Khandelwal
Both the application of human plasma growth factor and hyperbaric oxygen improved the chance of ulcer healing compared to antiseptic dressings for diabetic ulcers
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1. Clinical impact unclear because of poor outcome reporting. |
Citation/s:1. Khandelwal S, Chaudhary P, Poddar DD, Saxena N, Singh RA, Biswal UC. Comparative study of different treatment options of grade III and IV diabetic foot ulcers to reduce the incidence of amputations. Clinics and practice. 2013 Jan 25;3(1)
Lead author's name and fax: Poras Chaudhary drporaschaudhury@yahoo.com
Three-part Clinical Question:For patients with diabetic ulcers, does the application of hyperbaric oxygen, compared to either human growth factor (locally) or dressings alone, result in improved healing
Search Terms: Diabetes mellitus;human growth factor; wound healing
The Study:Non-blinded randomised controlled trial with intention-to-treat.
The Study Patients: Diabetic patients with stage III and IV diabetic foot ulcers- (full thickness skin loss including damage down to muscle or tendon).for at least 8 weeks. Osteomyelitis excluded.
Control groups (Dressing: N = 20; 14 analysed. RhPDGF: N = 20; 19 analysed): 1) Dressing regimen only : Surgical debridement and daily dressing involving application of Eusol and hydrogen peroxide prior to dressing with povidone iodine and saline gauze. 2) Recombinant human derived growth factor (rhPDGF). Surgical debridement and daily application of gel GF preparation.
Experimental group (N = 20; 15 analysed): As above but no mention of surgical debridement. 30 treatments breathing 100% oxygen at 2.5ATA for sixty minutes daily or until healed. Had 'surgical dressings'.
The Evidence:
Outcome |
Time to Outcome |
Dressing group |
HBO group |
Relative risk reduction |
Absolute risk reduction |
NNT | |
|
Healed at end of study |
10 weeks |
0.4 |
0.6 |
-50% |
-0.2 |
-5 | |
95% CIs: |
-126% to 26% |
-0.5 to 0.1 |
NNT = 10 to INF; NNH = 2 to INF | ||||
RhPDGF |
HBO group |
Relative risk reduction |
Absolute risk reduction |
NNT | |||
0.8 |
0.6 |
25% |
0.2 |
5 | |||
95% CIs: |
-10% to 60% |
-0.08 to 0.48 |
NNT = 2 to INF; NNH = 13 to INF | ||||
Measure |
Dressing group |
HBO group |
Difference |
95% CI | ||
Mean |
SD |
Mean |
SD | |||
|
Mean time to healing (weeks) |
6.75 |
2.65 |
6.83 |
2.5 |
-0.08 |
-5.13 to 4.97 |
rhPDGF group |
HBOT group |
Difference |
95%CI | |||
Mean |
SD |
Mean |
SD |
|
| |
7.6 |
2.53 |
6.83 |
2.5 |
0.77 |
-3.69 to 5.23 | |
Comments:
1. Poorly reported study with high rate of drop-outs in some groups.
2. No figures reported for a number of outcomes.
3. Hyperbaric group may not have been debrided
4. These results are at odds with previously published data- this may reflect a different demographic and the grade and chronicity of injury
Appraised by:Mike Bennett m.bennett@unsw.edu.au; Sunday, 24 May 2020
Kill or Update By: May 2021 4.
