|
1. Rate of healing improved with hyperbaric
oxygen. |
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 |
CER
|
EER
|
RRR
|
ARR
|
NNT
|
Healed
|
4
weeks |
0 |
0.133 |
INF |
-0.133 |
-8 |
|
95%
Confidence Intervals: |
|
-0.305
to 0.039 |
NNT
= 26 to INF; NNH = 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, 2004
Email: j.c.j.kuipers@student.rug.nl
Kill or Update By: July 2006