ulcer area (cm2, median and range) |
Eight weeks after treatment |
3.5 (0 - 4) |
0 (0 - 2) |
0.0001 |
Comments:
1. Un-blinded study so bias is possible from patient or staff actions
2. Follow-up times are a little confusing. Patients received HBO for one to two months and then follow-up at end of treatment, four and eight weeks. Control group was followed up after two months of care but not specifically stated they were followed at four and eight weeks later (but may have been from the results table).
3. There were no major amputations and only one minor amputation in each group.
4. Regression of ulcer size reduction by number of treatments suggests increased healing with increased treatment numbers. 12 of 15 patients received between 30 and 40 treatments suggesting early stopping was in patients with poor ulcer response whatever the reason for stopping (unstated).
5. It is not clear how the sample size was determined but patients were recruited over a calendar year.
Appraised by:Mike Bennett; Wednesday, 22 April 2020
Email: m.bennett@unsw.edu.au
Kill or Update By: April 2022
