Perren
Weak evidence that hyperbaric oxygen decreased depth and area of ischaemic diabetic foot ulcers
Clinical Bottom Line:
1. Hyperbaric oxygen therapy decreased wound depth, but not surface area of ischaemic diabetic foot ulcers. |
Citation:1.Perren S, Gatt A, Papanas N, Formosa C. Hyperbaric Oxygen Therapy in Ischaemic Foot Ulcers in Type 2 Diabetes: A Clinical Trial. Open Cardiovasc Med J. 2018 Aug 31;12:80-85.
Lead author's name and fax: Alfred Gatt, Fax 003562342
Three-part Clinical Question:In diabetic patients with newly diagnosed ischaemic foot ulcers, does the addition of hyperbaric oxygen to standard wound care decrease wound size.
Search Terms: Hyperbaric, diabetic foot ulcers; ischaemia
The Study:Non-blinded randomised controlled trial with intention-to-treat.
The Study Patients: Patients with T2DM, newly diagnosed ischaemic foot ulcer, and evidence of severe arterial disease.
Control group (N = 13 ; 13 analysed): Standard wound care including cleansing, good glycaemic control and improving blood supply.
Experimental group (N = 13 ; 13 analysed): As above plus 100% oxygen in chamber five days per week for two hours to a total of 40 treatments – treatment pressure not stated.
The Evidence:
Measure |
Control Group |
HBOT Group |
Difference |
95% CI | ||
Mean |
SD |
Mean |
SD | |||
Wound surface area reduction at 4 weeks (cm2) |
9.6 |
0.8 |
7.9 |
2.0 |
-1.7 |
-0.16 to 3.48 |
Mean depth of ulcer at 4 weeks (cm) |
1.3 |
0.3 |
0.7 |
0.25 |
-0.6 |
-0.69 to -0.57 |
Comments:
1. Poorly reported study. Small, unblinded trial, randomisation method not stated but patients matched for wound size and location, no sham. Some doubt about timing of outcome measure – may have been halfway through treatment!
2. Oxygen treatment regimens not given – perhaps each session was 60 minutes, twice per day, giving 40 sessions over 4 weeks.
3. Ischaemia defined as having biphasic/monophasic waveforms on Doppler and/or ABI <0.9.
Appraised by:Mary Grealish and Cecilia Bondjers POWH; Tuesday, 7 September 2021
Email: Mary.Grealish@health.nsw.gov.au
Kill or Update By: Sept 2022