Wang 2011.
| Methods | Open‐label, randomised controlled trial | |
| Participants | 86 people with diabetes with 93 chronic non‐healing ulcers in the foot area Group 1: 41 randomised (46 ulcers) Group 2: 45 randomised (47 ulcers) |
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| Interventions | Group 1: extracorporeal shockwave therapy (ESWT) Group 2: HBOT EWST treatment dose was ulcer size‐dependent. Treatments were conducted 2 times per week for 3 weeks for a total of 6 treatments. After ESWT, patients resumed their initial wound care protocol. Administration of additional antibiotic was discretional. HBOT was at a pressure of 2.5 ATA for 90 minutes per treatment daily for a total 20 days of treatments. Patients received the same standard wound care protocol after treatment as ESWT. |
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| Outcomes | Ulcers healed Ulcers with ≥50% improvement Unchanged ulcers Worsened ulcers |
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| Notes | 27 patients (ESWT: 12 with 14 ulcers; HBOT: 15 with 17 ulcers) also received a second course of treatment due to improved but incomplete healing of the ulcers 4 to 6 weeks from the first treatment The denominator used in the analysis was the number of ulcers not patients. Results reported for completers. Clinical trial number NCT01219127 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Described as randomised, but no statement of how randomisation sequence was generated |
| Allocation concealment (selection bias) | Unclear risk | No statement on allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "patients and healthcare providers were not blinded" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No statement on blinding of outcome assessors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "During the course of treatment, 9 patients were excluded including 2 in the ESWT group (2 poor compliance) and seven in the HBO group (7 incomplete follow‐up data)." |
| Incomplete outcome data addressed (use of intention‐to‐treat (ITT) analysis) | High risk | Patients withdrawing were not balanced in numbers across intervention groups, and reasons were not similar across groups. Analysis not undertaken using ITT |
| Selective reporting (reporting bias) | Low risk | All outcomes specified in trials register reported in article |
ATA: atmospheres absolute HADS: Hospital Anxiety and Depression Scale HBOT: hyperbaric oxygen therapy ITT: intention‐to‐treat SF‐36: Short Form (36) Health Survey