Fedorko
Hyperbaric oxygen therapy did not reduce indications for amputation in patients with diabetic ulcers
| 1. HBOT did not reduce indication for amputation, reduce wound size or improve healing. |
Citation/s: 1.Fedorko L, Bowen JM, Jones W, Oreopoulos G, Goeree R, Hopkins RB, O’Reilly DJ. Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. Diabetes Care 2016; 39, 392-399. 2. O'Reilly D, Linden R, Fedorko L, Tarride JE, Jones WG, Bowen JM, Goeree R. A prospective, double-blind, randomized, controlled clinical trial comparing standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care only for the treatment of chronic, non-healing ulcers of the lower limb in patients with diabetes mellitus: a study protocol. Trials. 2011 Mar 7;12:69. doi: 10.1186/1745-6215-12-69.
- Lead author's name and email: ludwik.fedorko@uhn.ca
Three-part Clinical Question: Does hyperbaric oxygen therapy reduce indications for amputation in patients with diabetes with nonhealing ulcers of the lower limb?
Search Terms: Diabetes, ulcer, chronic wound, wound care, amputation
The Study: Double-blinded concealed randomised controlled trial with intention-to-treat. The Study Patients: Ulcer of the lower limb or foot present for at least 4 weeks Control group (N = 54; 54 analysed): Breathing air at 1.3ATA daily for 30 treatments over 6 weeks, plus standard wound care of minimum 2 dressing changes per week Experimental group (N = 49; 49 analysed): Breathing 100% O2 at 2.4ATA
The Evidence:
| Outcome | Time to Outcome | Control group rate | HBO group rate | Relative risk reduction | Absolute risk reduction | NNT |
| Adjudicated indication for major or minor amputation (ITT) | 6 weeks | 0.48 | 0.51 | 4% | 0.01 | 111 |
| ^ | 95% CIs: | -43% to 50% | -0.11 to 0.13 | NNT 8 to INF; NNH 9 to INF |
| Measure | Control Group | HBO Group | Difference | 95% CI | ||
| ^ | Mean | SD | Mean | SD | ^ | ^ |
| Wound measurement (reduction in digital surface area at 12 weeks) | 1.8 | 0.42 | 1.9 | 0.39 | -0.10 | -0.15 to 0.06 |
| Non-Event Outcomes | Time to outcome/s | Control group | HBO group | P-value |
| Wounds healed | 12 weeks | 12 | 10 | 0.823 |
- Comments:
1. Underpowered based on an estimated sample size of 118 patients. The methods used to determine sample size or expected event rates are unclear.
2. Only 87 patients analysed as per protocol (had completed at least 27 treatments or healed before protocol end). Intention to treat analysis captured only 103 patients.
3. There was a change in outcome assessment from examination by a vascular surgeon to assessment of clinical notes and photographs between the ethics protocol and the published paper. This method of assessment does not seem to have been validated.
4. Very short outcomes at only 12 weeks from first treatment session.
5. Some baseline differences between groups may have biased the outcome.
6. No attempt to demonstrate hypoxia as is usual in patient selection for treatment.
7. Trans-metatarsal amputation was included in the definition of ‘major amputation’ which is unusual.
8. No clear rationale for excluding patients who had undergone revascularisation in the previous 3 months.
Appraised by: Katherine Witheridge Department of Diving and Hyperbaric Medicine Prince of Wales Hospital ; Monday, 2 July 2018
Email: katherine.witheridge@health.nsw.gov.au
Kill or Update By: July 2021
