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. 2. HBOT did improve self-assessed health staus or quality of life at 12 weeks

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.

3. Li G, Hopkins RB, Levine MA, Jin X, Bowen JM, Thabane L, Goeree R, Fedorko L, O’Reilly DJ. Relationship between hyperbaric oxygen therapy and quality of life in participants with chronic diabetic foot ulcers: data from a randomized controlled trial. Acta diabetologica. 2017 Sep 1;54(9):823-31.

'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 NNH9 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
EQ-5D (11111 no problems to 33333 extreme problems) 12 weeks	0.67	0.19	0.67	0.25	0.01	-0.02 to 0.02

 

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.

9. No differneces between groups in quality of life or health state at 12 weeks.

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

 

BACK