Wang
Extracorporeal shock wave therapy (ESWT) more effective than HBOT for treating diabetic foot ulcers
Clinical bottom line:
| 1. ESWT was more effective at healing ulcers by the end of treatment period (NNT 3).= |
Citation/s:
Wang C-J, Wu R-W, Yang, Y-J. Treatment of diabetic foot ulcers: A comparative study of extracorporeal shockwave therapy and hyperbaric oxygen therapy. Diabetes Research and Clinical Practice 2011;92(2):187-193
Lead author's name and fax: Ching-Jen Wang Fax: +886 7 733 5515; Email: w281211@adm.cgmh.org.tw Three-part Clinical Question: Is the use of extracorporeal shockwave therapy (ESWT) more effective than hyperbaric oxygen therapy (HBOT) for the treatment of patients with chronic diabetic foot ulcers (DFUs)?
Search Terms: Diabetic foot ulcer; shockwave therapy The Study: Non-blinded randomised controlled trial without intention-to-treat.
The Study Patients: Patients with chronic non-healing diabetic foot ulcers for more than 3 months duration. Largely Wagner grade 3 and 4 diabetic foot ulcers.
Control group (N = 45; 40 analysed): HBOT daily five times a week at 2.5 ATA for 90 minutes to a total of 20 treatments. Standard wound care protocol with off-loading on the affected foot, SSD cream & antibiotic at discretion of treating physician.
Experimental group (N = 46; 44 analysed): Standard would treatment as for control, plus ESWT at ulcer area dependent dose daily five days each week.
- The Evidence:
| Outcome | Time to Outcome | ESWT Group | HBOT Group | Relative risk reduction | Absolute risk reduction | Number needed to treat |
| Completely healed ulcers | 4 weeks | 0.52 | 0.22 | 57% | 0.30 | 3 |
| ^ | 95% CI: | 21% to 94% | 0.11 to 0.49 | 2 to 9 | ||
| >50% improved ulcers | 4 weeks | 0.30 | 0.13 | 56% | 0.17 | 6 |
| ^ | 95% CI: | 2% to 100% | 0.01 to 0.34 | 3 to 195 | ||
| Unchanged ulcers | 4 weeks | 0.11 | 0.53 | 389% | 0.42 | 2 |
| ^ | 95% CI: | 232% to 546% | 0.25 to 0.60 | 2 to 4 | ||
| Non-Event Outcomes | Time to outcome/s | ESWT group | HBOT group | P-value | ||
| Blood flow perfusion scan | 4 weeks | 0.61 (0.40 to 0.79) | 0.50 (0.11 to 0.53) | 0.002 |
- Comments:
1. Potential confounders not addressed in the study include ESWT may be a form of debridement and debridement not attempted in HBOT group; ambulation, immunosuppression, smoking & renal disease not taken into account
2. No effort to determine if ulcers were hypoxic. No TcPO2 measurements done to check that HBOT was indicated.
3. Short term follow-up reduces applicability of the study. Longer term outcome not known.
4. Unblinded trial reduces confidence in the results given.
Appraised by: Darran Foo & Michael Bennett, Prince of Wales Hospital, Thursday, 18 September 2014
Email: darran.foo@student.unsw.edu.au or m.bennett@unsw.edu.au
Kill or Update By: July 2021
